Factorial Optimization Trial to Test Effects of Coping Intervention Components

Not Applicable

Recruiting

• Conditions: Depression; Coping Skills; Anxiety; Emotional Problem
• Interventions: Behavioral: Education; Behavioral: Reappraisal Coping; Behavioral: Distraction Coping; Behavioral: Relaxation Coping

• Registration Number: NCT05822687
• Lead Sponsor: Arizona State University

Brief Summary

This study will identify components for inclusion in a coping intervention package to reduce mental health problems among children exposed to high interparental conflict after parental separation/divorce. Reappraisal, distraction, and relaxation coping strategies are related to fewer mental health problems among children, making intervention components based on these strategies key candidates for inclusion in an optimized coping intervention. The primary aim is to experimentally assess the main and interactive effects of three digital intervention coping components (reappraisal, distraction, relaxation) on children's coping efficacy, emotional security, and internalizing and externalizing problems. Secondary aims are to assess indirect effects of the intervention components on children's coping efficacy, emotional security, and internalizing and externalizing problems through their cognitive, emotional, and behavioral reactions to post-separation/divorce interparental conflict events.

Detailed Description

A randomized and counterbalanced 2x2x2 factorial trial (N = 144 children, ages 9-12) will be conducted to assess the individual effects of the three digital coping intervention components. The three components to be tested will be: (1) Reappraisal (No vs. Yes), (2) Distraction (No vs. Yes), (3) Relaxation (No vs. Yes). Components that meet a priori thresholds for meaningful change will be combined to form an intervention package that will be evaluated in a subsequent randomized controlled trial.

Study Timeline

• Study First Submitted: 2023-02-17
• Study Start: 2023-02-18
• Study First Submitted QC: 2023-04-08
• Study First Posted: 2023-04-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-08-01
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• child between ages 9-12 whose parents are separated or divorced
• child and one parent are fluent in English
• a parent with sufficient contact (i.e., at least 4 overnights and/or 12 daytime visits per month) with child who is willing to complete study assessments and has legal right to give permission for the child to participate in research
• child-report of high exposure to IPC (mean Z score ≥ 40th percentile on the two child report measures of IPC; score standardization based on data from 559 youth whose parents participated in an experimental parenting program)
• elevated internalizing or externalizing problems (T score in the borderline clinical range according to either child or parent report on the BPM).

Exclusion Criteria

• in active therapy
• score ≥ 99th percentile on either internalizing and externalizing problems subscale
• endorse suicidality (will be ineligible for the study and referred for treatment)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Education	Education	Participants will complete an educational digital module and no skills-based digital modules.
Education + Reappraisal	Education	Participants will complete an educational digital module and a skills-based digital module that teaches reappraisal coping.
Education + Distraction	Education	Participants will complete an educational digital module and a skills-based digital module that teaches distraction coping.
Education + Reappraisal + Distraction	Education	Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches distraction coping.
Education + Reappraisal + Relaxation	Education	Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches relaxation coping.
Education + Reappraisal + Distraction + Relaxation	Distraction Coping	Participants will complete an educational digital module and three skills-based digital modules, one that teaches reappraisal coping, one that teaches distraction coping, and one that teaches relaxation coping.
Education + Reappraisal + Distraction	Distraction Coping	Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches distraction coping.
Education + Reappraisal + Relaxation	Relaxation Coping	Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches relaxation coping.
Education + Reappraisal + Distraction	Reappraisal Coping	Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches distraction coping.
Education + Reappraisal + Distraction + Relaxation	Reappraisal Coping	Participants will complete an educational digital module and three skills-based digital modules, one that teaches reappraisal coping, one that teaches distraction coping, and one that teaches relaxation coping.
Education + Reappraisal	Reappraisal Coping	Participants will complete an educational digital module and a skills-based digital module that teaches reappraisal coping.
Education + Distraction	Distraction Coping	Participants will complete an educational digital module and a skills-based digital module that teaches distraction coping.
Education + Relaxation	Education	Participants will complete an educational digital module and a skills-based digital module that teaches relaxation coping.
Education + Relaxation	Relaxation Coping	Participants will complete an educational digital module and a skills-based digital module that teaches relaxation coping.
Education + Reappraisal + Relaxation	Reappraisal Coping	Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches relaxation coping.
Education + Distraction + Relaxation	Education	Participants will complete an educational digital module and two skills-based digital modules, one that teaches distraction coping and one that teaches relaxation coping.
Education + Distraction + Relaxation	Distraction Coping	Participants will complete an educational digital module and two skills-based digital modules, one that teaches distraction coping and one that teaches relaxation coping.
Education + Distraction + Relaxation	Relaxation Coping	Participants will complete an educational digital module and two skills-based digital modules, one that teaches distraction coping and one that teaches relaxation coping.
Education + Reappraisal + Distraction + Relaxation	Education	Participants will complete an educational digital module and three skills-based digital modules, one that teaches reappraisal coping, one that teaches distraction coping, and one that teaches relaxation coping.
Education + Reappraisal + Distraction + Relaxation	Relaxation Coping	Participants will complete an educational digital module and three skills-based digital modules, one that teaches reappraisal coping, one that teaches distraction coping, and one that teaches relaxation coping.

Primary Outcome Measures

Name	Time	Method
interparental emotional security	follow-up at 3 months after completion of the last assigned intervention module	Security in the Interparental Subsystem Scale - Short Form (SIS-SF; Holt et al., 2020) 17 items rated on 4 point scale (0 = not at all true, 3 = very true for me) higher scores indicate better outcome
family emotional security	follow-up at 3 months after completion of the last assigned intervention module	Security in the Family System Scale (SIFS; Forman \& Davies, 2005) 24 items rated on 4 point scale (0 = completely disagree, 3 = completely agree).; higher scores indicate better outcome
coping efficacy	follow-up at 3 months after completion of the last assigned intervention module	Coping Efficacy Scale (CES; Sandler et al., 2000) 7 items rated on 4 point scale (0 = not at all, 3 = very) higher scores indicate better outcome
externalizing problems	follow-up at 3 months after completion of the last assigned intervention module	Brief Problem Monitor (BPM; parent and child report) 7 items rated on a 3 point scale (0= not true, 2 = very true) higher scores indicate worse outcome
internalizing problems	follow-up at 3 months after completion of the last assigned intervention module	Brief Problem Monitor (BPM; parent and child report) 6 items rated on a 3 point scale (0= not true, 2 = very true) higher scores indicate worse outcome

Secondary Outcome Measures

Name	Time	Method
Cognitive appraisals - conflict specific	daily (6 weeks)	SIS-SF Internal Representations subscale (Holt et al., 2020; 6 items)
Cognitive appraisals - general	daily (6 weeks)	Threat and Worry Appraisal Scale (TWAS; Sheets et al., 1996; 6 items)
Emotional distress	daily (6 weeks)	SIS-SF Emotional Reactivity subscale (Holt et al., 2020; 3 items)
Physiological arousal	daily (6 weeks)	Responses to Stress Questionnaire for Parent Conflict Involuntary Engagement subscale (RSQ-PC; Connor-Smith et al., 2000; 3 items)
Coping behaviors - conflict specific	daily (6 weeks)	SIS-SF Involvement subscale (Holt et al., 2020; 3 items)
Coping behaviors - general	daily (6 weeks)	RSQ-PC primary control, secondary control, and disengagement coping subscales (Connor-Smith et al., 2000; 15-18 items).

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Tempe, Arizona, United States