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Mental DisorderPhase 2/3NBF15NCT01407120

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

A Phase 2/3 study testing New Beginnings Program in people with Mental Disorder and Substance Use, run by Arizona State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 9 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Mental Disorder, Substance Use
What is being tested?
New Beginnings Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
Jul 2006to Sep 2009
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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])

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Arizona State University: Prevention Research Center

    Tempe, Arizona, 85287

Other trials in United States

About this study

Official title: Effects of NBP for Children of Divorce 15 Years Later

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.

Being tested
New Beginnings Program
Keywords
Prevention, Divorce
Medical subject headings
Mental Disorders, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • New Beginnings ProgramBehavioural

    A preventive intervention for divorced families.

Study groups in NCT01407120
Study groupRoleWhat they receive
Mother ProgramExperimental11 session program focused on parenting skills
Receives: Behavioral: New Beginnings Program
Mother Plus Child ProgramExperimental11 session Mother Program focused on parenting skills plus 11 session Child program focused on child coping skills
Receives: Behavioral: New Beginnings Program
Literature ControlNo interventionFamilies received books on children's post-divorce adjustment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 15 year follow-up

Secondary outcomes (2)

  1. Young Adult Substance Use

    Frequency of substance use past month, and age of onset of regular drinking.

    Measured: 15 year follow-up

  2. Internalizing and Externalizing Problems

    Number of internalizing and externalizing problems during the past 6 months

    Measured: 15 Year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2011 (estimated)
  2. Study startJul 2006
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01407120
Sponsor's protocol ID
5R01MH071707-04
Other IDs
5P30MH068685-05
Acronym
NBF15
Status last verified
Jul 2011
First submitted
29 Jul 2011
Last updated
2 Aug 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12377086

  • 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.

    PubMed 11068970

  • 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.

    PubMed 26692236

  • 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.

    PubMed 26465217

  • 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.

    PubMed 25382415

  • 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.

    PubMed 25367835

  • 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.

    PubMed 24484456

  • 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.

    PubMed 23750466

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing New Beginnings Program in people with Mental Disorder and Substance Use, run by Arizona State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnosis of mental health disorder (time frame: 15 year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01407120, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2011.

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