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

NCT02955199 | Completed DMC

• 2 other identifiers: 04070268903R01DA017294
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Maternal Reflective Functioning coded using the Parent Development Interview

  A one hour semi-structured interview that asks mothers to describe episodes with their child that typically require the capacity for reflective functioning. The interview is coded by a rater blind to all information about the mother and her treatment assignment. The protocol is assigned a score on a scale from -1 to 9 where higher scores indicate a better capacity for reflective functioning. A score of 5 indicates average reflective functioning and a score of 3 and lower represents absence of the capacity.

  Change from baseline in reflective functioning at 12 weeks

• Maternal Reflective Functioning coded using the Parent Development Interview

  A one hour semi-structured interview that asks mothers to describe episodes with their child that typically require the capacity for reflective functioning. The interview is coded by a rater blind to all information about the mother and her treatment assignment. The protocol is assigned a score on a scale from -1 to 9 where higher scores indicate a better capacity for reflective functioning. A score of 5 indicates average reflective functioning and a score of 3 and lower represents absence of the capacity.

  Change from baseline in reflective functioning at 33 weeks

Secondary Outcomes (6)

• Maternal Sensitivity coded with Ruth Feldman's Coding Interactive Behavior (CIB) Scales

  Change from baseline in maternal sensitivity at 12 weeks

• Maternal Sensitivity coded with Ruth Feldman's Coding Interactive Behavior (CIB) Scales

  Change from baseline in maternal sensitivity at 33 weeks

• Maternal Caregiving Behavior coded with the Nursing Child Assessment Satellite Training (NCAST) Teaching Scales

  Change from baseline in maternal caregiving behavior at 12 weeks

• Maternal Caregiving Behavior coded with the Nursing Child Assessment Satellite Training (NCAST) Teaching Scales

  Change from baseline in maternal caregiving behavior at 33 weeks

• Child Attachment coded during the Strange Situation Paradigm (SSP)

  Change from baseline in child attachment status at 12 weeks

Other Outcomes (6)

• Addiction and Child Welfare Questionnaire (ACWQ)

  Change from baseline in risk for relapse at 12 weeks

• Addiction and Child Welfare Questionnaire (ACWQ)

  Change from baseline in risk for relapse at 33 weeks

• Brief Symptom Inventory

  Change from baseline in psychiatric symptoms at 12 weeks

Study Arms (2)

Mothering From the Inside Out

EXPERIMENTAL

Mothering from the Inside Out (MIO) is a 12 session individual parenting therapy designed for mothers enrolled in treatment for drug and/or alcohol addiction and caring for a child between 11 and 60 months of age. MIO aims to promote their capacity for parental reflective functioning (the capacity to recognize and make sense of their own and their child's difficult emotions during challenging parenting situations).

Behavioral: Mothering From the Inside Out (MIO)

Parent Education

ACTIVE COMPARATOR

Parent Education (PE) is a 12 session individual parent counseling intervention designed for mothers enrolled in treatment for drug and/or alcohol addiction and caring for a child between 11 and 60 months of age. PE provides psycho-education about child development and parenting strategies typically available at community agencies on parenting. PE is designed to control for active treatment, treatment dose, and individualized intervention approach.

Behavioral: Parent Education

Interventions

Mothering From the Inside Out (MIO) BEHAVIORAL

Mothering from the Inside Out (MIO) is a 12 session individual parenting therapy designed for mothers enrolled in treatment for drug and/or alcohol addiction and caring for a child between 11 and 60 months of age. MIO aims to promote their capacity for parental reflective functioning (the capacity to recognize and make sense of their own and their child's difficult emotions during challenging parenting situations).

Also known as: Mothers and Toddlers Program, Emotionally-Responsive Parenting

Mothering From the Inside Out

Parent Education BEHAVIORAL

Parent Education (PE) is a 12 session individual parent counseling intervention designed for mothers enrolled in treatment for drug and/or alcohol addiction and caring for a child between 11 and 60 months of age. PE provides psycho-education about child development and parenting strategies typically available at community agencies on parenting. PE is designed to control for active treatment, treatment dose, and individualized intervention approach.

Also known as: Mommy and Me Growing Together

Parent Education

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Actively suicidal, homicidal, or severe cognitive impairment

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Moms 'n' Kids Program at the APT Foundation

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Behavior, Addictive; Substance Abuse, Intravenous

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 4, 2016
• Study Start: April 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: July 14, 2021

Record last verified: 2021-07

Locations

US (1)