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15 Year Follow-up of New Beginnings Program for Divorced Families (NBF15)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01407120
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : August 2, 2011
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Arizona State University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Mental Disorder Substance Use Behavioral: New Beginnings Program Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of NBP for Children of Divorce 15 Years Later
Study Start Date : July 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mother Program
11 session program focused on parenting skills
 Behavioral: New Beginnings Program
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
 Behavioral: New Beginnings Program
A preventive intervention for divorced families.
No Intervention: Literature Control
Families received books on children's post-divorce adjustment


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Young Adult Substance Use [ Time Frame: 15 year follow-up ]
    Frequency of substance use past month, and age of onset of regular drinking.

  2. Internalizing and Externalizing Problems [ Time Frame: 15 Year follow-up ]
    Number of internalizing and externalizing problems during the past 6 months


Eligibility Criteria
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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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])
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407120


Locations
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United States, Arizona
Arizona State University: Prevention Research Center
Tempe, Arizona, United States, 85287
Sponsors and Collaborators
Arizona State University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Sharlene A Wolchik, Ph.D. Arizona State University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sharlene Wolchik/ Professor, Arizona State University
ClinicalTrials.gov Identifier: NCT01407120    
Other Study ID Numbers: 5R01MH071707-04 ( U.S. NIH Grant/Contract )
5P30MH068685-05 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2011    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: July 2011
Keywords provided by Arizona State University:
Prevention
Divorce
Additional relevant MeSH terms:
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Mental Disorders