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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85087
- Arizona State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Education
Participants will complete an educational digital module and no skills-based digital modules. |
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. |
This is a constant component; all participants will get a psychoeducation digital module. 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. |
This is a constant component; all participants will get a psychoeducation digital module. 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. |
This is a constant component; all participants will get a psychoeducation digital module. 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. |
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. |
|
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. |
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 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. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach distraction coping skills. 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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Child-Reported Interparental Emotional Security Score on the SIS-SF at 3-Month Follow-Up
Time Frame: approximately 3 months after posttest
|
Child-reported Security in the Interparental Subsystem Scale-Short Form (SIS-SF; Holt et al., 2020). The score is the mean of 17 items rated from 0 (not at all true) to 3 (very true for me). Higher scores indicate greater interparental emotional security (better outcome). The outcome table reports observed scores; factorial analyses adjust for baseline SIS-SF and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Child-Reported Family Emotional Security Score on the SIFS at 3-Month Follow-Up
Time Frame: approximately 3 months after posttest
|
Child-reported Security in the Family System Scale (SIFS; Forman & Davies, 2005). The score is the mean of 24 items rated from 0 (completely disagree) to 3 (completely agree). Higher scores indicate greater family emotional security (better outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline SIFS score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Child-Reported Coping Efficacy Score on the CES at 3-Month Follow-Up
Time Frame: approximately 3 months after posttest
|
Child-reported Coping Efficacy Scale (CES; Sandler et al., 2000). The score is the mean of 7 items rated from 0 (not at all) to 3 (very). Higher scores indicate greater coping efficacy (better outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline CES score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Child-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up
Time Frame: approximately 3 months after posttest
|
Child-reported Brief Problem Monitor (BPM) Internalizing Problems scale. The score is the mean of 6 items rated from 0 (not true) to 2 (very true). Higher scores indicate more internalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline child-reported BPM Internalizing Problems score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Parent-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up
Time Frame: approximately 3 months after posttest
|
Parent-reported Brief Problem Monitor (BPM) Internalizing Problems scale. The score is the mean of 6 items rated from 0 (not true) to 2 (very true). Higher scores indicate more internalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline parent-reported BPM Internalizing Problems score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Child-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up
Time Frame: approximately 3 months after posttest
|
Child-reported Brief Problem Monitor (BPM) Externalizing Problems scale. The score is the mean of 7 items rated from 0 (not true) to 2 (very true). Higher scores indicate more externalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline child-reported BPM Externalizing Problems score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Parent-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up
Time Frame: approximately 3 months after posttest
|
Parent-reported Brief Problem Monitor (BPM) Externalizing Problems scale. The score is the mean of 7 items rated from 0 (not true) to 2 (very true). Higher scores indicate more externalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline parent-reported BPM Externalizing Problems score and prespecified covariates. |
approximately 3 months after posttest
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karey L O'Hara, PhD, Arizona State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00016078
- K01MH120321 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
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