A Non-randomized Pilot Study on Brief Behavioral Parent Training for Behavioral Problems of Children With ADHD Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in daily ratings of target behaviors by ecological momentary assessment
研究概览
简要总结
This pilot study investigates a new, easily applicable, individually tailored first-line behavioral training for parents of children (4-12 years) with (symptoms of) ADHD, that will be provided in an early stage, before other treatments have been applied. In this pilot study the feasibility of the newly developed intervention will be evaluated by exploring program acceptability, including client satisfaction, recruitment, retention, treatment fidelity and therapist satisfaction. Also acceptability of potential outcome measures will be explored, including preliminary tests of efficacy.
详细描述
The study will be a non-randomized pilot study. The newly developed brief behavioral parent training has not been studied yet. Therefore, the current project aims at evaluating its feasibility. Furthermore, this project aims to explore whether parents' and their children's functioning improves from pre to post intervention. This will be assessed by investigating changes over time in the treatment group, and, if possible, by comparing these with changes in a control group that was included in a previous microtrial with an almost identical design and intervention.
OBJECTIVES
The primary objective of this study is evaluating the feasibility of the newly developed behavioral parent training This will be done by exploring its acceptability, including client satisfaction, recruitment, retention, treatment fidelity and therapist satisfaction. Furthermore, the acceptability of both primary and secondary outcome measures will be evaluated on a number of variables, such as frequency and duration of the assessment according to participants and response and completion rates. Preliminary tests of efficacy will be conducted by investigating changes over time in the treatment group, and, if possible, comparing all outcome measures with control data from a previous study that has an almost identical design.
METHODS
Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A) The child is diagnosed with ADHD according to DSM-5 as measured by the Parent Interview for Child Symptoms [PICS] and the Teacher Telephone Interview [TTI] or; B) The child has at least four impairing symptoms of ADHD (at least four symptoms of ADHD as measured by the Parent Interview for Child Symptoms [PICS] and at least two symptoms measured by the Teacher Telephone Interview [TTI]; and significant impairment rated >3 on the Impairment Rating Scale [IRS]).
- •The child is between four up to and including eleven years old and is attending a Dutch primary school.
- •The child has an IQ higher than
- •If an IQ-score is not available, this will be estimated with two subtests of the Wechsler Intelligence Scale for Children-V (Dutch edition; WISC-V-NL) or the Wechsler Preschool and Primary Scale of Intelligence-III (Dutch edition; WPSSI-III-NL).
- •Parents/caregivers have given their informed consent for participation.
排除标准
- •Parents received behavioral parent training (individual or group) aimed at ADHD or behavioral problems of the child in the past year.
- •The child is currently taking psychotropic medication or has taken psychotropic medication in the past month.
- •The child has a DSM-5 or a DSM-IV-TR based diagnosis of an Autism Spectrum Disorder.
- •There are problems with the child and/or the family that require immediate intensive intervention (e.g., crisis in the family).
- •The child does not live in one household during weekdays.
研究组 & 干预措施
Brief behavioral parent training
A newly developed, easily applicable, individually tailored first-line behavioral training for parents of children (4-12 years) with behavioral problems and (symptoms of) ADHD, that will be provided in an early stage, before other treatments have been applied.
干预措施: Brief behavioral parent training (Behavioral)
结局指标
主要结局
Change in daily ratings of target behaviors by ecological momentary assessment
时间窗: T0 (baseline) 1 week before intervention; T1 (post-training 1) 1 week after intervention session 2; T2 (post-training 2) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session.
The primary outcome measure will be daily ratings of 4 selected target behaviors. The target behaviors will be selected from a list of 31 problem behaviors on which parents indicate whether these behaviors daily occur (yes/no). For the items scored as yes parents rate the severity of the behaviors on a 5-point Likertscale ranging from 1 not severe to 5 extremely severe. Parents will be asked to choose 4 target behaviors from this list (i.e. the behaviors that they prefer to work on in the training). They will also be asked to specify in which situations these behaviors typically occur. During a week (5 schooldays), a member of the research team will make daily phone calls with participating parents to evaluate whether the 4 selected target behaviors occurred in the past 24 hours (yes/no). Items scored as No will be rated 0, items scored as Yes will be rated on a 5-point Likertscale ranging from 1 not severe to 5 extremely severe (daily score min = 0, max = 20).
次要结局
- Change in children's symptoms of oppositional defiant disorder(T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session)
- Change in parenting sense of competence(T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session)
- Change in inattentive, hyperactive and impulsive behaviors of the child.(T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session)
- Change in disruptive problem behaviors of the child(T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session)
- Change in impairment of the child(T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session)