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

July 12, 2021 updated by: Yale University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • The Moms 'n' Kids Program at the APT Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mothering From the Inside Out
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)
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).
Other Names:
  • Mothers and Toddlers Program
  • Emotionally-Responsive Parenting
Active Comparator: Parent Education
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
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 Names:
  • Mommy and Me Growing Together

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maternal Reflective Functioning coded using the Parent Development Interview
Time Frame: Change from baseline in reflective functioning at 12 weeks
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
Time Frame: Change from baseline in reflective functioning at 33 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal Sensitivity coded with Ruth Feldman's Coding Interactive Behavior (CIB) Scales
Time Frame: Change from baseline in maternal sensitivity at 12 weeks
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.
Change from baseline in maternal sensitivity at 12 weeks
Maternal Sensitivity coded with Ruth Feldman's Coding Interactive Behavior (CIB) Scales
Time Frame: Change from baseline in maternal sensitivity at 33 weeks
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.
Change from baseline in maternal sensitivity at 33 weeks
Maternal Caregiving Behavior coded with the Nursing Child Assessment Satellite Training (NCAST) Teaching Scales
Time Frame: Change from baseline in maternal caregiving behavior at 12 weeks
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.
Change from baseline in maternal caregiving behavior at 12 weeks
Maternal Caregiving Behavior coded with the Nursing Child Assessment Satellite Training (NCAST) Teaching Scales
Time Frame: Change from baseline in maternal caregiving behavior at 33 weeks
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.
Change from baseline in maternal caregiving behavior at 33 weeks
Child Attachment coded during the Strange Situation Paradigm (SSP)
Time Frame: Change from baseline in child attachment status at 12 weeks
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.
Change from baseline in child attachment status at 12 weeks
Child Attachment coded during the Strange Situation Paradigm (SSP)
Time Frame: Change from baseline in child attachment status at 33 weeks
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.
Change from baseline in child attachment status at 33 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Addiction and Child Welfare Questionnaire (ACWQ)
Time Frame: Change from baseline in risk for relapse at 12 weeks
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.
Change from baseline in risk for relapse at 12 weeks
Addiction and Child Welfare Questionnaire (ACWQ)
Time Frame: Change from baseline in risk for relapse at 33 weeks
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.
Change from baseline in risk for relapse at 33 weeks
Brief Symptom Inventory
Time Frame: Change from baseline in psychiatric symptoms at 12 weeks
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.
Change from baseline in psychiatric symptoms at 12 weeks
Brief Symptom Inventory
Time Frame: Change from baseline in psychiatric symptoms at 33 weeks
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.
Change from baseline in psychiatric symptoms at 33 weeks
Beck Depression Inventory
Time Frame: Change from baseline in depression symptoms at 12 weeks
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.
Change from baseline in depression symptoms at 12 weeks
Beck Depression Inventory
Time Frame: Change from baseline in depression symptoms at 33 weeks
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.
Change from baseline in depression symptoms at 33 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0407026890
  • 3R01DA017294 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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