Clinical trial NCT05822687: Factorial Optimization Trial to Test Effects of Coping Intervention Components
Official title: Promoting Effective Coping by Children Exposed to Post-divorce Interparental Conflict to Reduce Risk for Mental Health Problems
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Coping Skills
Emotional Problem
Keywords: optimization
parental divorce/separation
interparental conflict
adaptive coping
child mental health
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-04-21
Enrollment: 144
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: interparental emotional security
timeFrame: pretest at study entry
measure: interparental emotional security
timeFrame: posttest at one month after completion of the last assigned intervention module
measure: interparental emotional security
timeFrame: follow-up at 3 months after completion of the last assigned intervention module
measure: family emotional security
timeFrame: pretest at study entry
measure: family emotional security
timeFrame: posttest at one month after completion of the last assigned intervention module
measure: family emotional security
timeFrame: follow-up at 3 months after completion of the last assigned intervention module
measure: coping efficacy
timeFrame: pretest at study entry
measure: coping efficacy
timeFrame: posttest at one month after completion of the last assigned intervention module
measure: coping efficacy
timeFrame: follow-up at 3 months after completion of the last assigned intervention module
measure: internalizing problems
timeFrame: pretest at study entry
measure: internalizing problems
timeFrame: posttest at one month after completion of the last assigned intervention module
measure: internalizing problems
timeFrame: follow-up at 3 months after completion of the last assigned intervention module
measure: externalizing problems
timeFrame: pretest at study entry
measure: externalizing problems
timeFrame: posttest at one month after completion of the last assigned intervention module
measure: externalizing problems
timeFrame: follow-up at 3 months after completion of the last assigned intervention module
Secondary outcomes:
measure: Cognitive appraisals - conflict specific
timeFrame: daily (6 weeks)
measure: Cognitive appraisals - general
timeFrame: daily (6 weeks)
measure: Emotional distress
timeFrame: daily (6 weeks)
measure: Physiological arousal
timeFrame: daily (6 weeks)
measure: Coping behaviors - conflict specific
timeFrame: daily (6 weeks)
measure: Coping behaviors - general
timeFrame: daily (6 weeks)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Karey L O'Hara, PhD
role: PRINCIPAL_INVESTIGATOR
References: