Clinical Trials Logo

Clinical Trial Summary

This study is a randomized trial of interventions to improve parent-child relationships of drug-dependent mothers.


Clinical Trial Description

In this Stage II study, we will conduct a randomized clinical trial of the Relational Parenting Mothers' Group (RPMG), an intervention designed for opioid abusing mothers with children between the ages of 7 and 14 which was manualized and tested as part of a Stage I study (NIDA # P50-DA09241; September 1, 1994- August 31, 1997). This intervention was developed in recognition of the substantial psychosocial risks faced by substance abusing mothers and their offspring, and the notable lack of parenting interventions currently available for addicted mothers with children past the preschool years. Based on developmental psychopathology perspectives on resilience, this integrative treatment addresses multiple levels of adversity (individual, family, and community) faced by addicted mothers: risks that typically result in negative parenting behaviors and psychosocial distress among the mothers and concomitantly, psychiatric disturbance among their offspring. Designed as a supplement to standard drug counseling, RPMG is a structured and time-limited treatment, entailing 24 weekly group sessions of 1½ hours each.

Preliminary data collected in the Stage I pilot study have attested to the promise of RPMG in terms of diverse parenting behaviors and psychiatric outcomes among both mothers and their children. In the proposed study, we will conduct a randomized clinical trial in which mothers receiving RPMG as a supplement to Recovery Training (RT, a manualized group intervention representing standard drug counseling offered in methadone clinics) will be compared with those who receive RT alone. The RPMG clinical team will include one masters/doctoral level therapist and one assistant therapist and RT groups will be conducted by drug counselors; all therapists (RPMG & RT) will be trained and supervised by our research team. One hundred sixty mothers will be randomized to one of the two treatment conditions. Multiple-method, multiple-informant assessments will be used to measure salient outcomes; these will include reports from mothers and their children, and from the mothers' clinicians and their children's teachers.

We will address the following specific aims in this study:

1. We will evaluate the effectiveness of the Relational Parenting Mother's Group (RPMG) as a supplement to Recovery Training (RT) vs. Recovery Training alone in terms of a) mothers' parenting behaviors, b) their psychosocial adjustment, c) their children's psychosocial adjustment, and d) mothers' treatment compliance.

2. We will evaluate the comparative durability of RPMG+RT vs. RT in terms of the outcomes in Aim #1, and in terms of delayed improvement in frequency of illicit drug use, HIV-risk behaviors, and other problems related to drug use.

3. We will examine how specific maternal characteristics interact with treatment to affect outcomes. Guided by previous research, these characteristics will include mothers' intelligence, readiness for change, and sensation seeking. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00319241
Study type Interventional
Source Yale University
Contact
Status Completed
Phase Phase 2
Start date January 1998
Completion date November 2003

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04070521 - EEG Monitoring in the Emergency Department
Completed NCT00729391 - Women-Focused HIV Prevention in the Western Cape Phase 2/Phase 3
Active, not recruiting NCT03129334 - Preventing Prescription Drug Abuse in Middle School Students N/A
Completed NCT02733003 - Implementation Research for Vulnerable Women in South Africa N/A
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Completed NCT02573948 - Feasibility of Interventions on People Who Inject Drugs in Vietnam
Withdrawn NCT01847300 - cSBI-M for Young Military Personnel N/A
Withdrawn NCT01523444 - Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings Phase 3
Completed NCT01481428 - Reducing High Risk Behavior in Treatment Court Phase 1
Completed NCT01591239 - Home-Based Program to Help Parents of Drug Abusing Adolescents N/A
Completed NCT01601743 - Exercise as a Behavioral Treatment for Cocaine Dependence N/A
Active, not recruiting NCT00847548 - Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting N/A
Withdrawn NCT01228890 - Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT) Phase 3
Completed NCT01614015 - Building Outcomes With Observation-Based Supervision: An FFT Effectiveness Trial Phase 2
Completed NCT01621334 - The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use Phase 1
Completed NCT00841711 - Transitions: Linkages From Jail To Community N/A
Completed NCT00717444 - Healthy Activities for Prize Incentives N/A
Completed NCT00685074 - Computer-based Brief Intervention for Perinatal Substance Abuse Phase 1/Phase 2
Completed NCT01188434 - Integrating Interventions for Maternal Substance Abuse Phase 1
Completed NCT01465490 - Monitoring and Feedback in Substance Abuse Treatment Phase 1/Phase 2