15 Year Follow-up of New Beginnings Program for Divorced Families (NCT01407120) | Clinical Trial Compass
CompletedPhase 2/3
15 Year Follow-up of New Beginnings Program for Divorced Families
United States240 participantsStarted 2006-07
Plain-language summary
The project is a 15-year follow-up of 240 young adults whose families participated in an experimental evaluation of the New Beginnings Program (NBP), a preventive intervention for divorced families. The NBP was provided in late childhood; the follow-up occurred in young adulthood. Families were randomly assigned to one of three conditions: mother program (MP), dual-component mother and child program (MPCP), or literature-control (LC) condition. Programs were designed to change several putative mediators of children's post-divorce mental health problems using empirically-supported change strategies. The investigators expected that the NBP would have either main or risk by program interactive effects on mental health and substance use problems and disorders, developmental tasks, parent-young adult relationships, physical health problems, and competencies, such that YAs who participated in NBP will have better functioning than YAs in the control condition. The investigators expected that the NBP will have either main or risk by program interactive effects on mothers' mental health; those in the NBP are expected to have fewer mental health problems than those in the control condition.
Who can participate
Age range
9 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Divorced in past two years
* Female residential parent
* At least one 9-12 year-old child resided (at least 50%) with the mother
* Neither mother nor any child was currently in treatment for mental health problems
* Mother had not remarried nor planned to remarry during the program, and did not have a live-in boyfriend
* Custody was expected to remain stable
* Family resided within an hour drive of program site
* Mother and child could complete assessments in English
* Child was not learning disabled nor in special education
* If diagnosed with attention deficit disorder, child was taking medication
Exclusion Criteria:
* Child scored above 17 on the Children's Depression Inventory (CDI, endorsed an item indicating that s/he wanted to kill her/himself, or scored above the 97th percentile on the Externalizing Subscale (Child Behavior Checklist \[CBCL\])
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.