NCT05539170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2025

Completed
Last Updated

August 14, 2025

Status Verified

April 1, 2025

Enrollment Period

2.3 years

First QC Date

September 6, 2022

Last Update Submit

August 11, 2025

Conditions

Keywords

differential susceptibilityparentingintervention efficacyrandomized controlled microtrial

Outcome Measures

Primary Outcomes (3)

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

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

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

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

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

    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.

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

Secondary Outcomes (2)

  • 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)

  • 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)

Study Arms (2)

"micro" parenting intervention

EXPERIMENTAL

Parents will be instructed to bring the completed questionnaires with them to the university lab. Then, in the lab, parents will be observed interacting with their child. Following these baseline conditions, half of the parents will receive the "micro" parenting intervention-in the form of individual positive feedback concerning their parenting and their child's behavior.

Behavioral: Immediate positive parenting feedback

care-as-usual condition

NO INTERVENTION

Participants in the care-as-usual control condition receive no immediate positive parenting feedback but will also be taken aside without their child, receiving only the instructions of the experiment.

Interventions

Individual positive feedback concerning their parenting and their child's behavior.

"micro" parenting intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents with children aged 4-6 years.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tilburg School of Social and Behavioral Sciences

Tilburg, 5037 AB, Netherlands

Location

Related Publications (1)

  • Chhangur RR, Belsky J. Parents' differential susceptibility to a "micro" parenting intervention: Rationale and study protocol for a randomized controlled microtrial. PLoS One. 2023 Mar 22;18(3):e0282207. doi: 10.1371/journal.pone.0282207. eCollection 2023.

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rabia R. Chhangur, PhD

    Tilburg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: "micro" parenting intervention vs. care-as-usual control condition
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 14, 2022

Study Start

November 1, 2022

Primary Completion

February 14, 2025

Study Completion

February 14, 2025

Last Updated

August 14, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations