- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01407120
15 Year Follow-up of New Beginnings Program for Divorced Families (NBF15)
August 1, 2011 updated by: Arizona State University
Effects of NBP for Children of Divorce 15 Years Later
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85287
- Arizona State University: Prevention Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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])
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mother Program
11 session program focused on parenting skills
|
A preventive intervention for divorced families.
|
|
Experimental: Mother Plus Child Program
11 session Mother Program focused on parenting skills plus 11 session Child program focused on child coping skills
|
A preventive intervention for divorced families.
|
|
No Intervention: Literature Control
Families received books on children's post-divorce adjustment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnosis of mental health disorder
Time Frame: 15 year follow-up
|
Incidence and number of internalizing, externalizing, and substance use disorders with onset of symptoms within the last nine years.
|
15 year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Young Adult Substance Use
Time Frame: 15 year follow-up
|
Frequency of substance use past month, and age of onset of regular drinking.
|
15 year follow-up
|
|
Internalizing and Externalizing Problems
Time Frame: 15 Year follow-up
|
Number of internalizing and externalizing problems during the past 6 months
|
15 Year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sharlene A Wolchik, Ph.D., Arizona State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wolchik SA, Sandler IN, Millsap RE, Plummer BA, Greene SM, Anderson ER, Dawson-McClure SR, Hipke K, Haine RA. Six-year follow-up of preventive interventions for children of divorce: a randomized controlled trial. JAMA. 2002 Oct 16;288(15):1874-81. doi: 10.1001/jama.288.15.1874.
- Wolchik SA, West SG, Sandler IN, Tein JY, Coatsworth D, Lengua L, Weiss L, Anderson ER, Greene SM, Griffin WA. An experimental evaluation of theory-based mother and mother-child programs for children of divorce. J Consult Clin Psychol. 2000 Oct;68(5):843-56.
- Elam KK, Sandler I, Wolchik S, Tein JY. Non-Residential Father-Child Involvement, Interparental Conflict and Mental Health of Children Following Divorce: A Person-Focused Approach. J Youth Adolesc. 2016 Mar;45(3):581-93. doi: 10.1007/s10964-015-0399-5. Epub 2015 Dec 21.
- Luecken LJ, Hagan MJ, Wolchik SA, Sandler IN, Tein JY. A Longitudinal Study of the Effects of Child-Reported Maternal Warmth on Cortisol Stress Response 15 Years After Parental Divorce. Psychosom Med. 2016 Feb-Mar;78(2):163-70. doi: 10.1097/PSY.0000000000000251.
- Herman PM, Mahrer NE, Wolchik SA, Porter MM, Jones S, Sandler IN. Cost-benefit analysis of a preventive intervention for divorced families: reduction in mental health and justice system service use costs 15 years later. Prev Sci. 2015 May;16(4):586-96. doi: 10.1007/s11121-014-0527-6.
- Luecken LJ, Hagan MJ, Mahrer NE, Wolchik SA, Sandler IN, Tein JY. Effects of a prevention program for divorced families on youth cortisol reactivity 15 years later. Psychol Health. 2015;30(7):751-69. doi: 10.1080/08870446.2014.983924. Epub 2014 Dec 3.
- Modecki KL, Hagan MJ, Sandler I, Wolchik SA. Latent profiles of nonresidential father engagement six years after divorce predict long-term offspring outcomes. J Clin Child Adolesc Psychol. 2015;44(1):123-36. doi: 10.1080/15374416.2013.865193. Epub 2014 Jan 31.
- Wolchik SA, Sandler IN, Tein JY, Mahrer NE, Millsap RE, Winslow E, Velez C, Porter MM, Luecken LJ, Reed A. Fifteen-year follow-up of a randomized trial of a preventive intervention for divorced families: effects on mental health and substance use outcomes in young adulthood. J Consult Clin Psychol. 2013 Aug;81(4):660-73. doi: 10.1037/a0033235. Epub 2013 Jun 10.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
July 29, 2011
First Submitted That Met QC Criteria
August 1, 2011
First Posted (Estimate)
August 2, 2011
Study Record Updates
Last Update Posted (Estimate)
August 2, 2011
Last Update Submitted That Met QC Criteria
August 1, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01MH071707-04 (U.S. NIH Grant/Contract)
- 5P30MH068685-05 (U.S. NIH Grant/Contract)
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.
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