The effectiveness of behavioral parent training techniques for children with attention-deficit/hyperactivity disorder
|- candidate number||28064|
|- NTR Number||NTR6775|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-okt-2017|
|- Secondary IDs||2016/197 METc van het UMCG|
|- Public Title||The effectiveness of behavioral parent training techniques for children with attention-deficit/hyperactivity disorder
|- Scientific Title||A randomized controlled microtrial into the effectiveness of behavioral parent training techniques for children with attention-deficit/hyperactivity disorder
|- hypothesis||The aims of the study are: |
To investigate the short-term effectiveness of antecedent and consequent behavioral parent training techniques for parents of children (four to twelve years old) with attention-deficit/hyperactivity disorder (ADHD) on primary outcomes (target problem behaviors) and secondary outcomes (behavioral and emotional problems).
To identify child and parental factors that may moderate the effectiveness of these antecedent and consequent techniques.
To exploratory compare the consumption of psychosocial care and medication between three study arms (i.e. antecedent techniques training, consequent techniques training, waiting list) three months after completion of the parent training techniques.
|- Healt Condition(s) or Problem(s) studied||ADHD, Behavioral problems, Children, Parenting training|
|- Inclusion criteria||1. The child has a DSM-5 or DSM-IV-TR based diagnosis of ADHD, (Diagnostic Interview Schedule for Children for DSM-IV, parent version, module Disruptive Behavior Disorders [DISC-IV; Shaffer, Fisher, Lucas, Dulcan, & Schwab-Stone, 2000]).|
2. The child is four to twelve years old.
3. Both parents/caregivers, if available, are willing and able to participate in the training.
4. The child has an (estimated) IQ higher than 70.
5. The child is not taking psychotropic medication or has been off medication for at least one month.
5. Parents/caregivers have given their informed consent for participation.
|- Exclusion criteria||1. There are problems with the child and/or the family that require immediate intensive intervention (e.g., crisis in the family).|
2. The parent(s) received behavioral parent training (individual or group) aimed at ADHD or behavioral problems of the child in the past year.
3. The child does not live in one household during weekdays.
4. It is not a suitable period for the family and/or the child to participate in the study (e.g. moving, divorce, holidays or vacation).
5. The child has a DSM-5 or DSM-IV-TR based diagnosis of conduct disorder.
6. The child has a DSM-5 or a DSM-IV-TR based diagnosis of an autism spectrum disorder.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2017|
|- planned closingdate||1-jan-2019|
|- Target number of participants||90|
|- Interventions||This study has three arms: an antecedent techniques training, a consequent techniques training, and a waiting list. |
- The antecedent techniques training consists of two two-hour sessions with parents, spread over two weeks, in which the parents will be given psycho-education and will be trained in antecedent techniques that are common in behavioral parent training (e.g., providing structure, giving clear instructions).
- The consequent techniques training consists of two two-hour sessions with parents, spread over two weeks, in which the parents will be given psycho-education and will be trained in consequent techniques that are common in behavioral parent training (e.g., reinforcement techniques, planned ignoring).
- The waiting list control condition consists of five weeks without training. After post-training assessment two, parents will get treatment as usual.
|- Primary outcome||The primary outcome of this study will consist of daily assessments of problem behaviors. Parents will be asked to select four target behaviors in specific situations. During baseline, post-training assessment 1 and post-training assessment 2, during five consecutive school days (at least four assessments), daily phone calls will be made by the investigational team, in which parents will be asked if the target behaviors had been present in the specific situations in the past 24 hours and, if yes, to provide severity ratings of these behaviors on a 5-point scale.|
|- Secondary outcome||- Inattentive and hyperactive/impulsive behaviors (Strengths and Weaknesses of ADHD Symptoms and Normal behavior rating scales [SWAN; Swanson et al., 2012]).|
- Oppositional defiant behavior of the child (ODD scale of the Disruptive Behavior Rating Disorder Scale-Parent Version [DBD; Pelham, Gnagy, Greenslade, & Milich, 1992; Oosterlaan, Scheres, Antrop, Roeyers, & Sergeant, 2008]).
- Behavioral and emotional functioning of the child (Strengths and Difficulties Questionnaire [SDQ; Goodman, 1997]).
- Impairment of the child at school (Impairment Rating Scale – Parent version [IRS-P-NL; Fabiano et al., 2006])
|- Timepoints||There will be four measurement points. Parents will fill out questionnaires at all measurement points, teachers will fill out questionnaires at baseline and at post-training assessment 2. |
1) Baseline assessment before randomization.
2) Post-training assessment 1 after the training/waitlist.
3) Post-training assessment 2 two weeks after the end of the training/waitlist.
4) Three month follow-up assessment. This measurement takes place three months after the start of training/waitlist completion.
|- Trial web site||www.paint-studies.nl/projects/paint-p|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Rianne Hornstra|
|- CONTACT for SCIENTIFIC QUERIES|| Rianne Hornstra|
|- Sponsor/Initiator ||Accare - Child Study Center|
(Source(s) of Monetary or Material Support)
|ZonMw, Accare - Child Study Center, Katholieke Universiteit Leuven|
|- Brief summary||Behavioral parent training is a one of the most studied psychosocial interventions and has considerable empirical support. However, on average, behavioral parent training programs for children with ADHD only have moderate effect-sizes, that even become small at long term follow-up (Lee et al., 2012). Thus, studies aimed at increasing the effectiveness of behavioral parent training programs are warranted. Behavioral parent training programs are usually investigated as a ‘whole package’ (e.g., Nowak & Heinrichs, 2008; Thomas & Zimmer-Gembeck, 2012; Van den Hoofdakker et al., 2007), while studies that aim to study the effectiveness of isolated elements are relatively scarce. There are many variants of behavioral parent training programs (Chronis, Chacko, Fabiano, Wymbs & Pelham, 2004), with diversity in content, duration, format, and setting. In terms of content, behavioral parent training programs consist of a lot of different techniques (Dishion, Stormshak & Kavanagh, 2011). Despite this diversity, all parent training programs share similar underlying behavioral principles, i.e., changing behaviors by manipulating their antecedents (e.g., structure, instructions) and by managing their consequences (e.g. reward, ignoring, punishment).|
In the current study, we compare the effects of antecedent techniques (n=30), consequent techniques (n=30) and a waiting list condition (n=30) in a randomized microtrial on selected target behaviors for children 4-11 years old with ADHD and behavior problems. We aim to determine the effects of the techniques on our primary outcome (daily assessments of four selected target behaviors) and secondary outcomes (behavioral and emotional functioning, including ADHD- and ODD symptoms) and to identify which child and parental factors (e.g. cognitive functioning, attachment) may influence the effectiveness of the techniques.
The active study arms consist of a baseline measurement followed by two protocolled training sessions with homework to practice learned skills. Immediately after the training, 2 weeks and 12 weeks after the training, post-training assessments will take place The waiting list condition includes a baseline measurement followed by two weeks of no intervention. Assessments will take place 2 weeks, 4 weeks and 14 weeks after the baseline measurement .
The study will include parents of non-medicated children (4 through 11 years old) with a DSM-5 or DSM-IV-TR based diagnosis of ADHD, (Diagnostic Interview Schedule for Children for DSM-IV, parent version, module Disruptive Behavior Disorders [DISC-IV; Shaffer, Fisher, Lucas, Dulcan, & Schwab-Stone, 2000]) and an IQ ≥ 70.
|- Main changes (audit trail)|
|- RECORD||22-okt-2017 - 11-nov-2017|
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