Factorial Optimization Trial to Test Effects of Coping Intervention Components

Arizona State University (ASU)

Status: Active, not recruiting

Conditions: Emotional Problem; Coping Skills; Depression; Anxiety

Treatments: Behavioral: Education; Behavioral: Relaxation Coping; Behavioral: Distraction Coping; Behavioral: Reappraisal Coping

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05822687

STUDY00016078

K01MH120321 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 9 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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144 participants in 8 patient groups

Education

Experimental group

Description:

Participants will complete an educational digital module and no skills-based digital modules.

Treatment:

Behavioral: Education

Education + Reappraisal

Experimental group

Description:

Participants will complete an educational digital module and a skills-based digital module that teaches reappraisal coping.

Treatment:

Behavioral: Reappraisal Coping

Behavioral: Education

Education + Distraction

Experimental group

Description:

Participants will complete an educational digital module and a skills-based digital module that teaches distraction coping.

Treatment:

Behavioral: Distraction Coping

Behavioral: Education

Education + Relaxation

Experimental group

Description:

Participants will complete an educational digital module and a skills-based digital module that teaches relaxation coping.

Treatment:

Behavioral: Relaxation Coping

Behavioral: Education

Education + Reappraisal + Distraction

Experimental group

Description:

Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches distraction coping.

Treatment:

Behavioral: Reappraisal Coping

Behavioral: Distraction Coping

Behavioral: Education

Education + Reappraisal + Relaxation

Experimental group

Description:

Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches relaxation coping.

Treatment:

Behavioral: Reappraisal Coping

Behavioral: Relaxation Coping

Behavioral: Education

Education + Distraction + Relaxation

Experimental group

Description:

Participants will complete an educational digital module and two skills-based digital modules, one that teaches distraction coping and one that teaches relaxation coping.

Treatment:

Behavioral: Distraction Coping

Behavioral: Relaxation Coping

Behavioral: Education

Education + Reappraisal + Distraction + Relaxation

Experimental group

Description:

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.

Treatment:

Behavioral: Reappraisal Coping

Behavioral: Distraction Coping

Behavioral: Relaxation Coping

Behavioral: Education