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Clinical Trials/NCT00319241
NCT00319241
Completed
Phase 2

Relational Parenting Group for Opioid-addicted Mothers

Yale University1 site in 1 country120 target enrollmentJanuary 1998

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Substance Abuse
Sponsor
Yale University
Enrollment
120
Locations
1
Primary Endpoint
Mother's psychosocial adjustment
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 1998
End Date
November 2003
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • suicidality/homicidality requiring more intensive level of care
  • serious cognitive impairment (AIDS-related dementia or schizophrenia)

Outcomes

Primary Outcomes

Mother's psychosocial adjustment

Mother's risk for maltreating her child

Mother's affective and instrumental parenting

Secondary Outcomes

  • Children's psychosocial adjustment
  • Mother's substance abuse

Study Sites (1)

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