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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05822687
Other study ID # STUDY00016078
Secondary ID K01MH120321
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
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