Relational Parenting Group for Opioid-Addicted Mothers

This study has been completed.
Sponsor:
Collaborator:
APT Foundation, Inc.
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00319241
First received: April 26, 2006
Last updated: June 16, 2008
Last verified: June 2008
  Purpose

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


Condition Intervention Phase
Substance Abuse
Child Abuse
Behavioral: Parenting Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relational Parenting Group for Opioid-Addicted Mothers

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Mother's risk for maltreating her child
  • Mother's affective and instrumental parenting
  • Mother's psychosocial adjustment

Secondary Outcome Measures:
  • Children's psychosocial adjustment
  • Mother's substance abuse

Estimated Enrollment: 120
Study Start Date: January 1998
Study Completion Date: November 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • female adult humans
  • enrollment in methadone treatment for opioid addiction
  • caring for a child between the ages of 7 and 14 years

Exclusion Criteria:

  • suicidality/homicidality requiring more intensive level of care
  • serious cognitive impairment (AIDS-related dementia or schizophrenia)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319241

Locations
United States, Connecticut
The APT Foundation
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
APT Foundation, Inc.
Investigators
Principal Investigator: Suniya Luthar, Ph.D. Teachers College, Columbia University
Study Director: Nancy Suchman, Ph.D. Yale University
  More Information

Publications:
Responsible Party: Nancy E Suchman, PhD, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00319241     History of Changes
Other Study ID Numbers: R01 DA11498
Study First Received: April 26, 2006
Last Updated: June 16, 2008
Health Authority: United States: Federal Government

Keywords provided by Yale University:
parenting intervention
substance abuse treatment
mother-child relations
parent-child relations
child abuse and neglect

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014