Factorial Optimization Trial to Test Effects of Coping Intervention Components

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 9 to 12 years
• All sexes
• No healthy volunteers
• Child

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Anxiety, Depression, Coping Skills, Emotional Problem

Being tested

Education, Reappraisal Coping, Distraction Coping, Relaxation Coping

Keywords

optimization, parental divorce/separation, interparental conflict, adaptive coping, child mental health

Medical subject headings

Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• EducationBehavioural

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

• Reappraisal CopingBehavioural

  This digital module will teach reappraisal coping skills.

• Distraction CopingBehavioural

  This digital module will teach distraction coping skills.

• Relaxation CopingBehavioural

  This digital module will teach relaxation coping skills.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Mean Child-Reported Interparental Emotional Security Score on the SIS-SF at 3-Month Follow-Up

   Child-reported Security in the Interparental Subsystem Scale-Short Form (SIS-SF; Holt et al., 2020). The score is the mean of 17 items rated from 0 (not at all true) to 3 (very true for me). Higher scores indicate greater interparental emotional security (better outcome). The outcome table reports observed scores; factorial analyses adjust for baseline SIS-SF and prespecified covariates.

   Measured: approximately 3 months after posttest

2. Mean Child-Reported Family Emotional Security Score on the SIFS at 3-Month Follow-Up

   Child-reported Security in the Family System Scale (SIFS; Forman \& Davies, 2005). The score is the mean of 24 items rated from 0 (completely disagree) to 3 (completely agree). Higher scores indicate greater family emotional security (better outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline SIFS score and prespecified covariates.

   Measured: approximately 3 months after posttest

3. Mean Child-Reported Coping Efficacy Score on the CES at 3-Month Follow-Up

   Child-reported Coping Efficacy Scale (CES; Sandler et al., 2000). The score is the mean of 7 items rated from 0 (not at all) to 3 (very). Higher scores indicate greater coping efficacy (better outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline CES score and prespecified covariates.

   Measured: approximately 3 months after posttest

4. Mean Child-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up

   Child-reported Brief Problem Monitor (BPM) Internalizing Problems scale. The score is the mean of 6 items rated from 0 (not true) to 2 (very true). Higher scores indicate more internalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline child-reported BPM Internalizing Problems score and prespecified covariates.

   Measured: approximately 3 months after posttest

5. Mean Parent-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up

   Parent-reported Brief Problem Monitor (BPM) Internalizing Problems scale. The score is the mean of 6 items rated from 0 (not true) to 2 (very true). Higher scores indicate more internalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline parent-reported BPM Internalizing Problems score and prespecified covariates.

   Measured: approximately 3 months after posttest

6. Mean Child-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up

   Child-reported Brief Problem Monitor (BPM) Externalizing Problems scale. The score is the mean of 7 items rated from 0 (not true) to 2 (very true). Higher scores indicate more externalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline child-reported BPM Externalizing Problems score and prespecified covariates.

   Measured: approximately 3 months after posttest

7. Mean Parent-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up

   Parent-reported Brief Problem Monitor (BPM) Externalizing Problems scale. The score is the mean of 7 items rated from 0 (not true) to 2 (very true). Higher scores indicate more externalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline parent-reported BPM Externalizing Problems score and prespecified covariates.

   Measured: approximately 3 months after posttest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted21 Apr 2023
2. Study start18 Feb 2023
3. Primary completion30 Mar 2026
4. Study completion30 Mar 2026

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for AnxietyStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.