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Completed

NCT Number: NCT05539170

Parents' Differential Susceptibility to Microtrial

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tilburg School of Social and Behavioral Sciences

Tilburg, 5037 AB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate positive parenting feedback

Behavioral

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

Primary outcomes

  1. 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).

  2. 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.

  3. 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

  1. Child externalizing problem assessed with the Eyberg Child Behavior Inventory (ECBI) at pretest, posttest and follow-up.

    Time frame: 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."

  2. Observed child behavior assessed with the Crowell Parent-Child interaction taks at pretest and posttest

    Time frame: Change 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.

Sponsors and collaborators

Lead sponsor

Tilburg University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2022
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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