Parents' Differential Susceptibility to Microtrial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parenting, Child Behavior, Parent-Child Relations

Intervention / Treatment
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* Behavioral: Immediate positive parenting feedback


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: micro parenting intervention vs. care-as-usual control condition
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: micro parenting intervention<br>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<br>* Individual positive feedback concerning their parenting and their child's behavior.<br>|
| No Intervention: care-as-usual condition<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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differential susceptibility, parenting, intervention efficacy, randomized controlled microtrial