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

NCT06160193 | Unknown

• 2 other identifiers: METc 2023/359PPO-RF-32
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.The longer-term outcomes (three month follow-up) of the brief parent training program on primary and secondary outcomes.
4. 4.The satisfaction and acceptability of the brief parent training program in primary care settings as perceived by parents and child mental health workers.

Conditions

Behavioral Difficulties

Keywords

Parent Training; Behavioral Parent Training; Brief Parent Training; Individually-Tailored; Behavioral Difficulties; Disruptive Behavior; Behavior Problems; Children; Randomized Controlled Trial; Brief Treatment; Primary Care Setting; Primary Care; General Practitioners' Practices; Behavioral Problems; Problem Behaviors

Outcome Measures

Primary Outcomes (1)

• Severity of four daily rated target behaviors in specific home situations

  The primary outcome will be the severity of four parent-rated target behaviors. Parents select four daily occurring behavioral difficulties of the child at home and specific situations in which these behaviors occur. Target behaviors will be selected from an adapted version of a list of 29 possible target behaviors (Hornstra et al., 2021; Van den Hoofdakker et al., 2007), of which parents indicate daily occurrence (yes/no) and (if yes) the severity on a 5-point Likert scale from 1 (not severe) to 5 (extremely severe). Specific situations will be selected from the Home Situation Questionnaire (Breen \& Altepeter, 1991). The severity of the four target behaviors within specific situations will be measured with brief daily telephone calls on at least four consecutive school days by the researchers. Parents will be asked whether the four selected target behaviors occurred in the past 24 hours in the selected situation (yes/no) and (if yes) rate the severity on a 5-point Likert scale.

  Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).

Secondary Outcomes (8)

• Severity of the same four daily rated target behaviors in other home situations than the specified situation which is used as primary outcome (see primary outcome measure for details on administration)

  Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).

• Parent-reported severity of child disruptive behaviors

  Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).

• Parent-reported number of child disruptive behaviors that parents consider as troublesome

  Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).

• Parent-reported overall impairment of child behavioral difficulties

  Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).

• Parent-reported impact of child behavioral difficulties on the relationship with parents

  Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (experimental arm only) (T2).

Other Outcomes (6)

• Parents' satisfaction with and opinion about the program

  One week after the brief training (experimental arm only) (T1).

• Parents' opinions about the acceptability of the program

  After the inclusion of participants in the trial is finished, which is anticipated to be in September 2025.

• Child mental health workers' satisfaction with and opinion about the program

  After the inclusion of participants in the trial is finished, which is anticipated to be in September 2025.

Study Arms (2)

Brief behavioral parent training with optional care as usual

EXPERIMENTAL

A brief, individualized, three-session parent training that exists of two (bi)weekly individually tailored training sessions of 120 minutes, and a third session of 60 minutes. Parents and children may receive care as usual as well. 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.

Behavioral: Brief behavioral parent training with optional care as usual; Other: Care as usual

Care as usual only

ACTIVE COMPARATOR

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.

Other: Care as usual

Interventions

Brief behavioral parent training with optional care as usual BEHAVIORAL

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.

Also known as: The PAINT-P program, Brief parent training

Brief behavioral parent training with optional care as usual

Care as usual OTHER

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.

Also known as: CAU

Brief behavioral parent training with optional care as usual; Care as usual only

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child is aged 2 to (until and including) 11 years old;
• Parents have to identify at least four behavioral difficulties of the child at home that they want to target in the training (using the list of 29 target behavioral difficulties (Van den Hoofdakker 2007; Hornstra et al., 2021)).

You may not qualify if:

• Current psychotropic medication use of the child (at least not in the month before the training);
• The child has a diagnosis of autism spectrum disorder (as reported by parents, we will not perform any measures to assess autism spectrum disorder);
• The child has an IQ-score of less than 70 (as reported by parents, we will not perform any measures to determine the IQ-score);
• Parents received support or training aimed at remediating behavioral difficulties of the concerned child in the year before the study;
• Not a suitable period for the parents and/or the child to participate in the study (e.g., moving, divorce);
• The child is not living in the same household during at least four weekdays, to ensure that that parent(s) are able to practice the techniques with their child during the week.

Sponsors & Collaborators

• Accare: lead

Study Sites (1)

Accare

Groningen, 9723HE, Netherlands

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Problem Behavior; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Barbara J. van den Hoofdakker, Prof. dr.

  Accare Child Study Center; University Medical Center Groningen; University of Groningen

  PRINCIPAL INVESTIGATOR

• Saskia van der Oord, Prof. dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique P.A. Doffer, MSc.

CONTACT

+31659819895; d.doffer@accare.nl

Tycho J. Dekkers, Dr.

CONTACT

t.dekkers@accare.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will conduct a two-armed randomized controlled trial. Children and their parents will be randomly assigned (simple and parallel randomization) to (a) the intervention condition in which parents receive the brief parent training and may receive care as usual, or (b) the control condition in which parents may receive care as usual only.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: January 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-01

Locations

NL (1)