NCT01407120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
Last Updated

August 2, 2011

Status Verified

July 1, 2011

Enrollment Period

3.2 years

First QC Date

July 29, 2011

Last Update Submit

August 1, 2011

Conditions

Mental DisorderSubstance Use

Keywords

PreventionDivorce

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Young Adult Substance Use

    15 year follow-up

  • Internalizing and Externalizing Problems

    15 Year follow-up

Study Arms (3)

Mother Program

EXPERIMENTAL

11 session program focused on parenting skills

Behavioral: New Beginnings Program

Mother Plus Child Program

EXPERIMENTAL

11 session Mother Program focused on parenting skills plus 11 session Child program focused on child coping skills

Behavioral: New Beginnings Program

Literature Control

NO INTERVENTION

Families received books on children's post-divorce adjustment

Interventions

New Beginnings ProgramBEHAVIORAL

A preventive intervention for divorced families.

Mother Plus Child ProgramMother Program

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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 \[CBCL\])

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University: Prevention Research Center

Tempe, Arizona, 85287, United States

Location

Related Publications (8)

  • 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.

    PMID: 12377086BACKGROUND

  • 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.

    PMID: 11068970BACKGROUND

  • 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.

    PMID: 26692236DERIVED

  • 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.

    PMID: 26465217DERIVED

  • 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.

    PMID: 25382415DERIVED

  • 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.

    PMID: 25367835DERIVED

  • 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.

    PMID: 24484456DERIVED

  • 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.

    PMID: 23750466DERIVED

MeSH Terms

Conditions

Mental DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Sharlene A Wolchik, Ph.D.

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2011

First Posted

August 2, 2011

Study Start

July 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

August 2, 2011

Record last verified: 2011-07

Locations

US(1)