Brief Parent Training for Children With Behavioral Difficulties in Primary Care Settings

NCT06160193 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-02

No results posted yet for this study

Summary

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:

1. 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).
2. 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.
3. The longer-term outcomes (three month follow-up) of the brief parent training program on primary and secondary outcomes.
4. 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.

Conditions

  • Behavioral Difficulties

Interventions

BEHAVIORAL

Brief behavioral parent training with optional care as usual

A brief behavioral parent training program that combines individually-tailored stimulus control and contingency management techniques to treat children's behavioral difficulties in two (bi)weekly training sessions of 120 minutes, and a third session of 60 minutes, in which the training will be evaluated and maintenance training will be provided.

OTHER

Care as usual

Care as usual may include all mental health care that is usually provided within or outside (e.g., at a child mental healthcare institution or at school) the general practitioners practice, except from pharmacological treatment for children's behavioral difficulties and/or behavioral parent training/support, up until the first posttreatment assessment (T1). Care as usual can also imply that there is no support or treatment.

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
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06160193 on ClinicalTrials.gov