Trial of Mentalization-Based Therapy for Substance Using Mothers of Infants and Toddlers

Yale University

Status: Completed

Conditions: Parenting Capacities of Substance Abusing Mothers

Treatments: Behavioral: Mothers and Toddlers Program; Behavioral: Parent Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01240993

0407026890-C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Parent Education

Active Comparator group

Description:

PE was developed to represent parent education and support that is typically available to mothers with substance use problems who are at high risk for neglecting their young children. Mothers enrolled in PEP will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will also provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed specifically for this study.

Treatment:

Behavioral: Parent Education

Mothers and Toddlers Program

Experimental group

Description:

This intervention is an introductory, short-term, supportive, psychodynamic therapy for substance using mothers of young children that emphasizes the development of the capacity for mentalizing. Mothers meet with an individual, MBT-trained psychodynamically-oriented therapist for 12 sessions. The intervention is conducted a clinic where mothers are enrolled in treatment for their substance abuse.

Treatment:

Behavioral: Mothers and Toddlers Program