Clinical trial NCT06132971: Multi-court Trial of NBP to Prevent Substance Abuse and Mental Health Disorders (MTC)
Official title: Multi-court Trial of NBP to Prevent Substance Abuse and Mental Health Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Divorce
Drug Abuse
Mental Health Disorder
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-11-15
Enrollment: 2415
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Child Behavior Checklist Internalizing Problems
timeFrame: The time frame was the past month
measure: Brief Problem Monitor Internalizing
timeFrame: Time Frame was the past month
measure: Child Behavior Checklist Externalizing Problems
timeFrame: The timeframe was the past month
measure: Parent report of total child behavior problems
timeFrame: The time frame was the past month
measure: Brief Problem Monitor Externalizing
timeFrame: The time frame is past month
measure: Brief Problem Monitor Total Problems
timeFrame: The time frame is past month
measure: Preschool Child Behavior Checklist Internalizing Problems
timeFrame: Past month
measure: Parent report of child internalizing problems
timeFrame: Past month
measure: Parent report of child externalizing problems
timeFrame: Past month
measure: Parent report of child externalizing problems
timeFrame: Past month
Secondary outcomes:
measure: Parent Report of Parent child relationship quality
timeFrame: Time frame was the past month
measure: Parent Report of Rejection
timeFrame: Time frame was the past month
measure: Monitoring
timeFrame: Time frame was the past month
measure: Parent report of Discipline
timeFrame: Time frame was the past month
measure: Child report of positive parenting
timeFrame: Time Frame was the past month
Other outcomes:
measure: Parent report of Interparental conflict
timeFrame: Past month
measure: Child report of exposure to interparental conflict
timeFrame: Past month
measure: Child report of being caught in the middle
timeFrame: Past month
Locations:
city: Tempe
country: United States
facility: Sharlene Wolchik
state: Arizona
Study officials:
References: