Actively Recruiting

Phase Not Applicable
Age: 2Years - 11Years
All Genders
NCT05591820

A Randomized Controlled Trial on Brief Behavioral Parent Training

Led by Accare · Updated on 2024-07-31

93

Participants Needed

1

Research Sites

215 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

A Randomized Controlled Trial on Brief Behavioral Parent Training

Who Can Participate

Age: 2Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The child is aged between 2 and 12 years
  • Parents identify at least four behavioral difficulties of the child occurring at home that they want to target in the training, based on a specified list of 29 behaviors
Not Eligible

You will not qualify if you...

  • The child is currently using psychotropic medication or has used any in the month before screening
  • The child has ever received a diagnosis of autism spectrum disorder (ASD)
  • The child has a known IQ score below 70
  • Parents have received behavioral parent training aimed at reducing the child's behavioral difficulties in the year prior to the study
  • It is not a suitable period for the parents or child to participate (e.g., moving, divorce)
  • The child does not live in the same household as the participating parent(s) for at least four weekdays

AI-Screening

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Trial Site Locations

Total: 1 location

1

Accare

Groningen, Netherlands, 9723 HE

Actively Recruiting

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Research Team

R

Roos S. van Doornik, MSc.

CONTACT

T

Tycho J. Dekkers, dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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