Childhood Predictors of Healthcare Use and Health Status in Early Adulthood: Findings from the Twins Early Development Study.

The use of healthcare services is likely to be associated with need but also the factors relating to the care system and the ability to negotiate around it. Healthcare use and health status may also be associated with the factors that exist in childhood. This study aims to identify the demographic, clinical, and cognitive characteristics of children at age 4 that impact healthcare use and health status at age 21. The data from the Twins Early Development Study were used. Health problems, healthcare use, and cognitive ability at age 4 were entered into generalised estimating equations to predict the use of general practitioners, outpatient services, counselling, emergency clinic visits, and a healthcare helpline at age 21. Similar models existed for the prediction of whether problems were recorded on the EQ-5D-5L EuroQol instrument. The data on up to 6707 individuals were available for analysis. Sex was a significant predictor of service use, with boys being more likely than girls to later use all services, except for emergency clinic visits. Certain health conditions at age 4 predicted the use of services with models differing according to service type. Greater general cognitive ability predicted higher use of general practitioners, outpatient care, and health helplines. The current health status was strongly predictive of service use. Service use in young adulthood was significantly related to concurrent health status as well as health conditions in childhood. General cognitive ability was significantly associated with the use of general practitioner contacts, outpatient visits, and the use of a health helpline.

Economic threshold analysis of delivering a task-sharing treatment for common mental disorders at scale: the Friendship Bench, Zimbabwe.

BACKGROUND: Task-sharing treatment approaches offer a pragmatic approach to treating common mental disorders in low-income and middle-income countries (LMICs). The Friendship Bench (FB), developed in Zimbabwe with increasing adoption in other LMICs, is one example of this type of treatment model using lay health workers (LHWs) to deliver treatment. OBJECTIVE: To consider the level of treatment coverage required for a recent scale-up of the FB in Zimbabwe to be considered cost-effective. METHODS: A modelling-based deterministic threshold analysis conducted within a 'cost-utility' framework using a recommended cost-effectiveness threshold. FINDINGS: The FB would need to treat an additional 3413 service users (10 per active LHW per year) for its scale-up to be considered cost-effective. This assumes a level of treatment effect observed under clinical trial conditions. The associated incremental cost-effectiveness ratio was $191 per year lived with disability avoided, assuming treatment coverage levels reported during 2020. The required treatment coverage for a cost-effective outcome is within the level of treatment coverage observed during 2020 and remained so even when assuming significantly compromised levels of treatment effect. CONCLUSIONS: The economic case for a scaled-up delivery of the FB appears convincing in principle and its adoption at scale in LMIC settings should be given serious consideration. CLINICAL IMPLICATIONS: Further evidence on the types of scale-up strategies that are likely to offer an effective and cost-effective means of sustaining required levels of treatment coverage will help focus efforts on approaches to scale-up that optimise resources invested in task-sharing programmes.

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.

Cognitive remediation therapy for patients with bipolar disorder: A randomised proof-of-concept trial.

OBJECTIVES: Cognitive remediation therapy (CRT) may benefit people with bipolar disorder type I and II for whom cognitive impairment is a major contributor to disability. Extensive research has demonstrated CRT to improve cognition and psychosocial functioning in people with different diagnoses, but randomised trials of evidenced therapy programmes are lacking for bipolar disorders. The Cognitive Remediation in Bipolar (CRiB) study aimed to determine whether an established CRT programme is feasible and acceptable for people with bipolar disorders. METHODS: This proof-of-concept, single-blind randomised trial recruited participants aged 18-65 with bipolar disorder, not currently experiencing an episode. They were 1:1 block randomised to treatment-as-usual (TAU) with or without individual CRT for 12 weeks. The partly computerised CRT programme ("CIRCuiTS") was therapist-led and is evidence-based from trials in those with psychotic illnesses. Data were collected and analysed by investigators blinded to group allocation. The main outcomes (week 13 and 25) examined participant retention, intervention feasibility and putative effects of CRT on cognitive and psychosocial functioning via intention-to-treat analyses. TRIAL REGISTRATION: ISRCTN ID32290525. RESULTS: Sixty participants were recruited (02/2016-06/2018) and randomised to CRT (n = 29) or TAU (n = 31). Trial withdrawals were equivalent (CRT n = 2/29; TAU n = 5/31). CRT satisfaction indicated high acceptability. Intention-to-treat analyses (N = 60) demonstrated greater improvements for CRT- than TAU-randomised participants: at both week 13 and 25, CIRCuiTS participants showed larger improvements in the following domains (week 25 effect sizes reported here): IQ (SES = 0.71, 95% CI [0.29,1.13]), working memory (SES = 0.70, 95% CI [0.31,1.10]), executive function (SES = 0.93, 95% CI [0.33,1.54]), psychosocial functioning (SES = 0.49, 95% CI [0.18,0.80]) and goal attainment (SES = 2.02, 95% CI [0.89,3.14]). No serious adverse events were reported. CONCLUSIONS: CRT is feasible for individuals with bipolar disorders and may enhance cognition and functioning. The reported effect sizes from this proof-of-concept trial encourage further investigation in a definitive trial.

An intervention for parents with severe personality difficulties whose children have mental health problems: a feasibility RCT.

BACKGROUND: The children of parents with severe personality difficulties have greater risk of significant mental health problems. Existing care is poorly co-ordinated, with limited effectiveness. A specialised parenting intervention may improve child and parenting outcomes, reduce family morbidity and lower the service costs. OBJECTIVES: To develop a specialised parenting intervention for parents affected by severe personality difficulties who have children with mental health problems and to conduct a feasibility trial. DESIGN: A pragmatic, mixed-methods design to develop and pilot a specialised parenting intervention, Helping Families Programme-Modified, and to conduct a randomised feasibility trial with process evaluation. Initial cost-effectiveness was assessed using UK NHS/Personal Social Services and societal perspectives, generating quality-adjusted life-years. Researchers collecting quantitative data were masked to participant allocation. SETTING: Two NHS mental health trusts and concomitant children's social care services. PARTICIPANTS: Parents who met the following criteria: (1) the primary caregiver of the index child, (2) aged 18-65 years, (3) have severe personality difficulties, (4) proficient in English and (5) capable of providing informed consent. Index children who met the following criteria: (1) aged 3-11 years, (2) living with index parent and (3) have significant emotional/behavioural difficulties. Exclusion criteria were (1) having coexisting psychosis, (2) participating in another parenting intervention, (3) receiving inpatient care, (4) having insufficient language/cognitive abilities, (5) having child developmental disorder, (6) care proceedings and (7) index child not residing with index parent. INTERVENTION: The Helping Families Programme-Modified - a 16-session intervention using structured, goal-orientated strategies and collaborative therapeutic methods to improve parenting, and child and parent functioning. Usual care - standard care augmented by a single psychoeducational session. MAIN OUTCOME MEASURES: Trial feasibility - rates of recruitment, eligibility, allocation, retention, data completion and experience. Intervention acceptability - rates of acceptance, completion, alliance (Working Alliance Inventory-Short Revised) and experience. Outcomes - child (assessed via Concerns About My Child, Eyberg Child Behaviour Inventory, Child Behaviour Checklist-Internalising Scale), parenting (assessed via the Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale), parent (assessed via the Symptom Checklist-27), and health economics (assessed via the Client Service Receipt Inventory, EuroQol-5 Dimensions). RESULTS: The findings broadly supported trial feasibility using non-diagnostic screening criteria. Parents were mainly referred from one site (75.0%). Site and participant factors delayed recruitment. An estimate of eligible parents was not obtained. Of the 86 parents referred, 60 (69.7%) completed screening and 48 of these (80.0%) were recruited. Participants experienced significant disadvantage and multiple morbidity. The Helping Families Programme-Modified uptake (87.5%) was higher than usual-care uptake (62.5%). Trial retention (66.7%, 95% confidence interval 51.6% to 79.6%) exceeded the a priori rate. Process findings highlighted the impact of random allocation and the negative effects on retention. The Helping Families Programme-Modified was acceptable, with duration of delivery longer than planned, whereas the usual-care condition was less acceptable. At initial follow-up, effects on child and parenting outcomes were detected across both arms, with a potential outcome advantage for the Helping Families Programme-Modified (effect size range 0.0-1.3). For parental quality-adjusted life-years, the Helping Families Programme-Modified dominated usual care, and child quality-adjusted life-years resulted in higher costs and more quality-adjusted life-years. At second follow-up, the Helping Families Programme-Modified was associated with higher costs and more quality-adjusted life-years than usual care. For child quality-adjusted life-years, when controlled for baseline EuroQol-5 Dimensions, three-level version, usual care dominated the Helping Families Programme-Modified. No serious adverse events were reported. CONCLUSION: The Helping Families Programme-Modified is an acceptable specialised parenting intervention. Trial methods using non-diagnostic criteria were largely supported. For future work, a definitive efficacy trial should consider site selection, recruitment methods, intervention efficiency and revised comparator condition. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14573230. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 14. See the NIHR Journals Library website for further project information.

Parents affected by personality difficulties experience strong, overwhelming emotions and struggle in their personal and social relationships. These difficulties can interfere with their ability to provide stable, safe and warm parenting, which increases the risk of their children developing mental health problems. This research developed the Helping Families Programme-Modified, a new parenting intervention designed to help parents with severe personality difficulties who have children with mental health problems. Parents received 16 home-based appointments to learn new parenting skills and improve their children's difficulties. The research assessed how the Helping Families Programme-Modified worked in practice and the viability of evaluation methods. A short questionnaire assessing personality difficulties, rather than a lengthy diagnostic interview, was more effective and acceptable for identifying parents who may benefit from the Helping Families Programme-Modified. Parents taking part had high levels of personal, family and social problems. This slowed the rate at which parents agreed to take part in the evaluation and lengthened the intervention period. The research tested parent agreement to being randomly allocated to receive either the Helping Families Programme-Modified or usual care plus a specially designed parenting appointment. Although this random allocation was feasible, parents were disappointed when they did not receive the Helping Families Programme-Modified. They often felt overwhelmed by family difficulties and lacked other suitable services. These parents were less likely to take up the additional parenting appointment available or to provide subsequent research information, which affected the certainty of the research findings. Parents receiving the Helping Families Programme-Modified or usual care reported improvements, with a potentially greater impact on parents and children, and better acceptability, for the new intervention. Parents generally supported the tailored, home-based approach of the Helping Families Programme-Modified, and they valued its content, therapist skills and persistence. It was uncertain whether the new intervention increased or reduced service costs. These results will be used to plan the most suitable methods for a large-scale evaluation of the Helping Families Programme-Modified.

Randomised feasibility trial of the helping families programme-modified: an intensive parenting intervention for parents affected by severe personality difficulties.

BACKGROUND: Specialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties. OBJECTIVE: Conduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention. DESIGN: Pragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates. SETTINGS: Two National Health Service health trusts and local authority children's social care. PARTICIPANTS: Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties. INTERVENTION: HFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session. OUTCOMES: Primary feasibility outcome: participant retention rate. SECONDARY OUTCOMES: (i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory). SECONDARY OUTCOMES: child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation. RESULTS: Findings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95% CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3). CONCLUSION: HFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported. TRIAL REGISTRATION NUMBER: ISRCTN14573230.

The ESCAPS study: a feasibility randomized controlled trial of early electrical stimulation to the wrist extensors and flexors to prevent post-stroke complications of pain and contractures in the paretic arm.

OBJECTIVE: To establish feasibility of initiating electrical stimulation treatment of wrist extensors and flexors in patients early after stroke to prevent muscle contractures and pain. DESIGN: Feasibility randomized controlled trial with economic evaluation. SETTING: A specialist stroke unit in Nottinghamshire. SUBJECTS: A total of 40 patients recruited within 72 hours post-stroke with arm hemiparesis. INTERVENTIONS: Participants were randomized to receive usual care or usual care and electrical stimulation to wrist flexors and extensors for 30 minutes, twice a day, five days a week for three months. Initial treatment was delivered by an occupational therapist or physiotherapist who trained participants to self-manage subsequent treatments. MEASURES: Measures of feasibility included recruitment and attrition rates, completion of treatment, and successful data collection. Outcome data on wrist range of motion, pain, arm function, independence, quality of life, and resource use were measured at 3-, 6-, and 12-months post-randomization. RESULTS: A total of 40 participants (of 215 potentially eligible) were recruited in 15 months (20 men; mean age: 72 (SD: 13.0)). Half the participants lacked mental capacity and were recruited by consultee consent. Attrition at three-month follow-up was 12.5% (death (n = 2), end-of-life care (n = 2), and unable to contact (n = 1)). Compliance varied (mean: 65 (SD: 53)) and ranged from 10 to 166 treatments per patient (target dosage was 120). Data for a valid economic analysis can be adequately collected. CONCLUSION: Early initiation of electrical stimulation was acceptable and feasible. Data collection methods used were feasible and acceptable to participants. A large definitive study is needed to determine if electrical stimulation is efficacious and cost effective.

Sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children: study protocol for a pragmatic randomised controlled trial.

BACKGROUND: Autism spectrum disorder (ASD) is a common lifelong condition affecting 1 in 100 people. ASD affects how a person relates to others and the world around them. Difficulty responding to sensory information (noise, touch, movement, taste, sight) is common, and might include feeling overwhelmed or distressed by loud or constant low-level noise (e.g. in the classroom). Affected children may also show little or no response to these sensory cues. These 'sensory processing difficulties' are associated with behaviour and socialisation problems, and affect education, relationships, and participation in daily life. Sensory integration therapy (SIT) is a face-to-face therapy or treatment provided by trained occupational therapists who use play-based sensory-motor activities and the just-right challenge to influence the way the child responds to sensation, reducing distress, and improving motor skills, adaptive responses, concentration, and interaction with others. With limited research into SIT, this protocol describes in detail how the intervention will be defined and evaluated. METHODS: This is a two-arm pragmatic individually 1:1 randomised controlled trial with an internal pilot of SIT versus usual care for primary school aged children (aged 4 to 11 years) with ASD and sensory processing difficulties; 216 children will be recruited from multiple sources. Therapy will be delivered in clinics meeting full fidelity criteria for manualised SIT over 26 weeks (face-to-face sessions: two per week for 10 weeks, two per month for 2 months; telephone call: one per month for 2 months). Follow-up assessments will be completed at 6 and 12 months post-randomisation. Prior to recruitment, therapists will be invited to participate in focus groups/interviews to explore what is delivered as usual care in trial regions; carers will be invited to complete an online survey to map out their experience of services. Following recruitment, carers will be given diaries to record their contact with services. Following intervention, carer and therapist interviews will be completed. DISCUSSION: Results of this trial will provide high-quality evidence on the clinical and cost effectiveness of SIT aimed at improving behavioural, functional, social, educational, and well-being outcomes for children and well-being outcomes for carers and families. TRIAL REGISTRATION: ISRCTN14716440 . Registered on 8 November 2016.

The impact of a computerised test of attention and activity (QbTest) on diagnostic decision-making in children and young people with suspected attention deficit hyperactivity disorder: single-blind randomised controlled trial.

BACKGROUND: Diagnosis of attention deficit hyperactivity disorder (ADHD) relies on subjective methods which can lead to diagnostic uncertainty and delay. This trial evaluated the impact of providing a computerised test of attention and activity (QbTest) report on the speed and accuracy of diagnostic decision-making in children with suspected ADHD. METHODS: Randomised, parallel, single-blind controlled trial in mental health and community paediatric clinics in England. Participants were 6-17 years-old and referred for ADHD diagnostic assessment; all underwent assessment-as-usual, plus QbTest. Participants and their clinician were randomised to either receive the QbTest report immediately (QbOpen group) or the report was withheld (QbBlind group). The primary outcome was number of consultations until a diagnostic decision confirming/excluding ADHD within 6-months from baseline. Health economic cost-effectiveness and cost utility analysis was conducted. Assessing QbTest Utility in ADHD: A Randomised Controlled Trial was registered at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02209116). RESULTS: One hundred and thirty-two participants were randomised to QbOpen group (123 analysed) and 135 to QbBlind group (127 analysed). Clinicians with access to the QbTest report (QbOpen) were more likely to reach a diagnostic decision about ADHD (hazard ratio 1.44, 95% CI 1.04-2.01). At 6-months, 76% of those with a QbTest report had received a diagnostic decision, compared with 50% without. QbTest reduced appointment length by 15% (time ratio 0.85, 95% CI 0.77-0.93), increased clinicians' confidence in their diagnostic decisions (odds ratio 1.77, 95% CI 1.09-2.89) and doubled the likelihood of excluding ADHD. There was no difference in diagnostic accuracy. Health economic analysis showed a position of strict dominance; however, cost savings were small suggesting that the impact of providing the QbTest report within this trial can best be viewed as 'cost neutral'. CONCLUSIONS: QbTest may increase the efficiency of ADHD assessment pathway allowing greater patient throughput with clinicians reaching diagnostic decisions faster without compromising diagnostic accuracy.