A Randomized Controlled Trial on Brief Behavioral Parent Training

Summary

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.

Conditions

• Disruptive Behavior
• Behavior Problems
• Behavioral Problems
• Problem Behaviors
• Behavioral Symptoms
• Behavioral Difficulties

Interventions

BEHAVIORAL

Brief behavioral parent training with optional booster sessions

A 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.

BEHAVIORAL

Care as usual

The 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.

Sponsors & Collaborators

• Accare

  lead OTHER

Principal Investigators

• Barbara J. Van den Hoofdakker, Prof. dr. · Accare Child Study Center; University Medical Center Groningen; University of Groningen

• Saskia Van der Oord, Prof. dr. · KU Leuven

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-17

Primary Completion

2024-12-31

Completion

2026-12-31

Countries

• Netherlands

Study Locations