Stage III Community-based Efficacy Trial for Mothering From the Inside Out



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:1/17/2019
Start Date:April 2015
End Date:January 2020
Contact:Nancy Suchman, Ph.D.
Email:nancy.suchman@yale.edu
Phone:203-285-1472

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Fostering Mothers' Emotionally-Responsive Parenting: A Stage III Community-Based Efficacy Trial

This is a Stage III community-based randomized clinical efficacy trial testing Mothering from
the Inside Out (MIO), the first evidence-based parenting intervention designed to be
delivered by addiction counselors in addiction treatment settings where parents of young
children are enrolled in treatment.

This is a new Stage III community-based randomized clinical efficacy trial testing Mothering
from the Inside Out (MIO), the first evidence-based parenting intervention designed to be
delivered by addiction counselors in addiction treatment settings where parents of young
children are enrolled in treatment. MIO is a weekly individual parenting therapy developed as
an enhancement to standard addiction treatment that targets the addicted mother's capacity to
recognize and regulate her own emotional distress during stressful parenting situations so
that she can support her child's developing capacity for emotional and behavioral regulation.
This capacity, called reflective functioning (RF), is a psychological skill that promotes
abstinence and also helps parents foster their young children's secure attachment. Now that
MIO has demonstrated efficacy in two randomized efficacy trials, the next step will be to
conduct a new Stage III community-based efficacy trial where addiction counselors are trained
to deliver MIO and PE with fidelity in an addiction treatment setting and to evaluate
treatment outcomes and mechanisms of change in this community setting. At the end of this
trial, if MIO demonstrates efficacy, all the necessary materials will be ready to train
addiction counselors across a broad range of treatment settings in a Stage IV effectiveness
trial. 120 mothers in addiction treatment and caring for children ages 11 - 60 months will be
randomized to 12 sessions of MIO vs PE with a trained addiction counselor and fidelity will
be monitored and maintained for treatment duration. It is expected that MIO-assigned mothers
will demonstrate greater improvement in the primary targeted outcome - reflective functioning
at week 12 (end of treatment) and week 33 (end of follow up). It is also predicted that
MIO-assigned mothers will demonstrate greater improvement in secondary outcomes, including
maternal sensitivity, caregiving behavior, psychiatric distress, depression and substance use
at week 12 (end of treatment) and week 33 (end of follow up). Finally, it is predicted that
children of MIO-assigned mothers will demonstrate greater improvement in the secondary
outcome - attachment security - at week 12 (end of treatment) and week 33 (end of follow up).

Inclusion Criteria:

- English-speaking female adults (18-65 years of age)

- Receiving outpatient substance abuse treatment services at the APT Foundation

- Caring for at least one child between 11 and 60 months of age

- Express interest in receiving assistance with parenting

Exclusion Criteria:

- Actively suicidal, homicidal, or severe cognitive impairment
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