Factorial Optimization Trial to Test Effects of Coping Intervention Components

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT05822687

Acronym / sponsor ID

STUDY00016078

Conditions

Anxiety, Depression, Coping Skills, Emotional Problem

Keywords

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

Study type

Interventional

Recruitment status

Completed

Enrolment

148 participants (actual)

Lead sponsor

Arizona State UniversityUniversity, hospital or other

Collaborators

National Institute of Mental Health (NIMH)

Study start

18 Feb 2023 (actual)

Primary completion

30 Mar 2026 (actual)

Study completion

30 Mar 2026 (actual)

First posted

21 Apr 2023 (actual)

Results

Posted 30 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Factorial

Masking

Single blind (outcomes assessor)

Number of arms

8

Who may qualify

Ages

9 to 12 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

   Time frame: approximately 3 months after posttest

   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.

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

   Time frame: approximately 3 months after posttest

   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.

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

   Time frame: approximately 3 months after posttest

   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.

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

   Time frame: approximately 3 months after posttest

   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.

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

   Time frame: approximately 3 months after posttest

   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.

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

   Time frame: approximately 3 months after posttest

   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.

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

   Time frame: approximately 3 months after posttest

   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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Background: PubMed 38496232O'Hara KL, Wolchik SA, Sandler IN, West SG, Reis HT, Collins LM, Lyon AR, Cummings EM. Preventing Mental Health Problems in Children After High Conflict Parental Separation/Divorce Study: An Optimization Randomized Controlled Trial Protocol. Ment Health Prev. 2023 Dec;32:200301. doi: 10.1016/j.mhp.2023.200301. Epub 2023 Sep 16.
• Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.