Clinical and cost-effectiveness of an adapted intervention for preschoolers with moderate to severe intellectual disabilities displaying behaviours that challenge: the EPICC-ID RCT.

Background: Stepping Stones Triple P is an adapted intervention for parents of young children with developmental disabilities who display behaviours that challenge, aiming at teaching positive parenting techniques and promoting a positive parent-child relationship. Objective: To evaluate the clinical and cost-effectiveness of level 4 Stepping Stones Triple P in reducing behaviours that challenge in children with moderate to severe intellectual disabilities. Design, setting, participants: A parallel two-arm pragmatic multisite single-blind randomised controlled trial recruited a total of 261 dyads (parent and child). The children were aged 30-59 months and had moderate to severe intellectual disabilities. Participants were randomised, using a 3 : 2 allocation ratio, into the intervention arm (Stepping Stones Triple P; n = 155) or treatment as usual arm (n = 106). Participants were recruited from four study sites in Blackpool, North and South London and Newcastle. Intervention: Level 4 Stepping Stones Triple P consists of six group sessions and three individual phone or face-to-face contacts over 9 weeks. These were changed to remote sessions after 16 March 2020 due to the coronavirus disease 2019 pandemic. Main outcome measure: The primary outcome measure was the parent-reported Child Behaviour Checklist, which assesses the severity of behaviours that challenge. Results: We found a small non-significant difference in the mean Child Behaviour Checklist scores (-4.23, 95% CI -9.98 to 1.52, p = 0.146) in the intervention arm compared to treatment as usual at 12 months. Per protocol and complier average causal effect sensitivity analyses, which took into consideration the number of sessions attended, showed the Child Behaviour Checklist mean score difference at 12 months was lower in the intervention arm by -10.77 (95% CI -19.12 to -2.42, p = 0.014) and -11.53 (95% CI -26.97 to 3.91, p = 0.143), respectively. The Child Behaviour Checklist mean score difference between participants who were recruited before and after the coronavirus disease 2019 pandemic was estimated as -7.12 (95% CI -13.44 to -0.81) and 7.61 (95% CI -5.43 to 20.64), respectively (p = 0.046), suggesting that any effect pre-pandemic may have reversed during the pandemic. There were no differences in all secondary measures. Stepping Stones Triple P is probably value for money to deliver (-£1057.88; 95% CI -£3218.6 to -£46.67), but decisions to roll this out as an alternative to existing parenting interventions or treatment as usual may be dependent on policymaker willingness to invest in early interventions to reduce behaviours that challenge. Parents reported the intervention boosted their confidence and skills, and the group format enabled them to learn from others and benefit from peer support. There were 20 serious adverse events reported during the study, but none were associated with the intervention. Limitations: There were low attendance rates in the Stepping Stones Triple P arm, as well as the coronavirus disease 2019-related challenges with recruitment and delivery of the intervention. Conclusions: Level 4 Stepping Stones Triple P did not reduce early onset behaviours that challenge in very young children with moderate to severe intellectual disabilities. However, there was an effect on child behaviours for those who received a sufficient dose of the intervention. There is a high probability of Stepping Stones Triple P being at least cost neutral and therefore worth considering as an early therapeutic option given the long-term consequences of behaviours that challenge on people and their social networks. Future work: Further research should investigate the implementation of parenting groups for behaviours that challenge in this population, as well as the optimal mode of delivery to maximise engagement and subsequent outcomes. Study registration: This study is registered as NCT03086876 (https://www.clinicaltrials.gov/ct2/show/NCT03086876?term=Hassiotis±Angela&draw=1&rank=1). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: HTA 15/162/02) and is published in full in Health Technology Assessment; Vol. 28, No. 6. See the NIHR Funding and Awards website for further award information.

Research shows that in children without learning disabilities, parenting groups which support parents to develop skills to manage behaviours that challenge in their child can be helpful. The National Institute of Health and Care Excellence recommended that more research was needed to strengthen the evidence for such interventions for children with moderate to severe learning disability who are more likely to display behaviours that challenge in England. In this study, we tested in real-world conditions a programme called level 4 Stepping Stones Triple P, which has shown positive results in trials outside of the United Kingdom. Trained therapists delivered six groups and three individual sessions over 9 weeks to parents of children aged 30­59 months with moderate to severe learning disabilities. Two hundred and sixty-one parents were allocated to one of two arms by chance (randomisation): one received Stepping Stones Triple P and treatment as usual and the other treatment as usual only. Treatment as usual included support and advice by general practitioners or community child development teams. Our primary outcome was parent-reported child behaviour at 12 months after randomisation. We also collected data on other outcomes and carried out interviews with parents, service managers and therapists to find out their views about Stepping Stones Triple P. We did not find that Stepping Stones Triple P reduces behaviours that challenge in the child more than treatment as usual at 12 months. However, when we looked at people who received more than half of the sessions, there was a larger reduction in behaviours which suggests that Stepping Stones Triple P works for families if they attend the full programme. Stepping Stones Triple P seems to be good value for money, as we found that at 12 months (covering 10 months of costs), the Stepping Stones Triple P cost £1058 less than treatment as usual from a health and social care perspective. As such, Stepping Stones Triple P is fairly cheap to deliver and a suitable early intervention for behaviours that challenge especially because of positive feedback from parents. Throughout the trial, we included a Parent Advisory Group that oversaw study materials, interview topic guides and promotion of the study.

Mediation of 6-year mid-childhood follow-up outcomes after pre-school social communication (PACT) therapy for autistic children: randomised controlled trial.

BACKGROUND: There are very few mechanistic studies of the long-term impact of psychosocial interventions in childhood. The parent-mediated Paediatric Autism Communication Therapy (PACT) RCT showed sustained effects on autistic child outcomes from pre-school to mid-childhood. We investigated the mechanism by which the PACT intervention achieved these effects. METHODS: Of 152 children randomised to receive PACT or treatment as usual between 2 and 5 years of age, 121 (79.6%) were followed 5-6 years after the endpoint at a mean age of 10.5 years. Assessors, blind to the intervention group, measured Autism Diagnostic Observation Scale Calibrated Severity Score (ADOS CSS) for child autistic behaviours and Teacher Vineland (TVABS) for adaptive behaviour in school. Hypothesised mediators were child communication initiations with caregivers in a standard play observation (Dyadic Communication Measure for Autism, DCMA). Hypothesised moderators of mediation were baseline child non-verbal age equivalent scores (AE), communication and symbolic development (CSBS) and 'insistence on sameness' (IS). Structural equation modelling was used in a repeated measures mediation design. RESULTS: Good model fits were obtained. The treatment effect on child dyadic initiation with the caregiver was sustained through the follow-up period. Increased child initiation at treatment midpoint mediated the majority (73%) of the treatment effect on follow-up ADOS CSS. A combination of partial mediation from midpoint child initiations and the direct effect of treatment also contributed to a near-significant total effect on follow-up TVABS. No moderation of this mediation was found for AE, CSBS or IS. CONCLUSIONS: Early sustained increase in an autistic child's communication initiation with their caregiver is largely responsible for the long-term effects from PACT therapy on autistic and adaptive behaviour outcomes. This supports the theoretical logic model of PACT therapy but also illuminates fundamental causal processes of social and adaptive development in autism over time: early social engagement in autism can be improved and this can have long-term generalised outcome effects.

'Turning up and tuning in'. Factors associated with parental non-attendance and non-adherence in intervention for young children with speech, language communication needs.

BACKGROUND: When parents bring their child to appointments and then adhere to agreed speech and language therapy (SLT) recommendations, there is the potential to increase the intensity of the intervention, support generalization and improve outcomes. In SLT, however, little is known about factors that may promote attendance or adherence. Studies in other clinical areas such in medicine, psychology and physiotherapy have identified risk factors for non-attendance or non-adherence that are multifactorial and variable dependent on, for example, population and intervention. AIMS: To identify rates of non-attendance and non-adherence, and to identify parent or child factors associated with parent involvement in intervention for children under 5 years of age receiving SLT. METHODS: Parents completed questionnaires at two time points assessing the domains of parents' beliefs (problem perceptions, self-efficacy), personal circumstances (socio-demographics, family functioning), treatment experience and child factors. Predictors of parent attendance and adherence were identified through multiple regression analyses. Non-attendance rates were identified via local health records and non-adherence ascertained using a specific parent-reported measure within the treatment experience domain. RESULTS: Participants (N = 199) were predominantly mothers, and were ethnically and socio-economically diverse, speaking a wide range of languages. Their children presented with a range of speech, language communication needs (SLCN). The rate of non-attendance was 25% and the main predictors of non-attendance were maternal age, education level and two factors within the parent beliefs domain. This model explained 40% of the variance in attendance. The rate of non-adherence in this cohort was 26% with parental rating of the importance of a recommendation and self-efficacy beliefs predicting adherence; this explained 56% of the variance in adherence to SLT recommendations at home. CONCLUSIONS & IMPLICATIONS: Our research has provided preliminary evidence of the influence of parents' beliefs, personal circumstances and treatment experiences on their involvement in their child's therapy. Speech and language therapists should consider factors impacting attendance and adherence to treatment and explore parental perceptions of their child's SLCN before embarking on an intervention, a foundation for collaborative practice. A possible limitation of this study is that the levels of attrition in our sample led to generally high measured rates of participation, which should be considered in future studies. Future research should explore adherence in treatments with varying doses, with different types of SLCN or interventions and in different settings. WHAT THIS PAPER ADDS: What is already known on the subject It is acknowledged that parent involvement in their child's therapy, such as attending and adhering to recommendations, is important but little is known about the rates of involvement and what factors may be associated with attendance and adherence in SLT. Qualitative research has explored parental involvement suggesting that beliefs about an intervention may be pertinent. Extensive research in other clinical areas suggest multiple and varied factors are influential and further exploration of particular populations and interventions is necessary. What this paper adds to the existing knowledge This study identified rates of parental non-attendance and non-adherence in a cohort of predominantly mothers of children under the age of 5 years. It is the first study to measure parent adherence in SLT and identify factors that are associated parental adherence to SLT recommendations. It adds to the small body of SLT specific research in understanding risk factors for non-attendance. What are the potential or actual clinical implications of this work? This study highlights the need for a speech and language therapist to consider and explore parents' perspectives of their child's SLCN as a part of achieving collaboration with a parent in order to achieve the best outcomes. It provides a foundation for further systematic research into parent involvement with the ultimate aim of enhancing outcomes for children with SLCN.

Parent-Child Interactions May Help to Explain Relations Between Parent Characteristics and Clinically Observed Child Autistic Behaviours.

The importance of supporting parent-child interactions has been noted in the context of prodromal autism, but little consideration has been given to the possible contributing role of parental characteristics, such as psychological distress. This cross-sectional study tested models in which parent-child interaction variables mediated relations between parent characteristics and child autistic behaviour in a sample of families whose infant demonstrated early signs of autism (N = 103). The findings suggest that associations between parent characteristics (psychological distress; aloofness) and child autistic behaviours may be mediated by the child's inattentiveness or negative affect during interactions. These findings have important implications in developing and implementing interventions in infancy which target the synchrony of parent-child interaction with the goal to support children's social communication development.

Factors associated with mental health symptoms among UK autistic children and young people and their parents during the COVID-19 pandemic.

LAY ABSTRACT: What is already known about the topic: The COVID-19 pandemic and the associated restrictions impacted all of society. There is emerging evidence showing a range of impacts on autistic children and young people and their families. Further research that looks at how individuals coped during the pandemic while considering how they were doing before the pandemic is needed.What this paper adds: This article explores whether how well autistic youth were doing before the pandemic influenced how they coped during the pandemic. It also looked at how well their parents were doing during the pandemic and whether any pre-pandemic factors influenced how they coped. Samples of both primary-school-aged autistic children and autistic teenagers and their parents were surveyed to answer these questions. More engagement and enjoyment in education provision during the pandemic and getting outside more were linked with better child and parental mental health during the pandemic. More attention deficit hyperactivity disorder before the pandemic was linked with more attention deficit hyperactivity disorder and behavioural problems during the pandemic in primary-school-aged autistic children, and more emotional problems during the pandemic in autistic teenagers. Parents with more mental health problems during the pandemic had more mental health problems before the pandemic.Implications for practice, research or policy: Encouraging engagement and enjoyment in education and promoting physical exercise are key intervention targets. Ensuring access to attention deficit hyperactivity disorder medication and support is important, especially if this is managed jointly across school and home.

The Utility of Natural Language Samples for Assessing Communication and Language in Infants Referred with Early Signs of Autism.

Natural Language Sampling (NLS) offers clear potential for communication and language assessment, where other data might be difficult to interpret. We leveraged existing primary data for 18-month-olds showing early signs of autism, to examine the reliability and concurrent construct validity of NLS-derived measures coded from video-of child language, parent linguistic input, and dyadic balance of communicative interaction-against standardised assessment scores. Using Systematic Analysis of Language Transcripts (SALT) software and coding conventions, masked coders achieved good-to-excellent inter-rater agreement across all measures. Associations across concurrent measures of analogous constructs suggested strong validity of NLS applied to 6-min video clips. NLS offers benefits of feasibility and adaptability for validly quantifying emerging skills, and potential for standardisation for clinical use and rigorous research design.

Effects of a Parenting Intervention for Emotional and Behavioral Problems in Young Autistic Children Under Conditions of Enhanced Uncertainty: Two-Year Follow-up of a Pilot Randomized Controlled Trial Cohort (ASTAR) During the United Kingdom COVID-19 Pandemic.

OBJECTIVE: Most young autistic children display emotional and behavioral problems (EBPs). There is evidence that behavioral parenting interventions (BPIs) reduce these. The COVID-19 pandemic and associated lockdowns can be seen as a natural experiment to test the longer-term effect of BPIs under conditions of increased uncertainty. METHOD: Opportunistic follow-up (n = 49) of a pilot randomized controlled trial (RCT) cohort (n = 62 autistic children aged 6-11 years; originally randomized to a 12-week group BPI [Predictive Parenting; n = 31] or an attention control [Psychoeducation; n = 31]) was conducted during COVID-19-related lockdowns. Measures of parent-reported child irritability and parenting stress were collected at 3 time points (baseline: mean age = 6.7 years; primary endpoint: mean age = 7.1 years, ∼5 months after randomization; and COVID-19 follow-up: mean age = 8.8 years, ∼2 years after randomization). We tested the magnitude of intervention effects using point estimates of differences in child irritability and parenting stress between arms at primary endpoint and COVID-19 follow-up, covarying for baseline scores. We used area under the curve (AUC) analyses to obtain overall estimates of the average intervention effect across all 3 timepoints. Semi-structured qualitative interviews were conducted with a subsample of parents (n = 18). RESULTS: A small but significant intervention effect was found from baseline to COVID-19 follow-up in favor of Predictive Parenting on parent-reported child irritability (d = -0.33, 95% CI = -0.65, -0.01) and parenting stress (d = -0.31, 95% CI = -0.59, -0.03). No overall mean intervention effect for these measures as estimated by the AUC analyses (which takes into account the nonsignificant effect at primary endpoint) was found. Interview feedback on the both interventions was positive, and parents reported using strategies from Predictive Parenting during COVID-19-related restrictions. CONCLUSION: This opportunistic follow-up study at a time of stress indicates the need for careful consideration of how and when to measure the effects of BPIs in autistic child populations. Future trials should consider both the most appropriate endpoint and in what context effects may be more likely to be seen. CLINICAL TRIAL REGISTRATION INFORMATION: Autism Spectrum Treatment and Resilience (ASTAR); https://www.isrctn.com; 91411078.

Parent, Teacher and Observational Reports of Emotional and Behavioral Problems in Young Autistic Children.

Emotional and behavioral problems (EBPs) frequently occur in young autistic children. Discrepancies between parents and other informants are common but can lead to uncertainty in formulation, diagnosis and care planning. This study aimed to explore child and informant characteristics are associated with reported child EBPs across settings. Participants were 83 4-8-year-old autistic children and their parents and teachers in the Autism Spectrum Treatment and Resilience (ASTAR) study. Questionnaires of child EBPs were completed by parents and teachers, and self-reported parenting stress and wellbeing measures were obtained. An observation of parent-child/researcher-child interaction was also completed. Parents reported more EBPs than teachers and parent-teacher agreement was low, particularly for emotional problems. Greater parenting stress and being verbal was associated with more parent- but not teacher-reported EBPs. More observed behaviors that challenge were displayed by minimally verbal children. More parenting stress could be associated with the presence of more EBPs in the home; alternatively, parenting stress may confound reports. It is essential for assessments of EBPs in autistic children to take a multi-informant approach. Better understanding of the associations between informant characteristics and informant discrepancies of EBPs is needed.

Using implementation science frameworks to explore barriers and facilitators for parents' use of therapeutic strategies following a parent-mediated autism intervention.

LAY ABSTRACT: Many early autism interventions teach parents therapeutic strategies to help them adjust their communication style with their children. Research has shown that this behaviour change in parents leads to improvements in child communication. It is, therefore, important to learn what factors support or hinder parents in their use of therapeutic strategies learned in such interventions. This study set out to interview parents who had participated in a research trial of the Paediatric Autism Communication Therapy-Generalised intervention. We interviewed 27 caregivers and explored their use of the strategies up to 2 years after the end of the research trial. Qualitative frameworks were used to inform interview questions and data analysis. These frameworks focused on a range of contextual factors, including parents' characteristics, their context and features of the intervention. Parents reported barriers and facilitators to using Paediatric Autism Communication Therapy-Generalised strategies across three themes: Motivating Factors; Opportunity and Support; Parent Characteristics. One of these themes, Motivating Factors, was further divided into the subthemes Compatibility and Buy-In and Alignment of Goals and Outcomes. Almost all parents reported continued use of the Paediatric Autism Communication Therapy-Generalised strategies. Facilitators included parental confidence in using the strategies and barriers included child's behaviour. Consideration of these factors can inform ways to better support parents in future autism interventions.

Caregiver sensitivity predicts infant language use, and infant language complexity predicts caregiver language complexity, in the context of possible emerging autism.

While theory supports bidirectional effects between caregiver sensitivity and language use, and infant language acquisition-both caregiver-to-infant and also infant-to-caregiver effects-empirical research has chiefly explored the former unidirectional path. In the context of infants showing early signs of autism, we investigated prospective bidirectional associations with 6-min free-play interaction samples collected for 103 caregivers and their infants (mean age 12-months; and followed up 6-months later). We anticipated that measures of caregiver sensitivity/language input and infant language would show within-domain temporal stability/continuity, but also that there would be predictive associations from earlier caregiver input to subsequent child language, and vice versa. Caregiver sensitive responsiveness (from the Manchester Assessment of Caregiver-Infant interaction [MACI]) predicted subsequent infant word tokens (i.e., amount of language, coded following the Systematic Analysis of Language Transcripts [SALT]). Further, earlier infant Mean Length of Utterance (MLU; reflecting language complexity, also derived from SALT coding) predicted later caregiver MLU, even when controlling for variability in infant ages and clear within-domain temporal stability/continuity in key measures (i.e., caregiver sensitive responsiveness and infant word tokens; and infant and caregiver MLU). These data add empirical support to theorization on how caregiver input can be both supportive of, and potentially influenced by, infant capacities, when infants have social-communication differences and/or communication/language delays suggestive of possible emerging autism.

Combined social communication therapy at home and in education for young autistic children in England (PACT-G): a parallel, single-blind, randomised controlled trial.

BACKGROUND: Autistic children can have difficulty generalising treatment effects beyond the immediate treatment context. Paediatric Autism Communication Therapy (PACT) has been successful when delivered in the clinic. Here we tested the Paediatric Autism Communication Therapy-Generalised (PACT-G) intervention combined between home and education settings for its overall effect and mechanistic transmission of effect across contexts. METHODS: In this parallel, single-blind, randomised, controlled trial, we recruited autistic children aged 2-11 years in urban or semi-urban areas in Manchester, Newcastle, and London, England. Children needed to meet core autism criteria on Autism Diagnostic Observation Schedule-second edition (ADOS-2) and parent-rated Social Communication Questionnaire (SCQ-lifetime), and children older than 5 years were included if they had intentional communication but expressive language equivalent of age 4 years or younger. Eligible children were randomly assigned (1:1), using block randomisation (random block sizes of 2 and 4) and stratified for site, age (2-4 years vs 5-11 years), and gender, to either PACT-G plus treatment as usual or treatment as usual alone. Research assessors were masked to treatment allocation. The PACT-G intervention was delivered by a therapist in parallel to the child's parents at home and to learning-support assistants (LSA) at their place of education, using both in-person and remote sessions over a 6 month period, to optimise adult-child social interaction. Treatment as usual included any health support or intervention from education or local community services. The primary outcome was autism symptom severity using the ADOS-2, as measured by researchers, at 12 months versus baseline. Secondary outcomes were Brief Observation of Social Communication Change (BOSCC) and dyadic social interaction between child and adult across contexts, both at 12 months. Other secondary outcome measures were assessed using the following composites: language, anxiety, repetitive behaviour, adaptive behaviour, parental wellbeing, child health-related quality of life, and disruptive behaviour. Assessments were done at baseline, 7 months, and 12 months. We used an intention-to-treat (ITT) analysis of covariance for the efficacy outcome measures. Adverse events were assessed by researchers for all trial families at each contact and by therapists in the PACT-G group at each visit. This study is registered with the ISRCTN Registry, ISRCTN 25378536. FINDINGS: Between Jan 18, 2017, and April 19, 2018, 555 children were referred and 249 were eligible, agreed to participate, and were randomly assigned to either PACT-G (n=122) or treatment as usual (n=127). One child in the PACT-G group withdrew and requested their data be removed from the study, giving an ITT population of 248 children. 51 (21%) of 248 children were female, 197 (79%) were male, 149 (60%) were White, and the mean age was 4·0 years (SD 0·6). The groups were well balanced for demographic and clinical characteristics. In the PACT-G group, parents of children received a median of 10 (IQR 8-12) home sessions and LSAs received a median of 8 (IQR 5-10) education sessions over 6 months. We found no treatment effect on the ADOS-2 primary outcome compared with treatment as usual (effect size 0·04 [95% CI -0·19 to 0·26]; p=0·74), or researcher-assessed BOSCC (0·03 [-0·25 to 0·31]), language composite (-0·03 [-0·15 to 0·10]), repetitive behaviour composite (0·00 [-0·35 to 0·35]), adaptive behaviour composite (0·01 [-0·15 to 0·18]), or child wellbeing (0·09 [-0·15 to 0·34]). PACT-G treatment improved synchronous response in both parent (0·50 [0·36 to 0·65]) and LSA (0·33 [0·16 to 0·50]), mediating increased child communication with parent (0·26 [0·12 to 0·40]) and LSA (0·20 [0·06 to 0·34]). Child dyadic communication change mediated outcome symptom alteration on BOSCC at home (indirect effect -0·78 [SE 0·34; 95% CI -1·44 to -0·11]; p=0·022) although not in education (indirect effect -0·67 [SE 0·37; 95% CI -1·40 to 0·06]; p=0·073); such an effect was not seen on ADOS-2. Treatment with PACT-G also improved the parental wellbeing composite (0·44 [0·08 to 0·79]) and the child disruptive behaviour composite in home and education (0·29 [0·01 to 0·57]). Adverse events on child behaviour and wellbeing were recorded in 13 (10%) of 127 children in the treatment as usual group (of whom four [31%] were girls) and 11 (9%) of 122 in the PACT-G group (of whom three [33%] were girls). One serious adverse event on parental mental health was recorded in the PACT-G group and was possibly study related. INTERPRETATION: Although we found no effect on the primary outcome compared with treatment as usual, adaptation of the 12-month PACT intervention into briefer multicomponent delivery across home and education preserved the positive proximal outcomes, although smaller in effect size, and the original pattern of treatment mediation seen in clinic-delivered therapy, as well as improving parental wellbeing and child disruptive behaviours across home and school. Reasons for this reduced efficacy might be the reduced dose of each component, the effect of remote delivery, and the challenges of the delivery contexts. Caution is needed in assuming that changing delivery methods and context will preserve an original intervention efficacy for autistic children. FUNDING: National Institute for Health Research and Medical Research Council Efficacy and Mechanism Evaluation Award.

Effect of Preemptive Intervention on Developmental Outcomes Among Infants Showing Early Signs of Autism: A Randomized Clinical Trial of Outcomes to Diagnosis.

Importance: Intervention for individuals with autism spectrum disorder (ASD) typically commences after diagnosis. No trial of an intervention administered to infants before diagnosis has shown an effect on diagnostic outcomes to date. Objective: To determine the efficacy of a preemptive intervention for ASD beginning during the prodromal period. Design, Setting, and Participants: This 2-site, single rater-blinded randomized clinical trial of a preemptive intervention vs usual care was conducted at 2 Australian research centers (Perth, Melbourne). Community sampling was used to recruit 104 infants aged 9 to 14 months showing early behaviors associated with later ASD, as measured by the Social Attention and Communication Surveillance-Revised. Recruitment occurred from June 9, 2016, to March 30, 2018. Final follow-up data were collected on April 15, 2020. Interventions: Infants were randomized on a 1:1 ratio to receive either a preemptive intervention plus usual care or usual care only over a 5-month period. The preemptive intervention group received a 10-session social communication intervention, iBASIS-Video Interaction to Promote Positive Parenting (iBASIS-VIPP). Usual care comprised services delivered by community clinicians. Main Outcomes and Measures: Infants were assessed at baseline (approximate age, 12 months), treatment end point (approximate age, 18 months), age 2 years, and age 3 years. Primary outcome was the combined blinded measure of ASD behavior severity (the Autism Observation Scale for Infants and the Autism Diagnostic Observation Schedule, second edition) across the 4 assessment points. Secondary outcomes were an independent blinded clinical ASD diagnosis at age 3 years and measures of child development. Analyses were preregistered and comprised 1-tailed tests with an α level of .05. Results: Of 171 infants assessed for eligibility, 104 were randomized; 50 infants (mean [SD] chronological age, 12.40 [1.93] months; 38 boys [76.0%]) received the iBASIS-VIPP preemptive intervention plus usual care (1 infant was excluded after randomization), and 53 infants (mean [SD] age, 12.38 [2.02] months; 32 boys [60.4%]) received usual care only. A total of 89 participants (45 in the iBASIS-VIPP group and 44 in the usual care group) were reassessed at age 3 years. The iBASIS-VIPP intervention led to a reduction in ASD symptom severity (area between curves, -5.53; 95% CI, -∞ to -0.28; P = .04). Reduced odds of ASD classification at age 3 years was found in the iBASIS-VIPP group (3 of 45 participants [6.7%]) vs the usual care group (9 of 44 participants [20.5%]; odds ratio, 0.18; 95% CI, 0-0.68; P = .02). Number needed to treat to reduce ASD classification was 7.2 participants. Improvements in caregiver responsiveness and language outcomes were also observed in the iBASIS-VIPP group. Conclusions and Relevance: Receipt of a preemptive intervention for ASD from age 9 months among a sample of infants showing early signs of ASD led to reduced ASD symptom severity across early childhood and reduced the odds of an ASD diagnosis at age 3 years. Trial Registration: http://anzctr.org.au identifier: ACTRN12616000819426.

Caregiver Psychological Distress Predicts Temperament and Social-Emotional Outcomes in Infants with Autism Traits.

Child temperament and caregiver psychological distress have been independently associated with social-emotional difficulties among individuals with autism. However, the interrelationship among these risk factors has rarely been investigated. We explored the reciprocal interplay between child temperament (surgency, negative affectivity, and self-regulation) and caregiver psychological distress in the development of child internalizing and externalizing symptoms, in a cohort of 103 infants showing early autism traits. Caregivers completed questionnaires when children were aged around 12-months (Time 1 [T1]), 18-months (Time 2 [T2]), and 24-months (Time 3 [T3]). Cross-lagged path models revealed a significant pathway from T1 caregiver psychological distress through lower T2 child self-regulation to subsequently greater T3 child internalizing symptoms. No such caregiver-driven pathway was evident through T2 child negative affectivity or in the prediction of T3 child externalizing symptoms. Further, no support was found for temperament-driven pathways through caregiver psychological distress to child social-emotional difficulties. Child surgency was mostly unrelated to caregiver psychological distress and social-emotional difficulties. These findings implicate the need to support the mental health of caregivers with an infant with autism traits in order to enhance the emotion regulation and social-emotional development of their infants.

A Novel Group Parenting Intervention for Emotional and Behavioral Difficulties in Young Autistic Children: Autism Spectrum Treatment and Resilience (ASTAR): A Randomized Controlled Trial.

OBJECTIVE: To examine the feasibility and preliminary efficacy of a group behavioral parenting intervention for emotional and behavioral problems (EBPs) in young autistic children. METHOD: This was a feasibility pilot randomized controlled trial comparing a 12-week group behavioral parenting intervention (Predictive Parenting) to an attention control (Psychoeducation). Parents of 62 autistic children 4 to 8 years of age were randomized to Predictive Parenting (n = 31) or Psychoeducation (n = 31). The primary outcome was a blinded observational measure of child behaviors that challenge. Secondary outcomes were observed child compliance and parenting behaviors; parent- and teacher-reported child EBPs; self-reported parenting practices, stress, self-efficacy, and well-being. Cost-effectiveness was also explored. RESULTS: Recruitment, retention, completion of measures, treatment fidelity, and parental satisfaction were high for both interventions. There was no group difference in primary outcome: mean log of rate 0.18 lower (d, 90% CI = -0.44 to 0.08) in Predictive Parenting. Differences in rates of child compliance (0.44, 90% CI = 0.11 to 0.77), facilitative parenting (0.63, 90% CI = 0.33 to 0.92) and parent-defined target symptom change (-0.59, 90% CI -0.17 to -1.00) favored Predictive Parenting. There were no differences on other measures. Predictive Parenting was more expensive than Psychoeducation, with a low probability of being more cost-effective. CONCLUSION: Feasibility was demonstrated. There was no evidence from this pilot trial that Predictive Parenting resulted in reductions in child EBPs beyond those seen following Psychoeducation; in addition, the effect size was small, and it was more expensive. However, it showed superiority for child compliance and facilitative parenting with moderate effect sizes. Future, definitive studies should evaluate whether augmented or extended intervention would lead to larger improvements. CLINICAL TRIAL REGISTRATION INFORMATION: Autism Spectrum Treatment and Resilience (ASTAR); https://www.isrctn.com/; 91411078.

Introducing 'Predictive Parenting': A Feasibility Study of a New Group Parenting Intervention Targeting Emotional and Behavioral Difficulties in Children with Autism Spectrum Disorder.

Parent-mediated interventions can reduce behavioral and emotional problems in children with ASD. This report discusses the development of the first group parent intervention targeting behaviors and anxiety in children with ASD, across the spectrum of cognitive and language ability. 'Predictive Parenting' was developed from the clinical observation (and emerging evidence base) that children with ASD struggle with 'prediction' and anticipating change. It integrates well-established parenting strategies within an ASD-specific framework. The concept was co-created with patient and public involvement panels of parents and adults with ASD. A feasibility study found the programme is acceptable and accessible. Qualitative feedback from participants was largely positive, and critiques were used to inform a larger, pilot randomized controlled trial of the intervention.

Development of the Observation Schedule for Children with Autism-Anxiety, Behaviour and Parenting (OSCA-ABP): A New Measure of Child and Parenting Behavior for Use with Young Autistic Children.

Co-occurring emotional and behavioral problems (EBPs) frequently exist in young autistic children. There is evidence based on parental report that parenting interventions reduce child EBPs. More objective measures of child EBPs should supplement parent reported outcomes in trials. We describe the development of a new measure of child and parenting behavior, the Observation Schedule for Children with Autism-Anxiety, Behaviour and Parenting (OSCA-ABP). Participants were 83 parents/carers and their 4-8-year-old autistic children. The measure demonstrated good variance and potential sensitivity to change. Child and parenting behavior were reliably coded among verbal and minimally verbal children. Associations between reports from other informants and observed behavior showed the measure had sufficient convergent validity. The measure has promise to contribute to research and clinical practice in autism mental health beyond objective measurement in trials.

The Role of Negative Affectivity in Concurrent Relations Between Caregiver Psychological Distress and Social-Emotional Difficulties in Infants With Early Signs of Autism.

Recent evidence suggests the link between caregiver psychological distress and offspring social-emotional difficulties may be accounted for by offspring temperament characteristics. However, existing studies have only focused on neurotypical children; thus, the current study sought to provide an initial examination of this process among children with varying levels of early autism features. Participants included 103 infants aged 9-16 months (M = 12.39, SD = 1.97; 68% male) and their primary caregiver (96% mothers) referred to a larger study by community healthcare professionals. We utilized caregiver-reported measures of psychological distress (Depression Anxiety Stress Scales), infant temperament (Infant Behavior Questionnaire-Revised) and internalizing and externalizing symptoms (Infant-Toddler Social and Emotional Assessment) and administered the Autism Observation Schedule for Infants (AOSI) at an assessment visit to quantify autism features. Infant negative affectivity was found to mediate positive concurrent relations between caregiver psychological distress and infant internalizing and externalizing symptoms, irrespective of the infants' AOSI score. While preliminary and cross-sectional, these results replicate and extend previous findings suggesting that the pathway from caregiver psychological distress to negative affectivity to social-emotional difficulties might also be apparent among infants with varying levels of autism features. More rigorous tests of causal effects await future longitudinal investigation. LAY SUMMARY: Offspring of caregivers experiencing psychological distress (i.e., symptoms of depression, anxiety, and/or stress) may themselves be at increased risk of poor mental health outcomes. Several previous studies conducted with neurotypical children suggest that this link from caregiver-to-child may be facilitated by children's temperament qualities. This study was a preliminary cross-sectional exploration of these relationships in infants with features of autism. We found that infants' elevated negative emotions were involved in the relation between caregiver heightened psychological distress and children's mental health difficulties, consistent with neurotypical development. Autism Res 2020, 13: 1349-1357. © 2020 International Society for Autism Research, Wiley Periodicals, Inc.

Clinical and cost effectiveness of a parent mediated intervention to reduce challenging behaviour in pre-schoolers with moderate to severe intellectual disability (EPICC-ID) study protocol: a multi-centre, parallel-group randomised controlled trial.

BACKGROUND: Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities. METHODS: This trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30-59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual, whilst the Treatment as Usual only group receive other available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data will also be collected to carry out a cost effectiveness and utility evaluation. DISCUSSION: Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov, NCT03086876. Registered 22nd March 2017, https://clinicaltrials.gov/ct2/show/NCT03086876.

Beyond intervention into daily life: A systematic review of generalisation following social communication interventions for young children with autism.

Researchers have generally considered autistic individuals to have difficulties generalising learned skills across novel contexts. Successful generalisation is necessary for an intervention to have benefits in everyday life beyond the original learning environment. We conducted a systematic review of randomised controlled trials of early social communication interventions for children with autism in order to explore generalisation and its measurement. We identified nine RCTs that provided evidence of initial target learning and measured generalisation, of which eight demonstrated at least some successful generalisation across people, settings, and/or activities. The findings did not support the widely reported generalisation 'difficulties' associated with autism. However, generalisation was not consistent across all skills within studies, and one study found no generalisation despite evidence for initial target learning within the intervention context. In general, there are few methodologically sound social communication intervention studies exploring generalisation in autism and no consensus on how it should be measured. In particular, failure to demonstrate initial learning of target skills within the intervention setting and an absence of formal mediation analyses of the hypothesised mechanisms limit current research. We outline a framework within which measurement of generalisation can be considered for use in future trials. To maximise the effectiveness of interventions, the field needs to gain a better understanding of the nature of generalisation among autistic individuals and what additional strategies may further enhance learning. Autism Res 2020, 13: 506-522. © 2020 The Authors. Autism Research published by International Society for Autism Research published by Wiley Periodicals, Inc. LAY SUMMARY: It is generally considered that autistic individuals experience difficulties applying things they have learned in one context into different settings (e.g. from school to home). This is important to consider for intervention studies. Our review does not support a complete lack of generalisation but instead suggests that after early social communication intervention, autistic children can transfer some skills to new contexts. Overall, there is limited research in this area and further work is needed.