A Randomized Controlled Multicenter Trial on the Effectiveness and Acceptability of a Brief Behavioral Training for Parents of Children With Behavioral Difficulties in Primary Care Settings
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Severity of four daily rated target behaviors in specific home situations
研究概览
简要总结
The goal of this two-armed randomized controlled trial is to investigate the effectiveness of a new, individually tailored, brief behavioral training for parents of children with behavioral difficulties in general practitioners' practices.
The main questions the study aims to examine are:
- The short-term effectiveness of a brief and individually-tailored, behavioral parent training program in primary care settings on the severity of four daily rated target behaviors in specific home situations, compared to care as usual (CAU).
- The short-term effectiveness of the brief parent training compared to CAU on secondary outcome measures: severity of the same four daily rated target behaviors in other home situations, severity of child disruptive behaviors, number of child disruptive behaviors perceived as troublesome by the parents, overall impairment of child behavioral difficulties, impact of child behavioral difficulties on the relationship with parents, parenting behaviors, parenting stress and parenting self-efficacy.
- The longer-term outcomes (three month follow-up) of the brief parent training program on primary and secondary outcomes.
- The satisfaction and acceptability of the brief parent training program in primary care settings as perceived by parents and child mental health workers.
Parents will be randomly assigned (simple and parallel randomization) to (a) the intervention condition in which parents receive three sessions of brief parent training and may receive CAU, or (b) the control condition in which parents may receive CAU. The brief parent training provides parents with individually tailored stimulus control and contingency management techniques to treat children's behavioral difficulties in two (bi)weekly training sessions of two hours and a third session of one hour in which the training will be evaluated and maintenance training will be provided. CAU may include any support or treatment as regularly provided by general practices, mental health care centers, schools and/or other organizations, except from pharmacological treatment for children's behavioral difficulties and/or behavioral parent training/support. CAU may also imply that there is no support or treatment. After the first posttreatment assessment (T1) parents in the control condition will be offered the brief parent training as well.
详细描述
STUDY DESIGN
We will conduct a two-armed randomized controlled trial. Children and their parents will be randomly assigned (simple and parallel randomization) to (a) the intervention condition in which parents receive the brief parent training and may receive care as usual, or (b) the control condition in which parents may receive care as usual only.
The trial will take place in several general practitioners' practices throughout the Netherlands. The brief parent training will be provided by child mental health workers (in Dutch: praktijkondersteuners GGZ kind en jeugd).
TIME FRAME
December 2023: start recruitment, screening and inclusion of parents and children, start running interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The child is aged 2 to (until and including) 11 years old;
- •Parents have to identify at least four behavioral difficulties of the child at home that they want to target in the training (using the list of 29 target behavioral difficulties (Van den Hoofdakker 2007; Hornstra et al., 2021)).
排除标准
- •Current psychotropic medication use of the child (at least not in the month before the training);
- •The child has a diagnosis of autism spectrum disorder (as reported by parents, we will not perform any measures to assess autism spectrum disorder);
- •The child has an IQ-score of less than 70 (as reported by parents, we will not perform any measures to determine the IQ-score);
- •Parents received support or training aimed at remediating behavioral difficulties of the concerned child in the year before the study;
- •Not a suitable period for the parents and/or the child to participate in the study (e.g., moving, divorce);
- •The child is not living in the same household during at least four weekdays, to ensure that that parent(s) are able to practice the techniques with their child during the week.
结局指标
主要结局
Severity of four daily rated target behaviors in specific home situations
时间窗: Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).
The primary outcome will be the severity of four parent-rated target behaviors. Parents select four daily occurring behavioral difficulties of the child at home and specific situations in which these behaviors occur. Target behaviors will be selected from an adapted version of a list of 29 possible target behaviors (Hornstra et al., 2021; Van den Hoofdakker et al., 2007), of which parents indicate daily occurrence (yes/no) and (if yes) the severity on a 5-point Likert scale from 1 (not severe) to 5 (extremely severe). Specific situations will be selected from the Home Situation Questionnaire (Breen \& Altepeter, 1991). The severity of the four target behaviors within specific situations will be measured with brief daily telephone calls on at least four consecutive school days by the researchers. Parents will be asked whether the four selected target behaviors occurred in the past 24 hours in the selected situation (yes/no) and (if yes) rate the severity on a 5-point Likert scale.
次要结局
- Parent-reported severity of child disruptive behaviors(Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).)
- Parent-reported number of child disruptive behaviors that parents consider as troublesome(Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).)
- Parenting behaviors(Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).)
- Parenting stress(Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).)
- Parenting self-efficacy and sense of competence(Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).)
- Severity of the same four daily rated target behaviors in other home situations than the specified situation which is used as primary outcome (see primary outcome measure for details on administration)(Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).)
- Parent-reported overall impairment of child behavioral difficulties(Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).)
- Parent-reported impact of child behavioral difficulties on the relationship with parents(Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).)