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DivorceMTCNCT06132971

Multi-court Trial of NBP to Prevent Substance Abuse and Mental Health Disorders (MTC)

A study testing New Beginnings Program in people with Divorce and Drug Abuse, 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

This application requests funding to conduct a randomized effectiveness trial of The New Beginnings Program (NBP) delivered through a partnership of domestic relations courts, community service providers and the NBP research team. Read more about this study

Who is it for?
Ages 3 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Divorce, Drug Abuse, Mental Health Disorder
What is being tested?
New Beginnings Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,415 participants
Where
1 siteUnited States
Study dates
30 Jul 2012to 31 Jan 2017
Phase
Interventional
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 3 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Filing for divorce or modification of a divorce decree within the past two years
  • If never married, being in court to establish or change a parenting time agreement following separation in the past two years
  • Having at least one child aged 3 to 18 with whom the parent spends three or more hours each week or one overnight every other week
  • Being able to complete the program and assessments in English
  • Not being mandated to a parenting class by the Juvenile Court or Child Protective Services.

Who cannot join

  • Parents who received a divorce more than two years prior and did not have any court involvement in the past two years.
  • Parents who could not complete the program or assessments in English
  • Parents were mandated to a parenting program by Child Protective Services of Juvenile Court

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Sharlene Wolchik

    Tempe, Arizona, 85287

Other trials in United States

About this study

Official title: Multi-court Trial of NBP to Prevent Substance Abuse and Mental Health Disorders

This application requests funding to conduct a randomized effectiveness trial of The New Beginnings Program (NBP) delivered through a partnership of domestic relations courts, community service providers and the NBP research team. This is the first attempt to offer the population of families seeking divorce an evidence-based prevention program shown to have long-term effects on youth problem outcomes. It is estimated that over a third of U.S. children experience parental divorce, which confers elevated risk for multiple problems in childhood and adulthood including substance use and abuse, smoking, mental health problems, high risk sexual behavior, and physical health problems. Efficacy trials of the NBP found positive effects at post-test, 6-year and 15-year follow-ups. For example, at 6-year follow-up the participation in NBP led to reductions in marijuana, drug and alcohol use and a 37% reduction in prevalence of diagnosed mental disorder; and reductions in externalizing problems, internalizing problems and high risk sexual behavior. Positive effects also occurred for grade point average (GPA) and self esteem. For many of the effects of the NBP, the effects were stronger for youth who were at higher risk at program entry. Many of the program effects were mediated through the program effects to strengthen parenting. Funded by an Advanced Center for Intervention and Services Research grant (NIMH P30 MH068685) the investigators modified the NBP to translate it from a prototype tested in efficacy trials into a program that can be effectively delivered by community service providers and one that is appropriate across diverse cultural groups, and fathers as well as mothers. Pilot testing of the modified NBP and training and monitoring systems has demonstrated that they are highly acceptable to parents and providers. The investigators also developed and experimentally tested a system of parent recruitment that was found to be effective in getting parents to enroll (sign up to participate) in the NBP but, similar to other prevention parenting programs, initiation (attendance at one or more sessions) in the NBP in the pilot was low.

Read the detailed description

SPECIFIC AIMS This application requests funding to conduct a randomized effectiveness trial of The New Beginnings Program (NBP), a prevention program for divorced families, as delivered through a partnership of domestic relations courts, community service providers and the NBP research team. This partnership would be the first systematic attempt to offer the population of families seeking divorce an evidence-based prevention program shown to have long-term effects to reduce youth problem outcomes. It is estimated that over a third of U.S. children experience parental divorce which confers elevated risk for multiple problems in childhood, adolescence and adulthood including substance use and abuse, cigarette smoking, mental health problems, high risk sexual behavior, and physical health problems. When evaluated in efficacy trials, the NBP has been shown to have positive program effects at post-test, 6-year and 15-year follow-ups. For example, at 6-year follow-up the participation in NBP led to reductions in marijuana, drug and alcohol use; a 37% reduction in prevalence of diagnosed mental disorder; and reductions in externalizing problems, internalizing problems and high risk sexual behavior. Positive program effects also occurred for grade point average (GPA) and self esteem. For many of the short- and long-term effects of the NBP, the effects were stronger for youth who were at higher risk at program entry. Mediational analyses have shown that program effects on short-term and 6-year youth outcomes were mediated through the program effects to strengthen parenting. Funded by an Advanced Center for Intervention and Services Research grant (NIMH P30 MH068685) the investigators modified the NBP to translate it from a prototype tested in efficacy trials into a program that can be effectively delivered by community service providers and one that is appropriate for diverse cultural groups, a broad age range of youth, and fathers as well as mothers. The investigators also revised the methods for training, technical assistance and ongoing monitoring of implementation. Pilot testing of the modified NBP and training and monitoring systems has demonstrated that they are highly acceptable to parents and providers. The investigators also developed and experimentally tested a system of parent recruitment that builds on an infrastructure that exists in domestic relations courts in 46 states. This strategy was effective in getting parents to enroll (sign up to participate) in the NBP but, similar to other prevention parenting programs, initiation (attendance at one or more sessions) in the NBP in the pilot was low.

The Specific Aims are to:

  1. Examine whether 1380 children in 920 divorcing families randomly assigned to the NBP or workshop controls, show greater improvement when assigned to the NBP on measures of positive parenting, youth substance use and mental health problems compared to controls. Assessments will occur at pre-test, post-test and 6-month follow-up. The study will also test whether program effects on youth outcomes at the 6-month follow-up are mediated by program-induced effects on positive parenting at post-test. This will be the first experimental evaluation of the effectiveness of an evidence-based parenting program to prevent substance use and mental health problems of youth from divorcing families when delivered through a partnership of the courts and community service providers.
  2. Test whether the effects of the NBP are moderated by level of child risk at program entry, youth age, parent gender or parent's ethnicity [i.e., Mexican American (MA) vs. non-Hispanic Caucasians (NHW)]. Based on previous trials of the NBP, a significant program x baseline risk interaction is predicted with stronger program effects expected at higher levels of child risk. Because the program was modified and pilot tested to make it appropriate across ethnic groups, parent gender, and age of child, testing the interaction effect for these three variables is viewed as exploratory and no significant interactions are predicted.
  3. Examine whether variability in implementation accounts for variability in parenting and youth outcomes. Multiple dimensions of implementation that have been found to relate to outcomes of prevention parenting programs will be measured (e.g., fidelity, group leader process quality, additive adaptation, participant responsiveness) and their unique contribution to program effects will be assessed. The investigators will also test whether gender or ethnicity moderate the relations between each dimension of implementation and outcomes.
  4. Experimentally test whether a brief telephone engagement interview increases initiation (i.e. attending at least one session) relative to a standard informational contact. The effect of the engagement interview will be tested for the overall sample, and separately for males and females, and MA and NHW.

The results of this study have significant public health implications to reduce substance abuse and mental health problems of youth who experience parental divorce, a highly prevalent stressful event. Further, the proposed study addresses three issues that have substantial implications for the effectiveness of parent-focused preventive interventions: subgroup differences in program benefits, relations of dimensions of implementation to outcomes and engagement of parents in evidence-based parenting programs.

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

What participants receive

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

  • New Beginnings ProgramBehavioural

Study groups in NCT06132971
Study groupRoleWhat they receive
NBP2Active comparatorParticipants were assigned to the 2-session New Beginnings Program intervention
Receives: Behavioral: New Beginnings Program
NBP10ExperimentalParticipants were assigned to the 10-session New Beginnings Program
Receives: Behavioral: New Beginnings Program

What is being measured

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

  1. Child Behavior Checklist Internalizing Problems

    Parents completed the Child Behavior Checklist which has previously shown good reliability and validity (CBCL; Achenbach \& Rescorla, 2001) for children aged 6 to 18 (α = .89 ) for internalizing, problems.

    Measured: The time frame was the past month

  2. Brief Problem Monitor Internalizing

    Children aged 9 or older completed the Brief Problem Monitor (BPM; Achenbach, McConaughy, Ivanova, \& Rescorla, 2011) to assess internalizing (six items, α = .79),

    Measured: Time Frame was the past month

  3. Child Behavior Checklist Externalizing Problems

    Parents completed the Child Behavior Checklist which has previously shown good reliability and validity (CBCL; Achenbach \& Rescorla, 2001) for children aged 6 to 18 (α =.90, and .95 for externalizing problems)

    Measured: The timeframe was the past month

  4. Parent report of total child behavior problems

    A single measure of parent total behavior problems was calculated as the sum of the T scores across parent report of total behavior problems from the CBCL and Pre-school CBCL across the broad age range (T. M. Achenbach, personal communication, 2015).

    Measured: The time frame was the past month

  5. Brief Problem Monitor Externalizing

    Children aged 9 or older completed the Brief Problem Monitor (BPM; Achenbach, McConaughy, Ivanova, \& Rescorla, 2011) to assess externalizing (seven items, α = .71).

    Measured: The time frame is past month

  6. Brief Problem Monitor Total Problems

    Children aged 9 or older completed the Brief Problem Monitor (BPM; Achenbach, McConaughy, Ivanova, \& Rescorla, 2011) to assess total problems (19 items, α = .86).

    Measured: The time frame is past month

  7. Preschool Child Behavior Checklist Internalizing Problems

    Parents completed the Preschool Child Behavior Checklist (Pre-CBCL; Achenbach \& Rescorla, 2000) for children aged 3 to 5 (α = .89) for internalizing problems)

    Measured: Past month

  8. Parent report of child internalizing problems

    T scores were calculated for CBCL and Pre-CBCL internalizing problem subscales based on child age and gender and combined to assess internalizing across the broad age range (T. M. Achenbach, personal communication, 2015).

    Measured: Past month

  9. Parent report of child externalizing problems

    Parents completed the Preschool Child Behavior Checklist (Pre-CBCL; Achenbach \& Rescorla, 2000) for children aged 3 to 5 (α = .91 for externalizing problems).

    Measured: Past month

  10. Parent report of child externalizing problems

    Parent report of child externalizing problems was scored as the sum of T scores for the CBCL and Pre-CBCL externalizing subscales based on child age and gender and combined to assess internalizing, externalizing, and total problems across the broad age range (T. M. Achenbach, personal communication, 2015).

    Measured: Past month

Secondary outcomes (5)
  1. Parent Report of Parent child relationship quality

    Parent-child relationship quality was assessed using factor scores from a two-factor confirmatory factor analysis model. Indicators of parent-child relationship quality were involvement (six items, Menning, 2006), family routines (seven items, Jensen, et al., 1983), parent-child communication (10 items open communication subscale, Barnes and Olsen, 1982), closeness (single item, Stewart, 2003) and acceptance subscale of the CRPBI (16 items, Shaefer, 1965). The two-factor model closely fit the data at pretest, χ2 (17) = 69.8.

    Measured: Time frame was the past month

  2. Parent Report of Rejection

    We treated parent report of rejection as a separate measure because it did not load highly with the other indicators of parent-child relationship. Parent report of rejection was assessed using the rejection subscale of the CRPBI (16 items, Schaefer, 1965)

    Measured: Time frame was the past month

  3. Monitoring

    Parent report of monitoring as a separate measure because parents completed this measure only for children age 9 or older. Monitoring was assessed using the Child Monitoring Scale (11 items, Hetherington et al., 1992).

    Measured: Time frame was the past month

  4. Parent report of Discipline

    Parent report of discipline was assessed as a single measure which aggregated the scores from multiple indicators using factor scores from a two-factor confirmatory factor analysis model. The two-factor model closely fit the data at pretest, χ2 (17) = 69.8.

    Indicators of discipline that loaded on the discipline factor were consistency subscale of the CRPBI (16 items Schaefer, 1965), follow-through subscale of the Oregon Discipline Scale (11 items, Oregon Social Learning Center, 1991), and appropriate use of discipline (ratio) from the Oregon Discipline Scale (14 items. Oregon Social Learning Center).

    Measured: Time frame was the past month

  5. Child report of positive parenting

    Child report of positive parenting was assessed as a single factor score which aggregated the scores from multiple indicators as the factor score based on a a confirmatory factor analysis which found that a single factor model had a good fit to the data χ2 (17) = 58.25, RMSEA = .07. CFI = .98. The indicators on this model were child reports of involvement (six items, Menning, 2006), family routines (7 items, Jensen et al., 1983), open communication subscale of the Parent-Adolescent Communication Scale (10 items, Barnes a\\& Olson, 1982), closeness was measured using a single item (Stewart, 2003), the acceptance subscale of the CRPBI (16 items, Schaefer, 1965), the rejection subscale of the CRPBI (16 items, Schaefer, 1965), the consistency of discipline subscale of the CRPBI (8 items, Schaefer, 1965), and the Child Monitoring Scale (11 items, Hetherington et al., 1992).

    Measured: Time Frame was the past month

Timeline

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

  1. First posted15 Nov 2023
  2. Study start30 Jul 2012
  3. Primary completion4 Aug 2015
  4. Study completion31 Jan 2017

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06132971
Sponsor's protocol ID
R01 DAO26874-01A1
Acronym
MTC
Status last verified
Nov 2023
First submitted
10 Jul 2018
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing New Beginnings Program in people with Divorce and Drug Abuse, 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 5 inclusion and 3 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 15 Nov 2023. 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.

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?

Child Behavior Checklist Internalizing Problems (time frame: The time frame was the past month). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Nov 2023.

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