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

التفاصيل البيبلوغرافية
العنوان:	Clinical and cost-effectiveness of an adapted intervention for preschoolers with moderate to severe intellectual disabilities displaying behaviours that challenge: the EPICC-ID RCT.
المؤلفون:	Ondruskova T; Division of Psychiatry, University College London, London, UK., Royston R; Division of Psychiatry, University College London, London, UK., Absoud M; Evelina Hospital, Guys and St Thomas's NHS Foundation Trust, London, UK., Ambler G; Department of Statistical Science, University College London, London, UK., Qu C; Department of Statistical Science, University College London, London, UK., Barnes J; Department of Psychological Sciences, Birkbeck University, University of London, London, UK., Hunter R; Research Department of Primary Care and Population Health, University College London, Royal Free Medical School, London, UK., Panca M; Research Department of Primary Care and Population Health, University College London, Royal Free Medical School, London, UK., Kyriakopoulos M; South London and Maudsley NHS Foundation Trust, Michael Rutter Centre, Maudsley Hospital, London, UK.; National and Kapodistrian University of Athens, Vyronas-Kessariani Community Mental Health Centre, Athens, Greece.; Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Oulton K; Great Ormond Street Hospital, London, UK., Paliokosta E; The Tavistock and Portman NHS Foundation Trust, Kentish Town Health Centre, London, UK., Sharma AN; Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust and Newcastle University, Walkergate Park Centre for Neurorehabilitation and Neuropsychiatry, Newcastle upon Tyne, UK., Slonims V; Evelina Hospital, Guys and St Thomas's NHS Foundation Trust, London, UK., Summerson U; Contact, London, UK., Sutcliffe A; Institute of Child Health, University College London, London, UK., Thomas M; Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK., Dhandapani B; Lewisham and Greenwich NHS Trust, Queen Elizabeth Hospital, London, UK., Leonard H; Great North Children's Hospital, Victoria Wing, Royal Victoria Infirmary, Newcastle upon Tyne, UK., Hassiotis A; Division of Psychiatry, University College London, London, UK.
المصدر:	Health technology assessment (Winchester, England) [Health Technol Assess] 2024 Jan; Vol. 28 (6), pp. 1-94.
نوع المنشور:	Journal Article; Multicenter Study; Pragmatic Clinical Trial; Randomized Controlled Trial
اللغة:	English
بيانات الدورية:	Publisher: NIHR Journals Library Country of Publication: England NLM ID: 9706284 Publication Model: Print Cited Medium: Internet ISSN: 2046-4924 (Electronic) Linking ISSN: 13665278 NLM ISO Abbreviation: Health Technol Assess Subsets: MEDLINE
أسماء مطبوعة:	Publication: <2013-> : Southampton, UK : NIHR Journals Library Original Publication: Winchester, UK : National Co-Ordinating Centre for HTA, c1997-
مواضيع طبية MeSH:	COVID-19* , Intellectual Disability*, Child, Preschool ; Humans ; Cost-Benefit Analysis ; London ; Quality of Life ; Single-Blind Method
مستخلص:	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.
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فهرسة مساهمة:	Keywords: BEHAVIOURS THAT CHALLENGE; CHALLENGING BEHAVIOUR; CHILDREN; COVID-19; DEVELOPMENTAL DISABILITIES; INTELLECTUAL DISABILITIES; INTERVENTION; MODERATE-SEVERE; PARENT–CHILD INTERACTIONS; PATIENT AND PUBLIC INVOLVEMENT; PRESCHOOL; PROBLEM BEHAVIOUR; RANDOMISED CONTROLLED TRIALS Local Abstract: [plain-language-summary] 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 30–59 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.
سلسلة جزيئية:	ClinicalTrials.gov NCT03086876
تواريخ الأحداث:	Date Created: 20240208 Date Completed: 20240212 Latest Revision: 20240425
رمز التحديث:	20240425
مُعرف محوري في PubMed:	PMC11017145
DOI:	10.3310/JKTY6144
PMID:	38329108
قاعدة البيانات:	MEDLINE

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تدمد:	2046-4924
DOI:	10.3310/JKTY6144