Stage III Community-based Efficacy Trial for Mothering From the Inside Out
Condition: 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
MeSH terms: Substance-Related Disorders; Substance Abuse, Intravenous
Study type: Interventional

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).
    

Intervention name(s): Mothering From the Inside Out (MIO); Parent Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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).; 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.
Other intervention name(s): Mothers and Toddlers Program; Emotionally-Responsive Parenting; Mommy and Me Growing Together
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment