Factorial Optimization Trial to Test Effects of Coping Intervention Components

Promoting Effective Coping by Children Exposed to Post-divorce Interparental Conflict to Reduce Risk for Mental Health Problems

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Coping Skills; Emotional Problem
• Intervention / Treatment: Behavioral: Education; Behavioral: Reappraisal Coping; Behavioral: Distraction Coping; Behavioral: Relaxation Coping

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 Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85087
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education; Participants will complete an educational digital module and no skills-based digital modules.	Behavioral: Education; This is a constant component; all participants will get a psychoeducation digital module.
Experimental: Education + Reappraisal; Participants will complete an educational digital module and a skills-based digital module that teaches reappraisal coping.	Behavioral: Education; This is a constant component; all participants will get a psychoeducation digital module.; Behavioral: Reappraisal Coping; This digital module will teach reappraisal coping skills.
Experimental: Education + Distraction; Participants will complete an educational digital module and a skills-based digital module that teaches distraction coping.	Behavioral: Education; This is a constant component; all participants will get a psychoeducation digital module.; Behavioral: Distraction Coping; This digital module will teach distraction coping skills.
Experimental: Education + Relaxation; Participants will complete an educational digital module and a skills-based digital module that teaches relaxation coping.	Behavioral: Education; This is a constant component; all participants will get a psychoeducation digital module.; Behavioral: Relaxation Coping; This digital module will teach relaxation coping skills.
Experimental: Education + Reappraisal + Distraction; Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches distraction coping.	Behavioral: Education; This is a constant component; all participants will get a psychoeducation digital module.; Behavioral: Reappraisal Coping; This digital module will teach reappraisal coping skills.; Behavioral: Distraction Coping; This digital module will teach distraction coping skills.
Experimental: Education + Reappraisal + Relaxation; Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches relaxation coping.	Behavioral: Education; This is a constant component; all participants will get a psychoeducation digital module.; Behavioral: Reappraisal Coping; This digital module will teach reappraisal coping skills.; Behavioral: Relaxation Coping; This digital module will teach relaxation coping skills.
Experimental: Education + Distraction + Relaxation; Participants will complete an educational digital module and two skills-based digital modules, one that teaches distraction coping and one that teaches relaxation coping.	Behavioral: Education; This is a constant component; all participants will get a psychoeducation digital module.; Behavioral: Distraction Coping; This digital module will teach distraction coping skills.; Behavioral: Relaxation Coping; This digital module will teach relaxation coping skills.
Experimental: Education + Reappraisal + Distraction + Relaxation; 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.	Behavioral: Education; This is a constant component; all participants will get a psychoeducation digital module.; Behavioral: Reappraisal Coping; This digital module will teach reappraisal coping skills.; Behavioral: Distraction Coping; This digital module will teach distraction coping skills.; Behavioral: Relaxation Coping; This digital module will teach relaxation coping skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
interparental emotional security	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	pretest at study entry
interparental emotional security	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	posttest at one month after completion of the last assigned intervention module
interparental emotional security	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	follow-up at 3 months after completion of the last assigned intervention module
family emotional security	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	pretest at study entry
family emotional security	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	posttest at one month after completion of the last assigned intervention module
family emotional security	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	follow-up at 3 months after completion of the last assigned intervention module
coping efficacy	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	pretest at study entry
coping efficacy	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	posttest at one month after completion of the last assigned intervention module
coping efficacy	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	follow-up at 3 months after completion of the last assigned intervention module
internalizing problems	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	pretest at study entry
internalizing problems	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	posttest at one month after completion of the last assigned intervention module
internalizing problems	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	follow-up at 3 months after completion of the last assigned intervention module
externalizing problems	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	pretest at study entry
externalizing problems	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	posttest at one month after completion of the last assigned intervention module
externalizing problems	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	follow-up at 3 months after completion of the last assigned intervention module

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Karey L O'Hara, PhD, Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2023
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: April 8, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: optimization; parental divorce/separation; interparental conflict; adaptive coping; child mental health
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: STUDY00016078; K01MH120321 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study results will be shared through presentations at conferences and submissions in peer-reviewed journals. In addition, after taking all steps necessary to minimize possible re-identification of confidential data, I will make data, codebooks, and analysis scripts available to appropriate parties to verify findings and conclusions.
• IPD Sharing Time Frame: one year post data collection
• IPD Sharing Access Criteria: qualified researchers who have gained IRB approval and pre-registered their analyses
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No