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

NCT06132971 | Completed DMC

• 1 other identifier: R01 DAO26874-01A1
• Study Type: interventional
• Target: 2,415
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Divorce; Drug Abuse; Mental Health Disorder

Outcome Measures

Primary Outcomes (10)

• 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.

  The time frame was the past month

• 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),

  Time Frame was the past month

• 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)

  The timeframe was the past month

• 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).

  The time frame was the past month

• 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).

  The time frame is past month

• 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).

  The time frame is past month

• 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)

  Past month

• 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).

  Past month

• 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).

  Past month

• 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).

  Past month

Secondary Outcomes (5)

• Parent Report of Parent child relationship quality

  Time frame was the past month

• Parent Report of Rejection

  Time frame was the past month

• Monitoring

  Time frame was the past month

• Parent report of Discipline

  Time frame was the past month

• Child report of positive parenting

  Time Frame was the past month

Other Outcomes (3)

• Parent report of Interparental conflict

  Past month

• Child report of exposure to interparental conflict

  Past month

• Child report of being caught in the middle

  Past month

Study Arms (2)

NBP2

ACTIVE COMPARATOR

Participants were assigned to the 2-session New Beginnings Program intervention

Behavioral: New Beginnings Program

NBP10

EXPERIMENTAL

Participants were assigned to the 10-session New Beginnings Program

Behavioral: New Beginnings Program

Interventions

New Beginnings Program BEHAVIORAL

NBP10; NBP2

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Sharlene Wolchik

Tempe, Arizona, 85287, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All data was collected by trained interviewers or teachers. All data collectors were masked as to study conditions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: November 15, 2023
• Study Start: July 30, 2012
• Primary Completion: August 4, 2015
• Study Completion: January 31, 2017
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

US (1)