15 Year Follow-up of New Beginnings Program for Divorced Families (NBF15)
Primary Purpose
Mental Disorder, Substance Use
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
New Beginnings Program
Sponsored by
About this trial
This is an interventional prevention trial for Mental Disorder focused on measuring Prevention, Divorce
Eligibility 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])
Sites / Locations
- Arizona State University: Prevention Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Mother Program
Mother Plus Child Program
Literature Control
Arm Description
11 session program focused on parenting skills
11 session Mother Program focused on parenting skills plus 11 session Child program focused on child coping skills
Families received books on children's post-divorce adjustment
Outcomes
Primary Outcome Measures
Diagnosis of mental health disorder
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
Frequency of substance use past month, and age of onset of regular drinking.
Internalizing and Externalizing Problems
Number of internalizing and externalizing problems during the past 6 months
Full Information
NCT ID
NCT01407120
First Posted
July 29, 2011
Last Updated
August 1, 2011
Sponsor
Arizona State University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01407120
Brief Title
15 Year Follow-up of New Beginnings Program for Divorced Families
Acronym
NBF15
Official Title
Effects of NBP for Children of Divorce 15 Years Later
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Arizona State University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder, Substance Use
Keywords
Prevention, Divorce
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mother Program
Arm Type
Experimental
Arm Description
11 session program focused on parenting skills
Arm Title
Mother Plus Child Program
Arm Type
Experimental
Arm Description
11 session Mother Program focused on parenting skills plus 11 session Child program focused on child coping skills
Arm Title
Literature Control
Arm Type
No Intervention
Arm Description
Families received books on children's post-divorce adjustment
Intervention Type
Behavioral
Intervention Name(s)
New Beginnings Program
Intervention Description
A preventive intervention for divorced families.
Primary Outcome Measure Information:
Title
Diagnosis of mental health disorder
Description
Incidence and number of internalizing, externalizing, and substance use disorders with onset of symptoms within the last nine years.
Time Frame
15 year follow-up
Secondary Outcome Measure Information:
Title
Young Adult Substance Use
Description
Frequency of substance use past month, and age of onset of regular drinking.
Time Frame
15 year follow-up
Title
Internalizing and Externalizing Problems
Description
Number of internalizing and externalizing problems during the past 6 months
Time Frame
15 Year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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])
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharlene A Wolchik, Ph.D.
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University: Prevention Research Center
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12377086
Citation
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.
Results Reference
background
PubMed Identifier
11068970
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.
Results Reference
background
PubMed Identifier
26692236
Citation
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.
Results Reference
derived
PubMed Identifier
26465217
Citation
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.
Results Reference
derived
PubMed Identifier
25382415
Citation
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.
Results Reference
derived
PubMed Identifier
25367835
Citation
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.
Results Reference
derived
PubMed Identifier
24484456
Citation
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.
Results Reference
derived
PubMed Identifier
23750466
Citation
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.
Results Reference
derived
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15 Year Follow-up of New Beginnings Program for Divorced Families
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