Clinical trial NCT02955199: Stage III Community-based Efficacy Trial for Mothering From the Inside Out
Official title: Fostering Mothers' Emotionally-Responsive Parenting: A Stage III Community-Based Efficacy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Addiction
Substance Abuse Drug Chronic
Child Neglect
Child Neglect Emotional
Child Abuse
Parenting
Parent-Child Problem
Parent-Child Relations
Parent / Child Problem
Parenteral Drug Abuse
Parents
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-11-04
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Maternal Reflective Functioning coded using the Parent Development Interview
timeFrame: Change from baseline in reflective functioning at 12 weeks
measure: Maternal Reflective Functioning coded using the Parent Development Interview
timeFrame: Change from baseline in reflective functioning at 33 weeks
Secondary outcomes:
measure: Maternal Sensitivity coded with Ruth Feldman's Coding Interactive Behavior (CIB) Scales
timeFrame: Change from baseline in maternal sensitivity at 12 weeks
measure: Maternal Sensitivity coded with Ruth Feldman's Coding Interactive Behavior (CIB) Scales
timeFrame: Change from baseline in maternal sensitivity at 33 weeks
measure: Maternal Caregiving Behavior coded with the Nursing Child Assessment Satellite Training (NCAST) Teaching Scales
timeFrame: Change from baseline in maternal caregiving behavior at 12 weeks
measure: Maternal Caregiving Behavior coded with the Nursing Child Assessment Satellite Training (NCAST) Teaching Scales
timeFrame: Change from baseline in maternal caregiving behavior at 33 weeks
measure: Child Attachment coded during the Strange Situation Paradigm (SSP)
timeFrame: Change from baseline in child attachment status at 12 weeks
measure: Child Attachment coded during the Strange Situation Paradigm (SSP)
timeFrame: Change from baseline in child attachment status at 33 weeks
Other outcomes:
measure: Addiction and Child Welfare Questionnaire (ACWQ)
timeFrame: Change from baseline in risk for relapse at 12 weeks
measure: Addiction and Child Welfare Questionnaire (ACWQ)
timeFrame: Change from baseline in risk for relapse at 33 weeks
measure: Brief Symptom Inventory
timeFrame: Change from baseline in psychiatric symptoms at 12 weeks
measure: Brief Symptom Inventory
timeFrame: Change from baseline in psychiatric symptoms at 33 weeks
measure: Beck Depression Inventory
timeFrame: Change from baseline in depression symptoms at 12 weeks
measure: Beck Depression Inventory
timeFrame: Change from baseline in depression symptoms at 33 weeks
Locations:
city: New Haven
country: United States
facility: The Moms 'n' Kids Program at the APT Foundation
state: Connecticut
Study officials:
References: