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.

Using a theory-based, customized video game as an educational tool to improve physicians' trauma triage decisions: study protocol for a randomized cluster trial.

BACKGROUND: Transfer of severely injured patients to trauma centers, either directly from the field or after evaluation at non-trauma centers, reduces preventable morbidity and mortality. Failure to transfer these patients appropriately (i.e., under-triage) remains common, and occurs in part because physicians at non-trauma centers make diagnostic errors when evaluating the severity of patients' injuries. We developed Night Shift, a theory-based adventure video game, to recalibrate physician heuristics (intuitive judgments) in trauma triage and established its efficacy in the laboratory. We plan a type 1 hybrid effectiveness-implementation trial to determine whether the game changes physician triage decisions in real-life and hypothesize that it will reduce the proportion of patients under-triaged. METHODS: We will recruit 800 physicians who work in the emergency departments (EDs) of non-trauma centers in the US and will randomize them to the game (intervention) or to usual education and training (control). We will ask those in the intervention group to play Night Shift for 2 h within 2 weeks of enrollment and again for 20 min at quarterly intervals. Those in the control group will receive only usual education (i.e., nothing supplemental). We will then assess physicians' triage practices for older, severely injured adults in the 1-year following enrollment, using Medicare claims, and will compare under-triage (primary outcome), 30-day mortality and re-admissions, functional independence, and over-triage between the two groups. We will evaluate contextual factors influencing reach, adoption, implementation, and maintenance with interviews of a subset of trial participants (n = 20) and of other key decision makers (e.g., patients, first responders, administrators [n = 100]). DISCUSSION: The results of the trial will inform future efforts to improve the implementation of clinical practice guidelines in trauma triage and will provide deeper understanding of effective strategies to reduce diagnostic errors during time-sensitive decision making. TRIAL REGISTRATION: ClinicalTrials.gov; NCT06063434 . Registered 26 September 2023.

Mind-mindedness and preschool children's behavioral difficulties: The moderating role of maternal parenting distress.

Mind-mindedness (MM) is a caregiver's tendency to appreciate their infant's internal mental states. This longitudinal study investigated whether maternal MM (10 months) was linked with children's later behavioral problems (51 months) and the moderating role of maternal parenting distress (PD; 36 months) in a sample of 91 mother-infant dyads. Appropriate MM comments were coded from video-recorded, semi-structured play interactions between mothers and their infants; PD was obtained from maternal completion of the PD subscale of the Parenting Stress Index - Short Form (PSI-SF); and child internalizing and externalizing behavior problems were gathered from maternal report on the Strengths and Difficulties Questionnaire (SDQ). Moderated regression analyses revealed higher early appropriate MM was associated with significantly fewer internalizing emotional problems at 51 months among mothers with lower PD at 36 months, and higher early appropriate MM was associated with lower conduct problems at 51 months in mothers with higher PD at 36 months. Findings demonstrated the importance of considering nuanced contexts such as at-risk mothers and differential presentations of child difficulties in the analysis of the relationship between MM and child behavioral difficulties and the development of MM interventions.

Testing the feasibility, acceptability, and preliminary effect of a novel deliberate practice intervention to reduce diagnostic error in trauma triage: a study protocol for a randomized pilot trial.

BACKGROUND: Non-compliance with clinical practice guidelines in trauma remains common, in part because physicians make diagnostic errors when triaging injured patients. Deliberate practice, purposeful participation in a training task under the oversight of a coach, effectively changes behavior in procedural domains of medicine but has rarely been used to improve diagnostic skill. We plan a pilot parallel randomized trial to test the feasibility, acceptability, and preliminary effect of a novel deliberate practice intervention to reduce physician diagnostic errors in trauma triage. METHODS: We will randomize a national convenience sample of physicians who work at non-trauma centers (n = 60) in a 1:1 ratio to a deliberate practice intervention or to a passive control. We will use a customized, theory-based serious video game as the basis of our training task, selected based on its behavior change techniques and game mechanics, along with a coaching manual to standardize the fidelity of the intervention delivery. The intervention consists of three 30-min sessions with content experts (coaches), conducted remotely, during which physicians (trainees) play the game and receive feedback on their diagnostic processes. We will assess (a) the fidelity with which the intervention is delivered by reviewing video recordings of the coaching sessions; (b) the acceptability of the intervention through surveys and semi-structured interviews, and (c) the effect of the intervention by comparing the performance of trainees and a control group of physicians on a validated virtual simulation. We hypothesize that trainees will make ≥ 25% fewer diagnostic errors on the simulation than control physicians, a large effect size. We additionally hypothesize that ≥ 90% of trainees will receive their intervention as planned. CONCLUSIONS: The results of the trial will inform the decision to proceed with a future hybrid effectiveness-implementation trial of the intervention. It will also provide a deeper understanding of the challenges of using deliberate practice to modify the diagnostic skill of physicians. TRIAL REGISTRATION: Clinical trials.gov ( NCT05168579 ); 23 December 2021.

Relative predictive utility of the original and Autism-Specific Five-Minute Speech Samples for child behaviour problems in autistic preschoolers: A preliminary study.

LAY ABSTRACT: Parental Expressed Emotion refers to the intensity and nature of emotion shown when a parent talks about their child, and has been linked to child behaviour outcomes. Parental Expressed Emotion has typically been measured using the Five-Minute Speech Sample; however, the Autism-Specific Five-Minute Speech Sample was developed to better capture Expressed Emotion for parents of children on the autism spectrum. In each case, parents are asked to talk for 5 min about their child and how they get along with their child. Parents' statements are then coded for features such as number of positive and critical comments, or statements reflecting strong emotional involvement. While both the Five-Minute Speech Sample and Autism-Specific Five-Minute Speech Sample have been used with parents of autistic school-aged children, their relative usefulness for measuring Expressed Emotion in parents of preschool-aged children - including their links to child behaviour problems in this group - is unclear. We collected speech samples from 51 parents of newly diagnosed autistic preschoolers to investigate similarities and differences in results from the Five-Minute Speech Sample and Autism-Specific Five-Minute Speech Sample coding schemes. This included exploring the extent to which the Five-Minute Speech Sample and Autism-Specific Five-Minute Speech Sample, separately, or together, predicted current and future child behaviour problems. While the two measures were related, we found only the Autism-Specific Five-Minute Speech Sample - but not the Five-Minute Speech Sample - was related to child behavioural challenges. This adds support to the suggestion that the Autism-Specific Five-Minute Speech Sample may be a more useful measure of parental Expressed Emotion in this group, and provides a first step towards understanding how autistic children might be better supported by targeting parental Expressed Emotion.

Identifying and overcoming barriers to trauma screening in the primary care setting.

Introduction: Underrecognition of trauma exposure and PTSD has a significant impact on psychiatric health, physical health, and health behaviors. The purpose of this study is to explore barriers and opportunities for trauma screening in primary care. Methods: Primary care physicians (PCPs) and their patients were interviewed about the acceptability of trauma screening and brief treatment in primary care. Interview transcripts were coded and analyzed for themes using Atlas v. 7.0. Results: Data showed PCPs informally screen for trauma but were hampered by organizational constraints including time, availability of behavioral health providers, and knowledge of trauma-informed-care practices. Most patients with trauma history met with behavioral health providers during their lifetimes, but still did not believe it was the PCPs' role to address trauma exposure, had fears of "appearing crazy," or were ambivalent about seeking treatment. Discussion: Findings suggest an enormous complexity involved in screening for trauma in primary care service delivery. Trauma screening appears to work best within the course of relationship building where patients can begin to see that their physician is capable of playing an important role in managing trauma, depression, and PTSD symptoms. We address how trauma discussion can take place within existing trauma informed care guidelines. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Depression prevalence based on the Edinburgh Postnatal Depression Scale compared to Structured Clinical Interview for DSM DIsorders classification: Systematic review and individual participant data meta-analysis.

OBJECTIVES: Estimates of depression prevalence in pregnancy and postpartum are based on the Edinburgh Postnatal Depression Scale (EPDS) more than on any other method. We aimed to determine if any EPDS cutoff can accurately and consistently estimate depression prevalence in individual studies. METHODS: We analyzed datasets that compared EPDS scores to Structured Clinical Interview for DSM (SCID) major depression status. Random-effects meta-analysis was used to compare prevalence with EPDS cutoffs versus the SCID. RESULTS: Seven thousand three hundred and fifteen participants (1017 SCID major depression) from 29 primary studies were included. For EPDS cutoffs used to estimate prevalence in recent studies (≥9 to ≥14), pooled prevalence estimates ranged from 27.8% (95% CI: 22.0%-34.5%) for EPDS ≥ 9 to 9.0% (95% CI: 6.8%-11.9%) for EPDS ≥ 14; pooled SCID major depression prevalence was 9.0% (95% CI: 6.5%-12.3%). EPDS ≥14 provided pooled prevalence closest to SCID-based prevalence but differed from SCID prevalence in individual studies by a mean absolute difference of 5.1% (95% prediction interval: -13.7%, 12.3%). CONCLUSION: EPDS ≥14 approximated SCID-based prevalence overall, but considerable heterogeneity in individual studies is a barrier to using it for prevalence estimation.

Overestimation of Postpartum Depression Prevalence Based on a 5-item Version of the EPDS: Systematic Review and Individual Participant Data Meta-analysis.

OBJECTIVE: The Maternal Mental Health in Canada, 2018/2019, survey reported that 18% of 7,085 mothers who recently gave birth reported "feelings consistent with postpartum depression" based on scores ≥7 on a 5-item version of the Edinburgh Postpartum Depression Scale (EPDS-5). The EPDS-5 was designed as a screening questionnaire, not to classify disorders or estimate prevalence; the extent to which EPDS-5 results reflect depression prevalence is unknown. We investigated EPDS-5 ≥7 performance relative to major depression prevalence based on a validated diagnostic interview, the Structured Clinical Interview for DSM (SCID). METHODS: We searched Medline, Medline In-Process & Other Non-Indexed Citations, PsycINFO, and the Web of Science Core Collection through June 2016 for studies with data sets with item response data to calculate EPDS-5 scores and that used the SCID to ascertain depression status. We conducted an individual participant data meta-analysis to estimate pooled percentage of EPDS-5 ≥7, pooled SCID major depression prevalence, and the pooled difference in prevalence. RESULTS: A total of 3,958 participants from 19 primary studies were included. Pooled prevalence of SCID major depression was 9.2% (95% confidence interval [CI] 6.0% to 13.7%), pooled percentage of participants with EPDS-5 ≥7 was 16.2% (95% CI 10.7% to 23.8%), and pooled difference was 8.0% (95% CI 2.9% to 13.2%). In the 19 included studies, mean and median ratios of EPDS-5 to SCID prevalence were 2.1 and 1.4 times. CONCLUSIONS: Prevalence estimated based on EPDS-5 ≥7 appears to be substantially higher than the prevalence of major depression. Validated diagnostic interviews should be used to establish prevalence.

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.

Effectiveness of the Volunteer Family Connect Program in Reducing Isolation of Vulnerable Families and Supporting Their Parenting: Randomized Controlled Trial With Intention-To-Treat Analysis of Primary Outcome Variables.

BACKGROUND: Volunteer home visiting is a widely adopted community-based approach to support families by linking isolated or vulnerable families with community volunteers who visit their homes weekly over approximately 12 months. This study seeks to robustly evaluate the effectiveness of this model of support for families with young children. OBJECTIVE: This paper reports the intention-to-treat analysis of primary and secondary outcomes for a pragmatic randomized controlled trial (RCT) of the Volunteer Family Connect intervention, a volunteer home-visiting program designed to support families with young children who experience social isolation or a lack of parenting confidence and skills. METHODS: The RCT was conducted across seven sites in Australia. Overall, 341 families were recruited: 169 intervention (services as usual+volunteer home visits) and 172 control (services as usual) families. Intervention families received the program for 3-12 months. Participants were invited to complete six data collection points over a 15-month period. Primary outcomes were community connectedness and parenting competence. Secondary outcomes included parent physical and mental health, general parent wellbeing, parent empowerment, the sustainability of family routines, and the parent-child relationship. According to the protocol, the program would be judged to be effective if at least one of the primary outcomes was significantly positive and the other was neutral (ie, intervention families did not demonstrate positive or negative outcomes compared to the control group). RESULTS: The intervention group demonstrated significant improvement in the primary outcome variable parenting sense of competence as compared to the control group. Overall, there was no significant difference between the intervention and control groups with regard to the primary outcome variable community connectedness, other than on the "Guidance" subscale of the Social Provisions Scale. Because there were statistically significant findings for the total score of one primary outcome variable "parenting sense of competence" and largely neutral findings for the primary outcome variable "community connectedness," the program met the previously defined criteria for program effectiveness. In relation to secondary outcomes, intervention families reported significantly higher wellbeing and were significantly more likely to feel that life was improving. CONCLUSIONS: The Volunteer Family Connect intervention was considered an effective intervention, with a role to play on the landscape of services available to support vulnerable families with young children. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12616000396426; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370304.

Comparison of major depression diagnostic classification probability using the SCID, CIDI, and MINI diagnostic interviews among women in pregnancy or postpartum: An individual participant data meta-analysis.

OBJECTIVES: A previous individual participant data meta-analysis (IPDMA) identified differences in major depression classification rates between different diagnostic interviews, controlling for depressive symptoms on the basis of the Patient Health Questionnaire-9. We aimed to determine whether similar results would be seen in a different population, using studies that administered the Edinburgh Postnatal Depression Scale (EPDS) in pregnancy or postpartum. METHODS: Data accrued for an EPDS diagnostic accuracy IPDMA were analysed. Binomial generalised linear mixed models were fit to compare depression classification odds for the Mini International Neuropsychiatric Interview (MINI), Composite International Diagnostic Interview (CIDI), and Structured Clinical Interview for DSM (SCID), controlling for EPDS scores and participant characteristics. RESULTS: Among fully structured interviews, the MINI (15 studies, 2,532 participants, 342 major depression cases) classified depression more often than the CIDI (3 studies, 2,948 participants, 194 major depression cases; adjusted odds ratio [aOR] = 3.72, 95% confidence interval [CI] [1.21, 11.43]). Compared with the semistructured SCID (28 studies, 7,403 participants, 1,027 major depression cases), odds with the CIDI (interaction aOR = 0.88, 95% CI [0.85, 0.92]) and MINI (interaction aOR = 0.95, 95% CI [0.92, 0.99]) increased less as EPDS scores increased. CONCLUSION: Different interviews may not classify major depression equivalently.

Factors Associated With Receipt of Cognitive-Behavioral Therapy or Prolonged Exposure Therapy Among Individuals With PTSD.

OBJECTIVE: The aim of this study was to systematically review variables associated with initiation of trauma-centered cognitive-behavioral therapy (TC-CBT) among individuals with posttraumatic stress disorder (PTSD). METHODS: PubMed, PsycINFO, Web of Science, Published International Literature on Traumatic Stress (PILOTS), and Scopus were searched in a systematic manner up to 2018, and 26 relevant studies were recovered and analyzed. RESULTS: The average weighted initiation rate was 6% in larger hospital systems with a high rate of trauma and 28% in outpatient mental health settings (range 4%-83%). Older age (odds ratio [OR]=1.56, 95% confidence interval [CI]=0.51-1.61), female gender (OR=1.18, 95% CI=1.08-1.27), black or other racial-ethnic minority group (OR=1.16, 95% CI=1.03-1.28), Veterans Affairs PTSD service connection status (OR=2.30, 95% CI=2.18-2.42), mental health referral (OR=2.28, 95% CI=1.05-3.50), greater staff exposure to TC-CBT (OR=2.30, 95% CI=2.09-2.52), adaptability of TC-CBT to staff workflow (OR=4.66, 95% CI=1.60-7.72), greater PTSD severity (OR=1.46, 95% CI=1.13-1.78), and comorbid depression (OR=1.21, 95% CI=1.14-1.29) increased the likelihood of TC-CBT initiation, whereas delayed treatment reduced the likelihood of TC-CBT initiation (OR=0.93, 95% CI=0.92-0.95). Qualitative studies showed that mental health beliefs (stigma and lack of readiness), provider organizational factors (low availability, privacy issues), and patient lack of time (logistics) were perceived as barriers to initiation by patients and providers. CONCLUSIONS: TC-CBT initiation increased among patients who were older and female. Initiation was also higher among providers who had more exposure to TC-CBT in their work environment and when TC-CBT fit into their existing workflow.

Community Volunteer Support for Families With Young Children: Protocol for the Volunteer Family Connect Randomized Controlled Trial.

BACKGROUND: Use of community volunteers to support vulnerable families is a widely employed strategy with a long history. However, there has been minimal formal scientific investigation into the effectiveness of volunteer home visiting programs for families. There is also a need for research examining whether volunteer home visiting leads to improved outcomes for volunteers. OBJECTIVE: The objective of this paper is to describe the research protocol for a pragmatic randomized controlled trial (RCT) of the Volunteer Family Connect intervention, a volunteer home visiting program designed to support families of young children who experience social isolation or a lack of parenting confidence and skills. The project is being conducted in partnership with 3 leading not-for-profit organizations, designed to contribute to the body of evidence that informs decisions about appropriate family support services according to the level of need. It is the first study to examine outcomes for both the families and the volunteers who deliver the service. METHODS: The RCT is being conducted in 7 sites across Australia. We aim to recruit 300 families to the study: 150 control (services as usual) and 150 intervention (services as usual + volunteer home visiting) families. Intervention families will receive the service for 3-12 months according to their needs, and all participants will complete 6 data collection points over 15 months. A minimum of 80 volunteers will also be recruited, along with a matched community comparison group. The volunteers will complete 3 data collection points over 12 months. Primary outcomes include community connectedness and parenting competence. Secondary outcomes include parent physical and mental health; general parent well-being; parent empowerment; the child-parent relationship; sustainability of family routines; child immunization; child nutrition or breastfeeding; number of accidental injury reports; and volunteer health, well-being, and community connectedness. RESULTS: This effectiveness trial was funded in 2016, and we aim to complete data collection by the end of 2018. The first results are expected to be submitted early in 2019. CONCLUSIONS: There is a need to rigorously assess volunteer home visiting and whether it has a unique and important role on the service landscape, complementary to professional services. This research is the first trial of a volunteer home visiting program to be conducted in Australia and one of the largest of its kind worldwide. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12616000396426; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370304 (Archived by WebCite athttp://www.webcitation.org/70q42fU7V). REGISTERED REPORT IDENTIFIER: RR1-10.2196/1000.

Randomized controlled trial and economic evaluation of nurse-led group support for young mothers during pregnancy and the first year postpartum versus usual care.

BACKGROUND: Child maltreatment is a significant public health problem. Group Family Nurse Partnership (gFNP) is a new intervention for young, expectant mothers implemented successfully in pilot studies. This study was designed to determine the effectiveness and cost-effectiveness of gFNP in reducing risk factors for maltreatment with a potentially vulnerable population. METHODS: A multi-site, randomized controlled, parallel-arm trial and prospective economic evaluation was conducted, with allocation via remote randomization (minimization by site, maternal age group) to gFNP or usual care. Participants were expectant mothers aged below 20 years with at least one live birth, or aged 20-24 years with no live births and with low educational qualifications. Data from maternal interviews at baseline and when infants were 2, 6 and 12 months, and video-recording at 12 months, were collected by researchers blind to allocation. Cost information came from weekly logs completed by gFNP family nurses and other service delivery data reported by participants. Primary outcomes measured at 12 months were parenting attitudes (Adult-Adolescent Parenting Index, AAPI-2) and maternal sensitivity (CARE Index). The economic evaluation was conducted from a UK NHS and personal social services perspective with cost-effectiveness expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The main analyses were intention-to-treat with additional complier average causal effects (CACE) analyses. RESULTS: Between August 2013 and September 2014, 492 names of potential participants were received of whom 319 were eligible and 166 agreed to take part, 99 randomly assigned to receive gFNP and 67 to usual care. There were no between-arm differences in AAPI-2 total (7 · 5/10 in both, SE 0.1), difference adjusted for baseline, site and maternal age group 0 · 06 (95% CI - 0 · 15 to 0 · 28, p = 0 · 59) or CARE Index (intervention 4 · 0 (SE 0 · 3); control 4 · 7 (SE 0 · 4); difference adjusted for site and maternal age group - 0 · 68 (95% CI - 1 · 62 to 0 · 16, p = 0 · 25) scores. The probability that gFNP is cost-effective based on the QALY measure did not exceed 3%. CONCLUSIONS: The trial did not support gFNP as a means of reducing the risk of child maltreatment in this population but slow recruitment adversely affected group size and consequently delivery of the intervention. TRIAL REGISTRATION: ISRCTN78814904 . Registered on 17 May 2013.

Measurement Issues: Measures of infant mental health.

BACKGROUND: Emotional and behavioural problems emerging in very young children can represent a challenge to the child and family and warrant early identification and appropriate support or intervention. Diagnostic systems are being developed that allow for specific difficulties to be identified and this review summarizes them. SCOPE: This evidenced based review describes the psychometric properties and potential for use in clinical practice of a range of instruments and methods that are available to identify infant mental health difficulties, and which may be suitable for use in primary care settings, including observations, questionnaires and checklists. FINDINGS AND CONCLUSION: While debate continues about whether infant mental health problems can or should be identified, the use of standardized tools may help clinicians to compare observations of infants so that those emerging as atypical can receive additional attention, reflecting a more targeted approach to primary care services.

Understanding barriers to involving community midwives in identifying research participants; experience of the first steps randomised controlled trial.

OBJECTIVE: to explore barriers to the involvement of community midwives in identifying women in early pregnancy as potential participants in the first steps study, a randomised controlled trial of a new intervention to provide health and parenting support to potentially vulnerable women. DESIGN: descriptive qualitative investigation using semi-structured audio-recorded interviews. SETTING: community midwifery offices. PARTICIPANTS: volunteer sample of 13 community midwives. MEASUREMENT: themes derived from content analysis. FINDINGS: understanding of their role in the research process was unclear to many midwives. Confusion arose about the difference between potential participant identification and trial recruitment. There were concerns about the eligibility criteria and it was suggested that there was insufficient time during booking appointments, and sometimes insufficient information, to determine potential eligibility. Midwives had concerns about some aspects of the intervention, which incorporated routine midwifery care, and had expectations that women may not like a group programme. This may have led some not to mention the trial. They were, however positive about the programme׳s potential for beneficial impacts on mothers and infants. KEY CONCLUSIONS: dedicated research midwives may be the best option if research studies need to identify potential participants early in pregnancy, so that they can communicate with all their colleagues. IMPLICATIONS FOR PRACTICE: if community midwives are asked to be involved in time-critical research they are likely to need additional local resources and support.

Paternal Age, Paternal Presence and Children's Health: An Observational Study.

In an observational study of 31,257 children we investigated the effects of paternal age at the time of the child's birth, paternal absence and non-biological fathers on children's health. Results are per 5 year change in paternal age. Older fathers were associated with lower rates of unintentional injuries, odds ratio (OR)=0.966, P=0.0027. There was a quadratic association between paternal age and risk of hospital admission, ß=0.0121, P=0.0109, with minimum risk at paternal age 37.7. Absent fathers were associated with increased risk of hospital admission, OR=1.19, P<10(-3), lower rates of complete immunizations to 9 months, OR=0.562, P<10(-3), higher Strength and Difficulties Questionnaire (SDQ) difficulties scores: ß=0.304, P=0.0024 (3 year olds), ß=0.697, P<10(-3) (5 year olds). Non-biological fathers were associated with increased risk of unintentional injury, OR=1.16, P=0.0319 and hospital admission, OR=1.26, P=0.0166; lower rates of complete immunizations to 9 months, OR=0.343, P=0.0309 and higher SDQ difficulties scores: ß=0.908, P<10(-3).

Health and development of children born after assisted reproductive technology and sub-fertility compared to naturally conceived children: data from a national study.

In a non-matched case-control study using data from two large national cohort studies, we investigated whether indicators of child health and development up to 7 years of age differ between children conceived using assisted reproductive technology (ART), children born after sub-fertility (more than 24 months of trying for conception) and other children. Information on ART use/sub-fertility was available for 23,649 children. There were 227 cases (children conceived through ART) and two control groups: 783 children born to sub-fertile couples, and 22,639 children born to couples with no fertility issues. In models adjusted for social and demographic factors there were significant differences between groups in rate of hospital admissions before the children were 9 months old (P=0.029), with the ART group showing higher rates of hospital admission than the no fertility issues control group, the sub-fertile control group being intermediate between the two. Children born after ART had comparable health and development beyond 9 months of age to their naturally conceived peers. This applied to the whole sample and to a sub-sample of children from deprived neighborhoods.