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临床试验/NCT03832270
NCT03832270Unknown不适用

SPARCLAR: A Feasibility Randomised Controlled Trial of a Parenting Support Programme Focussed on Families Affected by ADHD

University of Glasgow1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Number of parents willing to be randomised to Parents InC or Incredible Years.

研究概览

简要总结

Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic and pervasive disorder characterised by problems in attention, impulse control and activity regulation that substantially burdens patients, families, and society. The efficacy of behavioural training for parents of children with ADHD symptoms is well established, however it is less clear which type of parenting intervention should be offered, and which aspects of parenting behaviour to focus on. It is not established whether an intervention designed specifically for families of children with a diagnosis will be more effective and cost effective than less specifically-targeted interventions. The purpose of this study is to determine the feasibility and likely size of a substantive randomised controlled trial comparing an AHDH specific parenting intervention to a diagnostically less-specific parenting intervention.

详细描述

Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic and pervasive disorder characterised by problems in attention, impulse control and activity regulation that substantially burdens patients, families, and society. ADHD is often associated with challenging behaviours that can induce negativity, even in parents who would otherwise cope well.The efficacy of behavioural training for parents of children with ADHD symptoms is well established, however it is less clear which type of parenting intervention should be offered, and which aspects of parenting behaviour to focus on. It is not established whether an intervention designed specifically for families of children with a diagnosis will be more effective and cost effective than less specifically-targeted interventions.

Parents In Control (Parents InC) offers specific support around empowerment, information and behaviour management specific to ADHD, as well as understanding of the child's development context. Parents InC has been used for a number of years in Scotland and has been evaluated, with promising results, but with relatively small sample sizes, no long-term follow-up, no economic evaluation and, most crucially, no comparison to an alternative intervention or to a control group. The investigators now need to understand if it: i) is at least as effective as the current best-evidenced alternative, Incredible Years, in impacting children's behaviour outcomes; ii) is cost-effective; and iii) offers something helpful and unique compared to other parenting programmes in terms of parenting self-competence and quality of life.

The purpose of this study is to determine the feasibility and likely size of a substantive randomised controlled trial comparing an ADHD specific parenting intervention to a diagnostically less-specific parenting intervention (Incredible Years). Specific objectives are to test (1) whether parents of children recently diagnosed with ADHD are willing to be randomised to Parents InC or IY; (2) whether sufficient numbers of families can be (a) recruited and (b) retained such that a full-scale RCT is likely to be feasible; (3) whether research procedures and efficacy measures are feasible and acceptable to participating families (including health economic measures and consent to link to routine datasets); (4) whether families participating in Parents InC achieve similar scores on the parenting sense of competence scale at 12 months post randomisation as those in the comparison arm (Incredible Years); (5) Whether the two intervention arms significantly differ on any other measures; and (6) the mean cost per participant of Parents InC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants and assessors will be blind to treatment allocation.

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Parents of children aged 5-12 with a formal diagnosis of ADHD, following a standardised assessment from a paediatrician or a psychiatrist, referred to the Fife integrated ADHD pathway during the one year recruitment period will be eligible for inclusion.

排除标准

  • •Families attending other parenting groups
  • •Parents who have low proficiency in English (as this will compromise their ability to complete research measures or participate in a group intervention).
  • •Participants already taking part in research on a parenting intervention will also be ineligible to participate.

研究组 & 干预措施

Parents InC

Experimental

Group parenting support intervention based around four pillars: 1) empowerment/ownership; 2) education on ADHD and its effect on family identity/ values; 3) positive parenting in the context of ADHD; 4) making sense of ADHD in a developmental context. It is delivered over 5 weekly 2-hour sessions, a 6 week break, and a follow-up session.

干预措施: Parents InC (Behavioral)

Incredible Years

Active Comparator

A group parenting support intervention aimed at strengthening parent-child interactions and attachment, reducing harsh discipline and fostering parents' ability to promote children's social, emotional, and academic development. The IY programme is delivered over 14 weekly 2-hour sessions. IY facilitators are videotaped during sessions to maintain intervention fidelity. IY also includes 1-4 pre-intervention preparation sessions which may involve home visits and telephone support and reminders.

干预措施: Incredible Years (Behavioral)

结局指标

主要结局

Number of parents willing to be randomised to Parents InC or Incredible Years.

时间窗: Continuous over 1 year study period

Measured by number of parents agreed to randomisation throughout the study period.

Number of parents recruited and retained.

时间窗: Continuous over 1 year study period

Measured by number of parents recruited and retained throughout the study period.

Research procedures feasibility and acceptability

时间窗: Continuous over 1 year study period

Face to face interviews will be conducted with participating families to assess the feasibility and acceptability of research procedures.

次要结局

  • Participant service use(12-month post-randomisation)
  • Eyberg Child Behaviour Inventory.(Baseline, 12-month post-randomisation)
  • General Health Questionnaire.(Baseline, 12-month post-randomisation)
  • ADHD Symptom Rating Scale-Version 1.(Baseline, 12-month post-randomisation)
  • Paediatric Quality of Life Inventory (PedsQL)(Baseline, 12-month post-randomisation)
  • Goal Based Outcomes.(Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation)
  • Primary efficacy outcome: Parental Sense of Competence Scale.(Baseline, 12-months post-randomisation)
  • EQ-5D-5L(Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation)
  • Parenting Daily Hassles Scale.(Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation)
  • Strengths and Difficulties Questionnaire (SDQ)(Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucy Thompson

International Research Coordinator & Research Fellow

University of Glasgow

研究点 (1)

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