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Relational Parenting Group for Opioid-addicted Mothers

Primary Purpose

Substance Abuse, Child Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Parenting Intervention
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring parenting intervention, substance abuse treatment, mother-child relations, parent-child relations, child abuse and neglect

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • The APT Foundation

Outcomes

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

Full Information

First Posted
April 26, 2006
Last Updated
March 27, 2020
Sponsor
Yale University
Collaborators
APT Foundation, Inc., National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00319241
Brief Title
Relational Parenting Group for Opioid-addicted Mothers
Official Title
Relational Parenting Group for Opioid-addicted Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
November 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
APT Foundation, Inc., National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Child Abuse
Keywords
parenting intervention, substance abuse treatment, mother-child relations, parent-child relations, child abuse and neglect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Parenting Intervention
Primary Outcome Measure Information:
Title
Mother's risk for maltreating her child
Title
Mother's affective and instrumental parenting
Title
Mother's psychosocial adjustment
Secondary Outcome Measure Information:
Title
Children's psychosocial adjustment
Title
Mother's substance abuse

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suniya Luthar, Ph.D.
Organizational Affiliation
Teachers College, Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Suchman, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
The APT Foundation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17241493
Citation
Luthar SS, Suchman NE, Altomare M. Relational Psychotherapy Mothers' Group: a randomized clinical trial for substance abusing mothers. Dev Psychopathol. 2007 Winter;19(1):243-61. doi: 10.1017/S0954579407070137.
Results Reference
result

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Relational Parenting Group for Opioid-addicted Mothers

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