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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Arizona State University
ClinicalTrials.gov Identifier:
NCT01407120
First received: July 29, 2011
Last updated: August 1, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Mental Disorder
Substance Use
 Behavioral: New Beginnings Program
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of NBP for Children of Divorce 15 Years Later

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arizona State University:

Primary Outcome Measures:
  • Diagnosis of mental health disorder [ Time Frame: 15 year follow-up ] [ Designated as safety issue: No ]
    Incidence and number of internalizing, externalizing, and substance use disorders with onset of symptoms within the last nine years.


Secondary Outcome Measures:
  • Young Adult Substance Use [ Time Frame: 15 year follow-up ] [ Designated as safety issue: No ]
    Frequency of substance use past month, and age of onset of regular drinking.

  • Internalizing and Externalizing Problems [ Time Frame: 15 Year follow-up ] [ Designated as safety issue: No ]
    Number of internalizing and externalizing problems during the past 6 months


Enrollment: 240
Study Start Date: July 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   9 Years to 12 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407120

Locations
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
Principal Investigator: Sharlene A Wolchik, Ph.D. Arizona State University
  More Information

Additional Information:
Prevention Research Center Website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Sharlene Wolchik/ Professor, Arizona State University
ClinicalTrials.gov Identifier: NCT01407120     History of Changes
Other Study ID Numbers: 5R01MH071707-04, 5P30MH068685-05
Study First Received: July 29, 2011
Last Updated: August 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Arizona State University:
Prevention
Divorce

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 21, 2013