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

Primary Purpose

Addiction, Substance Abuse Drug Chronic, Child Neglect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mothering From the Inside Out (MIO)
Parent Education
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Moms 'n' Kids Program at the APT Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mothering From the Inside Out

Parent Education

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Maternal Sensitivity coded with Ruth Feldman's Coding Interactive Behavior (CIB) Scales
Maternal behavior is observed during a 5 minute interaction with the target child during which they explore a set of novel toys together. Maternal Sensitivity Scale includes 12 items that are rated on a 5 point scale by a trained coder who is blind to treatment assignment and all other information about the mother-child dyad. The score range is 1 to 5 where a score of 2 and below indicates clinically significant problems and a score of 3 and higher is considered average to above average sensitivity.
Maternal Sensitivity coded with Ruth Feldman's Coding Interactive Behavior (CIB) Scales
Maternal behavior is observed during a 5 minute interaction with the target child during which they explore a set of novel toys together. Maternal Sensitivity Scale includes 12 items that are rated on a 5 point scale by a trained coder who is blind to treatment assignment and all other information about the mother-child dyad. The score range is 1 to 5 where a score of 2 and below indicates clinically significant problems and a score of 3 and higher is considered average to above average sensitivity.
Maternal Caregiving Behavior coded with the Nursing Child Assessment Satellite Training (NCAST) Teaching Scales
Maternal behavior is observed during a 5 minute interaction with the target child during which they explore a set of novel toys together. Maternal Sensitivity Scale includes 12 items that are rated on a 5 point scale by a trained coder who is blind to treatment assignment and all other information about the mother-child dyad. The score range is 1 to 5 where a score of 2 and below indicates clinically significant problems and a score of 3 and higher is considered average to above average sensitivity.
Maternal Caregiving Behavior coded with the Nursing Child Assessment Satellite Training (NCAST) Teaching Scales
Maternal behavior is observed during a 5 minute interaction with the target child during which they explore a set of novel toys together. Maternal Sensitivity Scale includes 12 items that are rated on a 5 point scale by a trained coder who is blind to treatment assignment and all other information about the mother-child dyad. The score range is 1 to 5 where a score of 2 and below indicates clinically significant problems and a score of 3 and higher is considered average to above average sensitivity.
Child Attachment coded during the Strange Situation Paradigm (SSP)
The SSP is an experimental paradigm designed to activate attachment-based stress in the child during a series of separations and reunions with mother. The assessment takes approximately 30 minutes to complete and is rated by a trained coder who is blind to treatment assignment and all other information about the mother-child dyad (except information about known disabilities in the child). The child receives a classification of Secure, Insecure-Avoidant, Insecure-Resistant or Disorganized. The ideal classification is Secure and the most clinically significant classification is Disorganized.
Child Attachment coded during the Strange Situation Paradigm (SSP)
The SSP is an experimental paradigm designed to activate attachment-based stress in the child during a series of separations and reunions with mother. The assessment takes approximately 30 minutes to complete and is rated by a trained coder who is blind to treatment assignment and all other information about the mother-child dyad (except information about known disabilities in the child). The child receives a classification of Secure, Insecure-Avoidant, Insecure-Resistant or Disorganized. The ideal classification is Secure and the most clinically significant classification is Disorganized.

Full Information

First Posted
October 27, 2016
Last Updated
July 12, 2021
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02955199
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mothering From the Inside Out
Arm Type
Experimental
Arm Description
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).
Arm Title
Parent Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mothering From the Inside Out (MIO)
Other Intervention Name(s)
Mothers and Toddlers Program, Emotionally-Responsive Parenting
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Parent Education
Other Intervention Name(s)
Mommy and Me Growing Together
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal Reflective Functioning coded using the Parent Development Interview
Description
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.
Time Frame
Change from baseline in reflective functioning at 12 weeks
Title
Maternal Reflective Functioning coded using the Parent Development Interview
Description
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.
Time Frame
Change from baseline in reflective functioning at 33 weeks
Secondary Outcome Measure Information:
Title
Maternal Sensitivity coded with Ruth Feldman's Coding Interactive Behavior (CIB) Scales
Description
Maternal behavior is observed during a 5 minute interaction with the target child during which they explore a set of novel toys together. Maternal Sensitivity Scale includes 12 items that are rated on a 5 point scale by a trained coder who is blind to treatment assignment and all other information about the mother-child dyad. The score range is 1 to 5 where a score of 2 and below indicates clinically significant problems and a score of 3 and higher is considered average to above average sensitivity.
Time Frame
Change from baseline in maternal sensitivity at 12 weeks
Title
Maternal Sensitivity coded with Ruth Feldman's Coding Interactive Behavior (CIB) Scales
Description
Maternal behavior is observed during a 5 minute interaction with the target child during which they explore a set of novel toys together. Maternal Sensitivity Scale includes 12 items that are rated on a 5 point scale by a trained coder who is blind to treatment assignment and all other information about the mother-child dyad. The score range is 1 to 5 where a score of 2 and below indicates clinically significant problems and a score of 3 and higher is considered average to above average sensitivity.
Time Frame
Change from baseline in maternal sensitivity at 33 weeks
Title
Maternal Caregiving Behavior coded with the Nursing Child Assessment Satellite Training (NCAST) Teaching Scales
Description
Maternal behavior is observed during a 5 minute interaction with the target child during which they explore a set of novel toys together. Maternal Sensitivity Scale includes 12 items that are rated on a 5 point scale by a trained coder who is blind to treatment assignment and all other information about the mother-child dyad. The score range is 1 to 5 where a score of 2 and below indicates clinically significant problems and a score of 3 and higher is considered average to above average sensitivity.
Time Frame
Change from baseline in maternal caregiving behavior at 12 weeks
Title
Maternal Caregiving Behavior coded with the Nursing Child Assessment Satellite Training (NCAST) Teaching Scales
Description
Maternal behavior is observed during a 5 minute interaction with the target child during which they explore a set of novel toys together. Maternal Sensitivity Scale includes 12 items that are rated on a 5 point scale by a trained coder who is blind to treatment assignment and all other information about the mother-child dyad. The score range is 1 to 5 where a score of 2 and below indicates clinically significant problems and a score of 3 and higher is considered average to above average sensitivity.
Time Frame
Change from baseline in maternal caregiving behavior at 33 weeks
Title
Child Attachment coded during the Strange Situation Paradigm (SSP)
Description
The SSP is an experimental paradigm designed to activate attachment-based stress in the child during a series of separations and reunions with mother. The assessment takes approximately 30 minutes to complete and is rated by a trained coder who is blind to treatment assignment and all other information about the mother-child dyad (except information about known disabilities in the child). The child receives a classification of Secure, Insecure-Avoidant, Insecure-Resistant or Disorganized. The ideal classification is Secure and the most clinically significant classification is Disorganized.
Time Frame
Change from baseline in child attachment status at 12 weeks
Title
Child Attachment coded during the Strange Situation Paradigm (SSP)
Description
The SSP is an experimental paradigm designed to activate attachment-based stress in the child during a series of separations and reunions with mother. The assessment takes approximately 30 minutes to complete and is rated by a trained coder who is blind to treatment assignment and all other information about the mother-child dyad (except information about known disabilities in the child). The child receives a classification of Secure, Insecure-Avoidant, Insecure-Resistant or Disorganized. The ideal classification is Secure and the most clinically significant classification is Disorganized.
Time Frame
Change from baseline in child attachment status at 33 weeks
Other Pre-specified Outcome Measures:
Title
Addiction and Child Welfare Questionnaire (ACWQ)
Description
The Addiction and Child Welfare Questionnaire is a 12 item scale that we developed to assess maternal risk for relapse. Nine items ask about recent substance use and cravings and 3 items ask about child custody status (a potential trigger for relapse). Items are rated on a binary scale and scores can range from 0 to 24 with higher scores representing higher risk for/incidence of relapse. There is no established clinical cut off for the scale.
Time Frame
Change from baseline in risk for relapse at 12 weeks
Title
Addiction and Child Welfare Questionnaire (ACWQ)
Description
The Addiction and Child Welfare Questionnaire is a 12 item scale that we developed to assess maternal risk for relapse. Nine items ask about recent substance use and cravings and 3 items ask about child custody status (a potential trigger for relapse). Items are rated on a binary scale and scores can range from 0 to 24 with higher scores representing higher risk for/incidence of relapse. There is no established clinical cut off for the scale.
Time Frame
Change from baseline in risk for relapse at 33 weeks
Title
Brief Symptom Inventory
Description
The Brief Symptom Inventory is a well known 53-item self-report measure rated on a 4 point scale that assesses current psychiatric symptoms. Scores can range from 0 to 212. We use the T Score conversion of the Global Severity Index Composite scale to evaluate fluctuations in maternal psychiatric distress across the study. T Scores can range from 1 to 100 where a score of 60 and above indicates clinically significant psychiatric distress.
Time Frame
Change from baseline in psychiatric symptoms at 12 weeks
Title
Brief Symptom Inventory
Description
The Brief Symptom Inventory is a well known 53-item self-report measure rated on a 4 point scale that assesses current psychiatric symptoms. Scores can range from 0 to 212. We use the T Score conversion of the Global Severity Index Composite scale to evaluate fluctuations in maternal psychiatric distress across the study. T Scores can range from 1 to 100 where a score of 60 and above indicates clinically significant psychiatric distress.
Time Frame
Change from baseline in psychiatric symptoms at 33 weeks
Title
Beck Depression Inventory
Description
The Beck Depression Inventory is a well known 21 item self-report measure that assesses current depressive symptoms on a 3 point Likert Scale. We use the Total Depression Score to evaluate fluctuations in maternal depression. Scores range from 0 to 63 where a score of 29 or greater indicates clinically significant depression.
Time Frame
Change from baseline in depression symptoms at 12 weeks
Title
Beck Depression Inventory
Description
The Beck Depression Inventory is a well known 21 item self-report measure that assesses current depressive symptoms on a 3 point Likert Scale. We use the Total Depression Score to evaluate fluctuations in maternal depression. Scores range from 0 to 63 where a score of 29 or greater indicates clinically significant depression.
Time Frame
Change from baseline in depression symptoms at 33 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The Moms 'n' Kids Program at the APT Foundation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

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

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