- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06840431
Randomized Control Trial of the Co-Parenting for Resilience Program (CPR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Reducing the effects of parental divorce on children is a clear but often overlooked public health issue. Nearly 44% of the 66 million children living in the U.S. will experience their parents' divorce or separation by age 15. Because children whose parents divorce are more likely to develop social, emotional, behavioral and physical problems and have lower academic performance than their peers from intact families; and because more children of divorce (25%) are diagnosed with mental illness compared to children in the general population (10%), addressing the negative impacts of divorce on children is a national imperative.
Parental management of the divorce process has been shown to be key in determining child adjustment, with greater mismanagement and conflict associated with multiple negative outcomes for children. Divorce can create considerable turmoil in people's lives leading some parents to mishandle their own emotions. Highly emotional parents often place their children in the middle of their conflict, overly rely on children to meet their own emotional needs, or practice avoidance coping through alcohol and drugs or by otherwise abandoning their children. Divorce education programs claiming to help parents ameliorate the effects of divorce on children abound in all 50 states; and over half of states mandate attendance by statute. However, recent reviews reveal major weaknesses in program development and evaluation, such as: (a) few programs are guided by theories of behavior change and only seek to increase knowledge; (b) the majority of programs have not been evaluated, and those that have lack methodological rigor; (c) child outcomes are rarely assessed either directly or indirectly through parent report, (d) important moderators to help determine for whom the program is effective (e.g., parent gender and ethnicity, low- vs. high-conflict couples, reasons for divorce) have not been explored; and (e) although online programs proliferated during COVID-19, they have largely not been tested. Addressing these and other weaknesses is critical to making scientific progress in the field and to developing programs with demonstrated efficacy in helping the millions of parents and children avoid the more severe effects of divorce.
The Co-Parenting for Resilience (CPR) program innovatively merges research from Family Therapy and Prevention Science to address many of the above-mentioned weaknesses. CPR is a 4-hour psychoeducational intervention that draws from empirically supported approaches such as Brief Strategic Family Therapy, Motivational Interviewing, and Family Stress Theory, and uses a combination of instruction, interactive activities, and guided reflections to promote the deep learning and paradigm shifts that aid in changing maladaptive cognitions and in promoting effective parenting and improved child outcomes. Initial findings from a pilot study suggest that CPR reduces parent reports of conflict and stress and increases parental collaboration, hope, and parent reports of child adjustment. These findings, however, were based on a quasi-experimental design with a non-equivalent control group. The proposed R15 project advances the science by leveraging a long-standing partnership with the Oklahoma County District Court to conduct a 3-arm RCT that will accomplish three specific aims:
- Determine the relative efficacy of the online and in-person versions of CPR to improve child post-divorce adjustment compared to each other and to a bibliotherapy control group at 3- and 12-month follow-ups.
- Test paths from the online and in-person versions of CPR to child adjustment via parenting competencies.
- Identify moderators of the effectiveness of in-person and online formats of CPR such as parent gender, ethnicity, and level and type of conflict between divorcing partners.
Primary hypotheses tested are that the effects of CPR on child post-divorce adjustment will: (H1) be higher in both CPR conditions relative to the control group; (H2) not differ between the two CPR conditions; (H3) be mediated by parenting competencies, and (H4) there will be moderation by level and type of conflict.
We will randomly assign 300 unique individuals (not couples) who have filed for divorce to one of the three arms (n=100 each arm). Data will be collected at three timepoints: baseline (pre-intervention), at 3-months to test for program efficacy and mediation, and at a 12-month follow-up controlling for baseline. Participants will be parents of either gender who are filing for divorce with a child from 4-10 years old.
Per the R15 mechanism, this project proposes three objectives: (1) to conduct a small-scale research project whose aims address a significant public health issue, the physical and mental health of divorcing parents and their children; (2) to expose graduate and undergraduate students to different phases of the research process; and (3) to expand institutional research capacity.
The project will innovatively: 1) leverage the court system to rigorously answer questions significant to science and to divorcing families, 2) test an online version of the CPR program that will benefit an underserved rural population, 3) inform further program development by identifying key program moderators, and 4) provide critical empirical evidence for the dissemination of the CPR program to other states.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Stillwater, Oklahoma, United States, 74078
- Oklahoma State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- One adult member of a dyad filing for a divorce or legal separation (e.g., non-married couples) in Oklahoma County with a biological minor child aged 4-10,
- Being an English or Spanish speaker,
- Having internet access necessary for the online group (necessary for this randomized trial.
- In the event participants have more than one child, they will be asked to report on their oldest child with the person they are divorcing who is age 10 or under. Focus on the oldest child counterbalances the age distribution of children expected per our preliminary data, thereby facilitating a test of age differences in treatment effects.
Exclusion Criteria:
- Parents under the age of 18,
- Parents who do not consent to randomization,
- Parents who are illiterate.
- Only one member of the dyad will be allowed in the study.
- We also exclude parents for whom the target child is not the biological child of both parents. Stepfamilies, adoptive families, grandparents raising grandchildren, and other family types have dynamics not directly comparable to families with two biological parents and is beyond the scope of this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: In person condition
This condition tests program effects when delivered by a trained non-clinical facilitator.
|
participants will receive program components in a classroom setting with a trained non-clinical facilitator.
|
|
Experimental: online condition
This condition tests program effects when the program is delivered asynchronously online
|
Participants will receive program components in an asynchronous online format.
|
|
Placebo Comparator: Self-help book with quiz
This condition serves as a placebo control comparing the intervention components to a knowledge only condition.
|
Participants will read a self-help book on how to manage their divorce and take a quiz to ensure that the book has been read.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Baseline, 3-month follow-up, and 12-month follow-up
|
The SDQ is a widely used measure consisting of 25 items that make up five subscales on which parents report their child's emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior.
The SDQ has been normed on children from 4-17 years of age and provides a total child difficulty score and a score for each of the five subscales.
For our primary analyses of child adjustment, we will use the total child difficulty score.
|
Baseline, 3-month follow-up, and 12-month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ronald B Cox, PhD, Oklahoma State University
Publications and helpful links
General Publications
- Sandler I, Gunn H, Mazza G, Tein JY, Wolchik S, Berkel C, Jones S, Porter M. Effects of a Program to Promote High Quality Parenting by Divorced and Separated Fathers. Prev Sci. 2018 May;19(4):538-548. doi: 10.1007/s11121-017-0841-x.
- Cox, R.B., et al., Hope, Stress, and Post-Divorce Child Adjustment: Development and Evaluation of the Co-Parenting for Resilience Program. Journal of Divorce & Remarriage, 2021. 62(2): p. 144-163.
- Hill, R., Generic features of families under stress. Social Casework, 1958. 39(2-3): p. 139-150.
- Hill, R., Families under stress: Adjustment to the crises of war separation and return. 1949.
- Miller, W.R. and S. Rollnick, Motivational interviewing: Helping people change. 2012: Guilford press.
- Fisch, R., J. Weakland, and L. Segal, The tactics of change: Doing therapy briefly. 1982, San Francisco: Jossey-Bass.
- Sigal A, Sandler I, Wolchik S, Braver S. Do Parent Education Programs Promote Healthy Post-Divorce Parenting? Critical Distinctions and a Review of the Evidence. Fam Court Rev. 2011 Jan;49(1):120-139. doi: 10.1111/j.1744-1617.2010.01357.x.
- Kierstead, S., Parent education programs in family courts: Balancing autonomy and state intervention. Family Court Review, 2011. 49(1): p. 140-154.
- Pollet, S.L. and M. Lombreglia, A nationwide survey of mandatory parent education. Family Court Review, 2008. 46(2): p. 375-394.
- Dunn J, Davies LC, O'Connor TG, Sturgess W. Family lives and friendships: the perspectives of children in step-, single-parent, and nonstep families. J Fam Psychol. 2001 Jun;15(2):272-87.
- Amato, P.R., The consequences of divorce for adults and children: An update. Drustvena istrazivanja, 2014. 23(1): p. 5-24.
- Andersson, G., E. Thomson, and A. Duntava, Life-table representations of family dynamics in the 21st century. Demographic Research, 2017. 37: p. 1081-1230.
- Vezzetti VC. New approaches to divorce with children: A problem of public health. Health Psychol Open. 2016 Nov 15;3(2):2055102916678105. doi: 10.1177/2055102916678105. eCollection 2016 Jul.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Oklahoma State University
- 1R15HD112895-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child Wellbeing
-
Penn State UniversityUnited States Air ForceRecruitingParenting | Child Maltreatment | Child WellbeingUnited States
-
University of SussexBrighton & Sussex Medical School; Kavli TrustRecruitingChild Wellbeing | Child Anxiety | Parent Anxiety | Parental WellbeingUnited Kingdom
-
International Care Ministries, PhilippinesCompassion International, United States of AmericaNot yet recruitingChild Development | Child Nutrition, Child Neurobehavioral Development | Academic Attainment | Household and Family | Financial Wellbeing
-
Chinese University of Hong KongXi'an Jiaotong-Liverpool UniversityCompletedWellbeing | Development, Child | MindfulnessHong Kong
-
Uppsala UniversityBielefeld University; Vivo international e.V.; Kabale UniversityActive, not recruitingPsychological Distress | Mental Health | Child Wellbeing | Child Mental HealthUganda
-
Moss KommuneUniversity of Oslo; Norwegian Institute of Public Health; Norwegian Council for...CompletedQuality of Life | Adolescent Health | Child WellbeingNorway
-
Canterbury Christ Church UniversityNot yet recruiting
-
CorStoneIntegrated Development Foundation Nepal; David & Lucile Packard Foundation; Gramin...CompletedEmotional Wellbeing | Social Wellbeing | Physical WellbeingUnited States
-
University of HelsinkiCompletedBurnout | Children's Wellbeing | Child Overall Health Related Quality of LifeFinland
-
George Washington UniversityUniversidad Católica De Colombia; Universidad Católica de Oriente; Fundación...Not yet recruiting
Clinical Trials on in-person condition
-
Mayo ClinicCompletedTelemedicine | Primary Health Care | Diagnosis | Therapeutics | Developing CountriesHonduras
-
University of VermontNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...Completed
-
University of California, DavisCompletedPediatrics | Physical Therapy Modalities | Physical and Rehabilitation MedicineUnited States
-
Norges idrettshøgskoleKristiania University College; ABEL TechnologiesRecruiting
-
Yale UniversityNational Institute of Mental Health (NIMH)Recruiting
-
University of MalayaRecruitingOrthodontic Appliance ComplicationMalaysia
-
University of Electronic Science and Technology...CompletedSexual Infidelity | Emotional Infidelity | JealousyChina
-
Institute of Mountain Emergency MedicineMedical University Innsbruck; University Grenoble Alps; Università degli Studi...CompletedEmergency Medicine | Cognitive Performance | Stress Physiology | Hypobaric Hypoxia | Hypobaric NormoxiaItaly
-
VA Office of Research and DevelopmentUniversity of Pennsylvania; University of HawaiiCompleted
-
University Hospital, MontpellierCompletedHealthy | Heat ExposureFrance