Factorial Optimization Trial to Test Effects of Coping Intervention Components

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety, Depression, Coping Skills, Emotional Problem

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Reappraisal Coping
* Behavioral: Distraction Coping
* Behavioral: Relaxation Coping


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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optimization, parental divorce/separation, interparental conflict, adaptive coping, child mental health