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Completed

NCT Number: NCT05822687

Factorial Optimization Trial to Test Effects of Coping Intervention Components

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Coping Skills Depression Emotional Problem Mental Disorders

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Tempe, Arizona, 85087, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Education

Behavioral

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

Reappraisal Coping

Behavioral

This digital module will teach reappraisal coping skills.

Distraction Coping

Behavioral

This digital module will teach distraction coping skills.

Relaxation Coping

Behavioral

This digital module will teach relaxation coping skills.

Primary outcomes

  1. interparental emotional security

    Time frame: pretest at study entry

    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

  2. interparental emotional security

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

    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

  3. interparental emotional security

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

    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

  4. family emotional security

    Time frame: pretest at study entry

    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

  5. family emotional security

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

    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

  6. family emotional security

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

    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

  7. coping efficacy

    Time frame: pretest at study entry

    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

  8. coping efficacy

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

    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

  9. coping efficacy

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

    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

  10. internalizing problems

    Time frame: pretest at study entry

    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

  11. internalizing problems

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

    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

  12. internalizing problems

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

    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

  13. externalizing problems

    Time frame: pretest at study entry

    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

  14. externalizing problems

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

    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

  15. externalizing problems

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

    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 outcomes

  1. Cognitive appraisals - conflict specific

    Time frame: daily (6 weeks)

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

  2. Cognitive appraisals - general

    Time frame: daily (6 weeks)

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

  3. Emotional distress

    Time frame: daily (6 weeks)

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

  4. Physiological arousal

    Time frame: daily (6 weeks)

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

  5. Coping behaviors - conflict specific

    Time frame: daily (6 weeks)

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

  6. Coping behaviors - general

    Time frame: daily (6 weeks)

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

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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