AddictionNCT02955199
Stage III Community-based Efficacy Trial for Mothering From the Inside Out
A study testing Mothering From the Inside Out (MIO) and Parent Education in people with Addiction and Substance Abuse Drug Chronic, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Addiction, Substance Abuse Drug Chronic, Child Neglect
- What is being tested?
- Mothering From the Inside Out (MIO) and Parent Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Actively suicidal, homicidal, or severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
The Moms 'n' Kids Program at the APT Foundation
New Haven, Connecticut, 06511
About this study
Official title: 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.
Read the 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).
- Conditions
- Addiction, Substance Abuse Drug Chronic, Child Neglect, Child Neglect Emotional, Child Abuse, Parenting
- Being tested
- Mothering From the Inside Out (MIO), Parent Education
- Medical subject headings
- Behavior, Addictive, Substance Abuse, Intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mothering From the Inside Out (MIO)Behavioural
Also called Mothers and Toddlers Program, Emotionally-Responsive Parenting
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 EducationBehavioural
Also called Mommy and Me Growing Together
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Parent Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline in reflective functioning at 33 weeks
Secondary outcomes (6)
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.
Measured: Change from baseline in maternal sensitivity at 12 weeks
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.
Measured: Change from baseline in maternal sensitivity at 33 weeks
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.
Measured: Change from baseline in maternal caregiving behavior at 12 weeks
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.
Measured: Change from baseline in maternal caregiving behavior at 33 weeks
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.
Measured: Change from baseline in child attachment status at 12 weeks
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.
Measured: Change from baseline in child attachment status at 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startApr 2015
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955199
- Sponsor's protocol ID
- 0407026890
- Other IDs
- 3R01DA017294
- Status last verified
- Jul 2021
- First submitted
- 27 Oct 2016
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Mothers' Emotionally-Responsive Parenting: A Stage III Community-Based Efficacy Trial
- ClinicalTrials.gov ID
- NCT02955199
- Acronym / sponsor ID
- 0407026890
- Conditions
- Addiction, Substance Abuse Drug Chronic, Child Neglect, Child Neglect Emotional, Child Abuse, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2015
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothering From the Inside Out | Experimental | 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). |
| Parent Education | Active comparator | Behavioral: Parent EducationParent 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Actively suicidal, homicidal, or severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mothering From the Inside Out (MIO)Also: Mothers and Toddlers Program, Emotionally-Responsive ParentingMothering 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). | Behavioural | Mothering From the Inside Out |
| Parent EducationAlso: Mommy and Me Growing TogetherParent 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. | Behavioural | Parent Education |
Primary outcome
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.
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.
6 secondary outcomes
Maternal Sensitivity coded with Ruth Feldman's Coding Interactive Behavior (CIB) Scales
Time frame: 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 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 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
Child Attachment coded during the Strange Situation Paradigm (SSP)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mothering From the Inside Out (MIO) and Parent Education in people with Addiction and Substance Abuse Drug Chronic, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Reflective Functioning coded using the Parent Development Interview (time frame: Change from baseline in reflective functioning at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.