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
2 other identifiers
interventional
148
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable anxiety
Started Feb 2023
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2023
CompletedStudy Start
First participant enrolled
February 18, 2023
CompletedFirst Posted
Study publicly available on registry
April 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedApril 29, 2026
April 1, 2026
3.1 years
February 17, 2023
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
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 Outcomes (6)
Cognitive appraisals - conflict specific
daily (6 weeks)
Cognitive appraisals - general
daily (6 weeks)
Emotional distress
daily (6 weeks)
Physiological arousal
daily (6 weeks)
Coping behaviors - conflict specific
daily (6 weeks)
- +1 more secondary outcomes
Study Arms (8)
Education
EXPERIMENTALParticipants will complete an educational digital module and no skills-based digital modules.
Education + Reappraisal
EXPERIMENTALParticipants will complete an educational digital module and a skills-based digital module that teaches reappraisal coping.
Education + Distraction
EXPERIMENTALParticipants will complete an educational digital module and a skills-based digital module that teaches distraction coping.
Education + Relaxation
EXPERIMENTALParticipants will complete an educational digital module and a skills-based digital module that teaches relaxation coping.
Education + Reappraisal + Distraction
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
This is a constant component; all participants will get a psychoeducation digital module.
This digital module will teach reappraisal coping skills.
This digital module will teach distraction coping skills.
This digital module will teach relaxation coping skills.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arizona State University
Tempe, Arizona, 85087, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karey L O'Hara, PhD
Arizona State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 17, 2023
First Posted
April 21, 2023
Study Start
February 18, 2023
Primary Completion
March 30, 2026
Study Completion
March 30, 2026
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- one year post data collection
- Access Criteria
- qualified researchers who have gained IRB approval and pre-registered their analyses
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.