About this trial
RATIONALE: The access to and uptake of evidence-based behavioral parent training for children with behavioral difficulties (i.e., oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behavior) are currently limited because of a scarcity of certified therapists and long waiting lists. These problems are in part due to the long and sometimes perceived as rigid nature of most evidence-based programs and result in few families starting behavioral parent training and high dropout rates. Brief and individually tailored parenting interventions may reduce these problems and make behavioral parent training more accessible.
OBJECTIVES: This project aims to increase the effective use of parent training for children with behavioral difficulties by (1) examining short and longer-term effectiveness of a new, brief, individual, and individually-tailored parent training program with optional booster sessions to prevent relapse, compared to care as usual (CAU); (2) assessing the cost-effectiveness of the brief parent training program compared to CAU.
STUDY DESIGN: In this two-arm, multi-center randomized controlled trial (RCT), parents are randomly assigned (1:1 ratio) to either (a) three sessions of brief behavioral parent training with optional booster sessions, or (b) CAU, as regularly provided by the involved mental healthcare centers. The study outcomes are measured at baseline before randomization (T0), one week after the third session for parents in the brief behavioral parent training arm and eight weeks after T0 for parents in the CAU arm (first posttreatment measurement, T1), six months after T1 (second posttreatment measurement, T2) and twelve months after T1 (third posttreatment measurement, T3).
STUDY POPULATION: Parents of children who experience behavioral difficulties in the home setting and were referred to a child mental healthcare center.
INTERVENTION: Parents in the intervention arm receive a short, individualized, three-session training primarily aimed at reducing children's behavioral problems. It exists of two (bi)weekly individually tailored 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. After that, parents wishing to receive additional support can receive single booster sessions maximum once every four weeks and/or receive care as usual. Parents in the control arm receive care as usual for children's behavioral problems. The treatments in both arms are fully embedded in Dutch routine mental health care.
MAIN STUDY PARAMETERS: The primary outcome is the severity of four individual target behavioral difficulties that parents want to address in the training. Secondary outcomes are parent-reported behavioral difficulties, parent-reported child well-being, parent-reported parenting behaviors, masked audio records of mealtime routines to measure parent and child behavior, parent-reported parenting stress, parent-reported parenting self-efficacy, parent-reported parental attitude towards their child, consumption and cost of mental health care, and health state utility values. We furthermore measure evaluations of the program by parents and therapists and explore whether parental attachment, parental psychopathology, parental reward responsivity, parent-reported child reward responsivity and punishment sensitivity moderate the intervention effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The child is aged between 2 and 12 years;
Parents have to identify at least four behavioral difficulties of the child that occur in the home setting and that they want to target in the training, using an adapted version of a list of target behaviors (Van den Hoofdakker et al., 2007; Hornstra et al., 2021). This list contains 29 behaviors that can be targeted in the training, such as hyperactive, impulsive, inattentive, oppositional and defiant behavior. The items are derived from target problems that parents mentioned in previous behavioral parent training groups and concern child behaviors that are commonly targeted in behavioral parent training in clinical practice, confirming ecological validity (Van den Hoofdakker et al., 2007).
Disqualifiers
The child uses psychotropic medication (currently or in the month before the screening);
The child has at any time received a diagnosis of autism spectrum disorder (ASD) in clinical practice, as (parents of) children with ASD may have different needs and therefore may require different treatments than children with behavioral difficulties without ASD;
The child has a known IQ-score below 70, as (parents of) children with intellectual disabilities may have different needs and therefore may require different treatments than children with behavioral difficulties and typical intellectual abilities;
Parents received behavioral parent training aimed at reducing the behavioral difficulties of the concerned child in the year prior to the start of the study;
Trial design
Parallel
Treatments tested in this trial
Brief behavioral parent training with optional booster sessions
BehavioralA brief and individually-tailored behavioral parent training program that combines stimulus control and contingency management techniques to treat children's behavioral difficulties in three (bi)weekly sessions and optional booster sessions.
Care as usual
BehavioralThe care that is usually provided by the clinical institutions to treat children's behavioral difficulties. There are no restrictions regarding type or duration of CAU (only the brief parent training will not be allowed) which may for example include psychoeducation, (long) parent training, child treatment (e.g., pharmacotherapy, cognitive behavioral therapy) or family therapy.
Treatment groups
Trial outcomes
Primary outcomes
Change in individually determined daily ratings of behavioral difficulties
The primary outcome is the mean severity of parents' daily ratings of four selected target behaviors in specific home situations. On the adapted version of the list of target behaviors (Van den Hoofdakker et al., 2007; Hornstra et al., 2021), parents indicate whether the 29 behaviors occur daily (yes/no). For behaviors scored as yes, parents rate the severity on a 5-point Likert scale ranging from 1 (not severe) to 5 (extremely severe). With a researcher, parents choose four daily occurring target behaviors from this list that they prefer to work on in the training. Parents also indicate in which situation these behaviors occur. For each measurement occasion, during five consecutive weekdays, short daily phone calls with parents are made to evaluate whether the four selected target behaviors occurred in the past 24 hours in the selected situation (yes/no). For each timepoint, the average score of all four behaviors on all weekdays is used as outcome measure.
Secondary outcomes
Change in parent-reported behavioral difficulties
Change in parent-reported child disruptive behaviors is assessed with the Intensity scale of the Eyberg Child Behavior Inventory (ECBI-I) (Eyberg \& Ross, 1978). The Intensity scale consists of 36-items for parents of children aged 2 to 16 and measures the frequency of specific problem behavior on a 7-point Likert scale from 1 (never) to 7 (always). The convergent and divergent validity and the reliability of the ECBI-I are well established (Abrahamse et al., 2015).
Change in child well-being
Change in child well-being is assessed with the Health-Related Quality of Life Questionnaire (KINDL-R) (Ravens-Sieberer \& Bullinger, 1998). Parents rate their children's quality of life on 20 items regarding emotional well-being, self-esteem, family functioning, social contacts, and school, of which the total score will be used. Parents rate the items on a Likert scale ranging from 1 (never) to 5 (all the time). The KINDL-R has revealed sufficient internal consistency (α = .82) (Bullinger et al., 2008).
Change in parenting behaviors
Change in parenting behaviors is assessed with the Alabama Parenting Questionnaire (APQ; Shelton et al., 1996). The APQ is a 42-item parent-report measure assessing five categories of parenting practices (involvement, positive parenting, poor monitoring/supervision, inconsistent discipline, and corporal punishment), of which the total score will be used. Parents rate their parenting on a 5-point scale ranging from 1 (never) to 5 (always), with higher scores representing higher levels of the particular parenting category. The reliability and validity of the APQ are well established (Shelton et al., 1996).
Change in observed parent and child behaviors (audiotapes - masked measure)
Change in observed parent and child behaviors is assessed with a masked measure. Parents are asked to audio record their mealtime routines for at least 15 minutes on two different weekdays. Mealtimes are notoriously busy times in family lives and thus well suited as a setting for an ecologically valid measure. The recordings of mealtime routines are a masked measure (i.e., assessors are not aware of the intervention condition), based on the method that was used by Herbert et al. (2013). Using the recordings, the following behaviors will be scored with a global coding system: parental behavior (both supportive and non-supportive parenting), child misbehavior, and emotional talk. A subsample of recordings will be double coded until sufficient interrater reliability is established.