Parents' Differential Susceptibility to Microtrial

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05539170
• Other study ID #: TSB_RP604
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Tilburg University
• Contact: Rabia R. Chhangur, PhD
• Phone: +31134664734
• Email: r.r.chhangur[@]tilburguniversity.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parents with children aged 4-5 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

Related Conditions & MeSH terms

• Child Behavior
• Disease Susceptibility
• Parent-Child Relations
• Parenting

Intervention

Behavioral:
• Immediate positive parenting feedback
Individual positive feedback concerning their parenting and their child's behavior.

Locations

Country	Name	City	State
Netherlands	Tilburg School of Social and Behavioral Sciences	Tilburg

Sponsors (1)

Lead Sponsor	Collaborator
Tilburg University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Child externalizing problem assessed with the Eyberg Child Behavior Inventory (ECBI) at pretest, posttest and 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."	Change in child behavior: baseline (pretest), after 2 weeks (posttest), and after 4 weeks (follow-up)
Secondary	Observed child 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 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.	Change in child behavior: baseline/pretest observation at lab (before intervention) and posttest observation at same labvisit (after intervention)