Clinical trial NCT05539170: Parents' Differential Susceptibility to Microtrial
Official title: Parents' Differential Susceptibility to a Randomized Controlled Microtrial: The Role of Physiological Signals as Underlying Mechanism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parenting
Child Behavior
Parent-Child Relations
Keywords: differential susceptibility
parenting
intervention efficacy
randomized controlled microtrial
Lead sponsor: Tilburg University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: "micro" parenting intervention vs. care-as-usual control condition
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parental self-efficacy beliefs assessed with the General Scale of Parental Self-Efficacy Beliefs (GSPSEB) at pretest, posttest and follow-up
timeFrame: Parenting change: baseline (pretest), after 2 weeks (posttest), and after 4 weeks (follow-up)
measure: Parenting behavior assessed with the short version of the Parental Behavior Scale (PBS-S) at pretest, posttest and follow-up
timeFrame: Parenting change: baseline (pretest), after 2 weeks (posttest), and after 4 weeks (follow-up)
measure: Observed parenting behavior assessed with the Crowell Parent-Child interaction taks at pretest and posttest
timeFrame: Parenting change: baseline/pretest observation at lab (before intervention) and posttest observation at same labvisit (after intervention)
Secondary outcomes:
measure: Child externalizing problem assessed with the Eyberg Child Behavior Inventory (ECBI) at pretest, posttest and follow-up.
timeFrame: Change in child behavior: baseline (pretest), after 2 weeks (posttest), and after 4 weeks (follow-up)
measure: Observed child behavior assessed with the Crowell Parent-Child interaction taks at pretest and posttest
timeFrame: Change in child behavior: baseline/pretest observation at lab (before intervention) and posttest observation at same labvisit (after intervention)
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: Tilburg School of Social and Behavioral Sciences
Study officials:
affiliation: Tilburg University
name: Rabia R. Chhangur, PhD
role: PRINCIPAL_INVESTIGATOR
References: