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Parents' Differential Susceptibility to Microtrial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05539170
Enrollment
101
Registered
2022-09-14
Start date
2022-11-01
Completion date
2025-02-14
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Behavior, Parent-Child Relations, Parenting

Keywords

differential susceptibility, parenting, intervention efficacy, randomized controlled microtrial

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.

Interventions

BEHAVIORALImmediate positive parenting feedback

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

Sponsors

Tilburg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

micro parenting intervention vs. care-as-usual control condition

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Parental self-efficacy beliefs assessed with the General Scale of Parental Self-Efficacy Beliefs (GSPSEB) at pretest, posttest and follow-upParenting 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).
Parenting behavior assessed with the short version of the Parental Behavior Scale (PBS-S) at pretest, posttest and follow-upParenting 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.
Observed parenting behavior assessed with the Crowell Parent-Child interaction taks at pretest and posttestParenting 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

MeasureTime frameDescription
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)One subscale assessing the degree to which child externalizing problem is a problem from the 36-item Eyberg Child Behavior Inventory (ECBI) will be used to assess the occurrence of child externalizing problem behavior. This Intensity subscale measures frequency of externalizing behavior in children aged 2 to 16 years and has been shown to be a reliable (screening) instrument (3). Example items are: Does not obey house rules and Whines.
Observed child behavior assessed with the Crowell Parent-Child interaction taks at pretest and posttestChange in child behavior: 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 child scales (i.e., positive affect, persistence/enthusiasms, irritability/negative affect, and noncompliance) 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 child's affective presentation, but also collectively as a total score assessing overall relational functioning.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026