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Clinical Trials/NCT01240993
NCT01240993
Completed
N/A

Fostering Mothers' Emotionally-Responsive Parenting

Yale University2 sites in 1 country100 target enrollmentJuly 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parenting Capacities of Substance Abusing Mothers
Sponsor
Yale University
Enrollment
100
Locations
2
Primary Endpoint
Parent Development Interview coded for maternal reflective functioning
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

A formal randomized efficacy trial testing the Mothers and Toddlers' program, an attachment-based parenting intervention for mothers enrolled in addiction treatment and caring for young children.

Detailed Description

Five years ago the investigators were funded to develop the Mothers and Toddlers Program (MTP; R01 DA17294 / Project Period: 8/20/04 - 12/31/09). MTP is the first parenting intervention developed for substance abusing mothers based on the attachment theory. It is also the only parenting intervention for substance abusing mothers that has led to improvement in maternal caregiving sensitivity and responsiveness to infant and toddler distress in observed lab-based interactions. The investigators now have all the research materials to conduct a Stage II randomized clinical trial including a treatment manual, treatment fidelity scales therapist training program and outcome measures. In this Stage II formal efficacy trial, the investigators (1) Introduce new measures of dyadic adjustment and child attachment, (2) Add an 18 week follow up period to test for sustained treatment effects, (3) Measure major constructs (reflective functioning, representations, dyadic adjustment, and child attachment) when they are expected to change, (4) Examine temporal mechanisms of change proposed in the MTP treatment model (5) Determine whether improvements in dyadic adjustment reduces incidence of relapse, (6) Broaden the MTP therapist pool by training four new therapists and (7) Broaden the coding pool by training 3 additional coders per measure. One hundred and fifty mothers caring for children ages 12 to 60 months of age will be recruited from outpatient substance abuse treatment services at the APT Foundation into the intention-to-treat sample and will be randomized to 12 weeks of MTP vs. PEP and followed for 33 weeks.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
September 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All mothers ages 21 to 45 years, who are enrolled in treatment at one of the five APT Foundation clinics and caring for a biological child between 12 and 60 months of age will be eligible to participate.

Exclusion Criteria

  • Severe mental health problems (e.g., suicidal, homicidal, psychosis, thought disorder)
  • Severe cognitive impairment
  • Inability to speak English
  • Target child with serious illness or significant developmental delay (e.g., cognitive, language, or motor).

Outcomes

Primary Outcomes

Parent Development Interview coded for maternal reflective functioning

Time Frame: Change at week 33 (follow up) from baseline

The Parent Development Interview (PDI; Slade, Aber, Berger, Bresgi, \& Kaplan, 2002) 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.

Secondary Outcomes

  • Working Model of the Child Interview (coded for representation quality)(Change at week 33 (follow up) from baseline)
  • NCAST Teaching Scales (Maternal Behavior)(Change at week 33 (follow up) from baseline)
  • Brief Symptom Inventory(Change at week 33 (follow up) from baseline)
  • Curiosity Box Paradigm(Change at week 33 (follow up) from baseline)
  • Beck Depression Inventory(Change at week 33 (follow up) from baseline)
  • NCAST Teaching Scales (Child Behavior)(Change at week 33 (follow up) from baseline)
  • Child Attachment Status(Change at week 12 (post-treatment) from baseline)

Study Sites (2)

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