Factorial Optimization Trial to Test Effects of Coping Intervention Components

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822687
• Other study ID #: STUDY00016078
• Secondary ID: K01MH120321
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: Arizona State University
• Contact: Karey L O'Hara, PhD
• Phone: 4807276136
• Email: klohara[@]asu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Coping Skills
• Depression
• Emotional Problem

Intervention

Behavioral:
• Education
This is a constant component; all participants will get a psychoeducation digital module.
• Reappraisal Coping
This digital module will teach reappraisal coping skills.
• Distraction Coping
This digital module will teach distraction coping skills.
• Relaxation Coping
This digital module will teach relaxation coping skills.

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Cognitive appraisals - conflict specific	SIS-SF Internal Representations subscale (Holt et al., 2020; 6 items)	daily (6 weeks)
Secondary	Cognitive appraisals - general	Threat and Worry Appraisal Scale (TWAS; Sheets et al., 1996; 6 items)	daily (6 weeks)
Secondary	Emotional distress	SIS-SF Emotional Reactivity subscale (Holt et al., 2020; 3 items)	daily (6 weeks)
Secondary	Physiological arousal	Responses to Stress Questionnaire for Parent Conflict Involuntary Engagement subscale (RSQ-PC; Connor-Smith et al., 2000; 3 items)	daily (6 weeks)
Secondary	Coping behaviors - conflict specific	SIS-SF Involvement subscale (Holt et al., 2020; 3 items)	daily (6 weeks)
Secondary	Coping behaviors - general	RSQ-PC primary control, secondary control, and disengagement coping subscales (Connor-Smith et al., 2000; 15-18 items).	daily (6 weeks)