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Clinical Trials/NCT05539170
NCT05539170
Completed
N/A

Parents' Differential Susceptibility to a Randomized Controlled Microtrial: The Role of Physiological Signals as Underlying Mechanism

Tilburg University1 site in 1 country101 target enrollmentNovember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parenting
Sponsor
Tilburg University
Enrollment
101
Locations
1
Primary Endpoint
Parenting behavior assessed with the short version of the Parental Behavior Scale (PBS-S) at pretest, posttest and follow-up
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

This randomized controlled microtrial, not just focus on parental (and child) responsiveness but also on an underlying physiological mechanism hypothesized to contribute to heightened susceptibility to parenting interventions.

Detailed Description

After being informed about the study, all participants giving written informed consent will be randomly assigned to the "micro" intervention condition (i.e., immediate positive parenting feedback) or care-as-usual control condition in a singe-blind manner in a 1:1 ratio.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
February 14, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tilburg University
Responsible Party
Principal Investigator
Principal Investigator

Rabia Chhangur

Assistant professor

Tilburg University

Eligibility Criteria

Inclusion Criteria

  • Parents with children aged 4-6 years.

Exclusion Criteria

  • psychiatric/neurological disorder (as reported by the parent)
  • mental retardation (IQ \< 70)
  • not mastering the Dutch language, and
  • that their child is not living in another household during the weekdays

Outcomes

Primary Outcomes

Parenting behavior assessed with the short version of the Parental Behavior Scale (PBS-S) at pretest, posttest and follow-up

Time Frame: Parenting change: baseline (pretest), after 2 weeks (posttest), and after 4 weeks (follow-up)

This questionnaire consists of 25 items and comprises five subscales: Positive parenting (e.g., "I make time to listen to my child, when he/she wants to tell me something"), Discipline (e.g., "When my child has been disobedient, I give him/her a chore as punishment"), Harsh Punishment (e.g., "I spank my child when he/she is disobedient or naughty"), Material Rewarding (e.g., "I give my child candy as a reward for good behavior"), and Rule Setting (e.g., "I teach my child to be polite at school"). A 5-point scale is provided for each item, ranging from 1 = (almost) never to 5 = (almost) always.

Parental self-efficacy beliefs assessed with the General Scale of Parental Self-Efficacy Beliefs (GSPSEB) at pretest, posttest and follow-up

Time Frame: Parenting change: baseline (pretest), after 2 weeks (posttest), and after 4 weeks (follow-up)

This 25-item scale is related to five domain-specific SEB factors: Discipline, Nurturance, Playing, Instrumental Care, and Teaching. Self-efficacy beliefs in parenting can be evaluated as a quantitative construct by asking parents their beliefs in specific parenting activities, such as teaching, playing, providing instrumental care, nurturing or disciplining their child. Items are in the form of affirmatives, for example: ''I am able to sense when my child is starting to become distressed'' for the Nurturance subscale. The items will be rated on a 5-point scale (1 = strongly disagree to 5 = strongly agree).

Observed parenting behavior assessed with the Crowell Parent-Child interaction taks at pretest and posttest

Time Frame: Parenting change: baseline/pretest observation at lab (before intervention) and posttest observation at same labvisit (after intervention)

The Crowell observation task takes 20 minutes to complete and consists of four episodes: warm-up, free play, frustration task, and recovery time. The parent scales (i.e., positive affect, autonomy support, negative affect, withdrawal, controlling behavior and laxness/inconsistent) are each internally consistent and well-defined conceptually. High internal consistency for each scale provides support for the reliability of the rating scale, and suggests that the Crowell scores can be useful as scale to measure caregiver responsiveness, but also collectively as a total score assessing overall relational functioning.

Secondary Outcomes

  • Observed child behavior assessed with the Crowell Parent-Child interaction taks at pretest and posttest(Change in child behavior: baseline/pretest observation at lab (before intervention) and posttest observation at same labvisit (after intervention))
  • Child externalizing problem assessed with the Eyberg Child Behavior Inventory (ECBI) at pretest, posttest and follow-up.(Change in child behavior: baseline (pretest), after 2 weeks (posttest), and after 4 weeks (follow-up))

Study Sites (1)

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