Relational Parenting Group for Opioid-Addicted Mothers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00319241
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : June 18, 2008
APT Foundation, Inc.
Information provided by:
Yale University

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

Condition or disease Intervention/treatment Phase
Substance Abuse Child Abuse Behavioral: Parenting Intervention Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relational Parenting Group for Opioid-Addicted Mothers
Study Start Date : January 1998
Actual Primary Completion Date : October 2003
Actual Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting
U.S. FDA Resources

Primary Outcome Measures :
  1. Mother's risk for maltreating her child
  2. Mother's affective and instrumental parenting
  3. Mother's psychosocial adjustment

Secondary Outcome Measures :
  1. Children's psychosocial adjustment
  2. Mother's substance abuse

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00319241

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

Publications of Results:
Responsible Party: Nancy E Suchman, PhD, Yale University School of Medicine Identifier: NCT00319241     History of Changes
Other Study ID Numbers: R01DA011498 ( U.S. NIH Grant/Contract )
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: June 18, 2008
Last Verified: June 2008

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