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Factorial Optimization Trial to Test Effects of Coping Intervention Components

Primary Purpose

Anxiety, Depression, Coping Skills

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Reappraisal Coping
Distraction Coping
Relaxation Coping
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring optimization, parental divorce/separation, interparental conflict, adaptive coping, child mental health

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept 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)

Sites / Locations

  • Arizona State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Education

Education + Reappraisal

Education + Distraction

Education + Relaxation

Education + Reappraisal + Distraction

Education + Reappraisal + Relaxation

Education + Distraction + Relaxation

Education + Reappraisal + Distraction + Relaxation

Arm Description

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

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

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

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

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

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

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

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2023
Last Updated
April 8, 2023
Sponsor
Arizona State University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05822687
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Coping Skills, Emotional Problem
Keywords
optimization, parental divorce/separation, interparental conflict, adaptive coping, child mental health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education
Arm Type
Experimental
Arm Description
Participants will complete an educational digital module and no skills-based digital modules.
Arm Title
Education + Reappraisal
Arm Type
Experimental
Arm Description
Participants will complete an educational digital module and a skills-based digital module that teaches reappraisal coping.
Arm Title
Education + Distraction
Arm Type
Experimental
Arm Description
Participants will complete an educational digital module and a skills-based digital module that teaches distraction coping.
Arm Title
Education + Relaxation
Arm Type
Experimental
Arm Description
Participants will complete an educational digital module and a skills-based digital module that teaches relaxation coping.
Arm Title
Education + Reappraisal + Distraction
Arm Type
Experimental
Arm 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.
Arm Title
Education + Reappraisal + Relaxation
Arm Type
Experimental
Arm 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.
Arm Title
Education + Distraction + Relaxation
Arm Type
Experimental
Arm 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.
Arm Title
Education + Reappraisal + Distraction + Relaxation
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
This is a constant component; all participants will get a psychoeducation digital module.
Intervention Type
Behavioral
Intervention Name(s)
Reappraisal Coping
Intervention Description
This digital module will teach reappraisal coping skills.
Intervention Type
Behavioral
Intervention Name(s)
Distraction Coping
Intervention Description
This digital module will teach distraction coping skills.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Coping
Intervention Description
This digital module will teach relaxation coping skills.
Primary Outcome Measure Information:
Title
interparental emotional security
Description
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
Title
interparental emotional security
Description
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
posttest at one month after completion of the last assigned intervention module
Title
interparental emotional security
Description
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
follow-up at 3 months after completion of the last assigned intervention module
Title
family emotional security
Description
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
Title
family emotional security
Description
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
Title
family emotional security
Description
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
Title
coping efficacy
Description
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
Title
coping efficacy
Description
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
Title
coping efficacy
Description
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
Title
internalizing problems
Description
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
Title
internalizing problems
Description
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
Title
internalizing problems
Description
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
Title
externalizing problems
Description
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
Title
externalizing problems
Description
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
Title
externalizing problems
Description
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 Outcome Measure Information:
Title
Cognitive appraisals - conflict specific
Description
SIS-SF Internal Representations subscale (Holt et al., 2020; 6 items)
Time Frame
daily (6 weeks)
Title
Cognitive appraisals - general
Description
Threat and Worry Appraisal Scale (TWAS; Sheets et al., 1996; 6 items)
Time Frame
daily (6 weeks)
Title
Emotional distress
Description
SIS-SF Emotional Reactivity subscale (Holt et al., 2020; 3 items)
Time Frame
daily (6 weeks)
Title
Physiological arousal
Description
Responses to Stress Questionnaire for Parent Conflict Involuntary Engagement subscale (RSQ-PC; Connor-Smith et al., 2000; 3 items)
Time Frame
daily (6 weeks)
Title
Coping behaviors - conflict specific
Description
SIS-SF Involvement subscale (Holt et al., 2020; 3 items)
Time Frame
daily (6 weeks)
Title
Coping behaviors - general
Description
RSQ-PC primary control, secondary control, and disengagement coping subscales (Connor-Smith et al., 2000; 15-18 items).
Time Frame
daily (6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karey L O'Hara, PhD
Phone
4807276136
Email
klohara@asu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sharlene A Wolchik, PhD
Email
wolchik@asu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karey L O'Hara, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85087
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karey O'Hara, PhD
Phone
480-727-3623
Email
klohara@asu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results will be shared through presentations at conferences and submissions in peer-reviewed journals. In addition, after taking all steps necessary to minimize possible re-identification of confidential data, I will make data, codebooks, and analysis scripts available to appropriate parties to verify findings and conclusions.
IPD Sharing Time Frame
one year post data collection
IPD Sharing Access Criteria
qualified researchers who have gained IRB approval and pre-registered their analyses

Learn more about this trial

Factorial Optimization Trial to Test Effects of Coping Intervention Components

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