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

Substance Use Clinical Trial

— NBF15  

Official title:

Effects of NBP for Children of Divorce 15 Years Later

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407120
• Other study ID #: 5R01MH071707-04
• Secondary ID: 5P30MH068685-05
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 29, 2011
• Last updated: August 1, 2011
• Start date: July 2006
• Est. completion date: September 2009

Study information

• Verified date: July 2011
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders
• Psychotic Disorders
• Substance Use

Intervention

Behavioral:
• New Beginnings Program
A preventive intervention for divorced families.

Locations

Country	Name	City	State
United States	Arizona State University: Prevention Research Center	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of mental health disorder	Incidence and number of internalizing, externalizing, and substance use disorders with onset of symptoms within the last nine years.	15 year follow-up	No
Secondary	Young Adult Substance Use	Frequency of substance use past month, and age of onset of regular drinking.	15 year follow-up	No
Secondary	Internalizing and Externalizing Problems	Number of internalizing and externalizing problems during the past 6 months	15 Year follow-up	No