Factorial Optimization Trial to Test Effects of Coping Intervention Components

N/AActive Not RecruitingNCT05822687

Arizona State University144 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

144

Conditions

Anxiety

Interventions

EducationBEHAVIORAL

This is a constant component; all participants will get a psychoeducation digital module.

Reappraisal CopingBEHAVIORAL

This digital module will teach reappraisal coping skills.

Distraction CopingBEHAVIORAL

This digital module will teach distraction coping skills.

Relaxation CopingBEHAVIORAL

This digital module will teach relaxation coping skills.

Eligibility

Sex: ALLMin age: 9 YearsMax age: 12 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Time frame: pretest at study entry

interparental emotional security

Time frame: posttest at one month after completion of the last assigned intervention module

interparental emotional security

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: follow-up at 3 months after completion of the last assigned intervention module

Secondary Outcomes

Cognitive appraisals - conflict specific

SIS-SF Internal Representations subscale (Holt et al., 2020; 6 items)

Time frame: daily (6 weeks)

Cognitive appraisals - general

Threat and Worry Appraisal Scale (TWAS; Sheets et al., 1996; 6 items)

Time frame: daily (6 weeks)

Emotional distress

SIS-SF Emotional Reactivity subscale (Holt et al., 2020; 3 items)

Time frame: daily (6 weeks)

Physiological arousal

Responses to Stress Questionnaire for Parent Conflict Involuntary Engagement subscale (RSQ-PC; Connor-Smith et al., 2000; 3 items)

Time frame: daily (6 weeks)

Coping behaviors - conflict specific

SIS-SF Involvement subscale (Holt et al., 2020; 3 items)

Time frame: daily (6 weeks)

Coping behaviors - general

RSQ-PC primary control, secondary control, and disengagement coping subscales (Connor-Smith et al., 2000; 15-18 items).

Time frame: daily (6 weeks)

Factorial Optimization Trial to Test Effects of Coping Intervention Components

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes