Fostering Mothers' Emotionally Responsive Parenting
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Fostering Mothers' Emotionally Responsive Parenting |
- 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 ]
- 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) |
-
Behavioral: The Mothers and Toddlers Program
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:
- 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.
- 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.
- 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.
- 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 |
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| 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 |
| United States, Connecticut | |
| The APT Foundation | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Principal Investigator: Nancy E Suchman, Ph.D. | |
| Principal Investigator: | Nancy E Suchman, Ph.D. | Yale University |
More Information
Publications:
| Responsible Party: | Rita Nigri, Associate Director, Grants and Contracts, Yale School of Medicine Grants and Contracts |
| ClinicalTrials.gov Identifier: | NCT00319436 History of Changes |
| Other Study ID Numbers: | R01 DA017294, R01 DA17294 |
| Study First Received: | April 26, 2006 |
| Last Updated: | June 12, 2008 |
| 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 May 16, 2013