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Fostering Mothers' Emotionally Responsive Parenting
This study is currently recruiting participants.
Verified by Yale University, June 2008
First Received: April 26, 2006   Last Updated: June 12, 2008   History of Changes
Sponsored by: Yale University
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00319436
  Purpose

The primary goal of this Stage I therapy development study will be to manualize and test the preliminary efficacy of a parenting intervention for drug dependent mothers that aims to foster their ability to recognize children's emotional needs at different ages and their capacity to be emotionally available to their children.


Condition Intervention Phase
Maternal Substance Use
Child Abuse
Behavioral: The Mothers and Toddlers Program
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Fostering Mothers' Emotionally Responsive Parenting

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Maternal capacity for reflective functioning [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Coherence of maternal narratives [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Maternal psychosocial adjustment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal sensitivity to children's emotional cues [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Children's use of the mother during exploration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Maternal substance abuse [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: August 2004
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: The Mothers and Toddlers Program
    The Mothers and Toddlers Program (MTP) is a 12 - 24 week individual therapy program for mothers enrolled in outpatient treatment for substance abuse who are caring for children between birth and three years of age. The goal of this clinical intervention is to facilitate shifts toward more balanced maternal representations of children and enhance maternal capacity for thinking reflectively about children's behavior (i.e., reflective functioning). We hypothesize that change at the representational level will correspond to change at the behavioral level (mother-child interactions).
Detailed Description:

Mothers who are physically and/or psychologically dependent upon alcohol and drugs are at risk for a wide range of parenting deficits beginning when their children are infants and continuing as their children move through school-age and adolescent years. Behavioral parent training programs for drug dependent mothers have had limited success in improving mother-child relationships or children's psychosocial adjustment. One reason behavioral parenting programs may have had limited success is the lack of attention to emotional aspects of the mother-child relationship, including (1) mothers' recognition of their children's emotional needs and (2) mothers' capacity to respond sensitively to their children's emotional cues. Research on attachment suggests that the emotional quality of the early mother-child relationship has important implications for many developmental capacities, including emotional and behavior regulation in early years, and social competence academic achievement in school-aged and adolescent years. In this Stage I therapy development study, we propose to modify a previously piloted attachment-based group parenting intervention called Emotionally-Responsive Parenting Group or ERP. The goal of the intervention is to improve the mother's capacity to recognize and sensitively respond to her child's emotional cues. In a pre-pilot study (see Preliminary Study 6) we tested the feasibility of conducting the ERP group intervention as an adjunct group treatment for 23 primarily cocaine-dependent mothers in outpatient drug treatment and found that ERP was highly feasible and showed initial promise for improving maternal recognition of emotional cues. In this study, we aim to modify and validate the intervention as an individual therapy for drug dependent mothers of children ages 18 to 36 months in preparation for a Stage II controlled efficacy trial.

More specifically, we will:

  1. Develop and modify a 12-session ERP individual therapy for drug dependent mothers enrolled in outpatient drug treatment have custody of a child between 18 and 36 months of age. Fifteen mothers enrolled in outpatient drug treatment will participate in this phase of the ERP manual's development.
  2. Develop and implement a therapist training and supervision program for delivery of the ERP manualized treatment. This phase will include the development of ERP adherence and competence rating scales.
  3. Conduct a randomized, controlled pilot study to determine the potential feasibility, acceptability, and efficacy of ERP compared with, Parent Education (PE), a 12-week comparison condition in which mothers will attend 12 1-hour parent education sessions conducted by a paraprofessional. Sixty mothers enrolled in outpatient drug treatment who have at least one child between the ages of 18 and 36 months in their custody will participate.

    Because the intervention will directly target change in maternal psychological representations of parenting, primary outcomes will be (a) maternal 'reflective functioning' (capacity to make inferences about emotional cues, (b) capacity for balanced psychological representations of the child, and (c) knowledge of the child's developmental capacities. The intervention will indirectly target maternal and child behavior and maternal psychosocial adjustment. Secondary outcomes will be: maternal sensitivity to her child's emotional cues, the child's use of the mother as a secure base, and maternal psychiatric distress, daily functioning and substance abuse.

  4. Explore the impact of process variables on outcomes, and potential mediator and moderator effects.. Process variables will be: (a) attendance, (b) therapeutic alliance, (c) therapist adherence and competence and (d) use of additional treatment services.
  Eligibility

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

Inclusion Criteria:

  • English-speaking adult women
  • history of primary alcohol, cocaine, cannabis, club drug, or heroin abuse or dependence
  • caring for a child between 1 and 36 months of age

Exclusion criteria:

  • acute suicidality/ homicidality
  • severe psychiatric or substance-related symptoms requiring in-patient hospitalization or ambulatory detoxification
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319436

Contacts
Contact: Nicole Castiglioni, B.A. 203-781-4646 ext 143 nicole.castiglioni@yale.edu
Contact: Cindy Decoste, M.S. 203-781-4646 ext 146 cindy.decoste@yale.edu

Locations
United States, Connecticut
The APT Foundation Recruiting
New Haven, Connecticut, United States, 06519
Principal Investigator: Nancy E Suchman, Ph.D.            
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Nancy E Suchman, Ph.D. Yale University
  More Information

Publications:
Suchman N, Mayes L, Conti J, Slade A, Rounsaville B. Rethinking parenting interventions for drug-dependent mothers: from behavior management to fostering emotional bonds. J Subst Abuse Treat. 2004 Oct;27(3):179-85.
Suchman N, Pajulo M, Decoste C, Mayes L. Parenting Interventions for Drug-Dependent Mothers and Their Young Children: The Case for an Attachment-Based Approach. Fam Relat. 2006 Apr;55(2):211-226.
Suchman, N., DeCoste, & Mayes, L. (in press). The Mothers and Toddlers Program: An attachment-based intervention for mothers in substance abuse treatment. Invited chapter to be published in C. Zeanah (Ed.), Handbook of infant mental health, 3rd edition. New York, NY: Guilford Press.

Responsible Party: Yale School of Medicine Grants and Contracts ( Rita Nigri, Associate Director, Grants and Contracts )
Study ID Numbers: R01 DA017294, R01 DA17294
Study First Received: April 26, 2006
Last Updated: June 12, 2008
ClinicalTrials.gov Identifier: NCT00319436     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Yale University:
parenting intervention
family intervention
maternal substance abuse
mother-child relations
parent-child relations

ClinicalTrials.gov processed this record on August 30, 2009