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Clinical Trials/NCT00319436
NCT00319436
Completed
Not Applicable

Fostering Mothers' Emotionally Responsive Parenting

Yale University1 site in 1 country47 target enrollmentAugust 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maternal Substance Use
Sponsor
Yale University
Enrollment
47
Locations
1
Primary Endpoint
Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
August 2004
End Date
March 2009
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)

Time Frame: post-treatment and 6-week follow up

The Parent Development Interview (PDI) was used to measure maternal capacity to mentalize about her own and her child's behavior. The PDI is a 1 hour semi-structured interview designed to elicit the mother's narrative about commonly occurring, emotionally-challenging aspects of parenting. A rating of 1 indicates a absence of recognition of mental states. A rating of 3 indicates a limited capacity to acknowledge mental states. A rating of 5 indicates the presence of a rudimentary capacity for reflective functioning.

Quality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)

Time Frame: post-treatment, 6-week follow up

The Working Model of the Child Interview (WMCI; Zeanah \& Benoit, 1993) is a 1.5 hour interview used to elicit a narrative description of the mother's perceptions of her child and their relationship. The rater was trained to reliably code 6 qualitative subscales: Openness, Richness, Coherence, Caregiving Sensitivity and Acceptance and Involvement. On the mean of six subscales, a score of three is considered to represent average representational quality, scores of 1 and 2 are considered to represent clinical risk and scores of 4 and 5 are considered to represent optimal quality.

Secondary Outcomes

  • Maternal Depression (Measured With the Beck Depression Inventory)(post-treatment and 6-wk follow up)
  • Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)(post-treatment, 6-week follow up)
  • Maternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)(post-treatment and 6-wk follow up)
  • Maternal Substance Abuse (Assessed With Urine Toxicology Screens)(post-treatment and 6-wk follow up)
  • Child Behavior (Assessed With the NCAST Teaching Scales)(post-treatment and 6-wk follow up)

Study Sites (1)

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