Parenting Capacities of Substance Abusing MothersNCT01240993

Trial of Mentalization-Based Therapy for Substance Using Mothers of Infants and Toddlers

A study testing Mothers and Toddlers Program and Parent Education in people with Parenting Capacities of Substance Abusing Mothers, run by Yale University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A formal randomized efficacy trial testing the Mothers and Toddlers' program, an attachment-based parenting intervention for mothers enrolled in addiction treatment and caring for young children. Read more about this study

Who is it for?: Ages 21 to 45 years, women only
Conditions the study is for: Parenting Capacities of Substance Abusing Mothers
What is being tested?: Mothers and Toddlers Program and Parent Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 2 sitesUnited States
Study dates: Jul 2010to Sep 2015
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 21 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

All mothers ages 21 to 45 years, who are enrolled in treatment at one of the five APT Foundation clinics and caring for a biological child between 12 and 60 months of age will be eligible to participate.

Who cannot join

Severe mental health problems (e.g., suicidal, homicidal, psychosis, thought disorder)
Severe cognitive impairment
Inability to speak English
Target child with serious illness or significant developmental delay (e.g., cognitive, language, or motor).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

The Moms 'n' Kids Program at the APT Foundation
New Haven, Connecticut, 06511
Yale Psychosocial Substance Abuse Research Unit
West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: Fostering Mothers' Emotionally-Responsive Parenting

A formal randomized efficacy trial testing the Mothers and Toddlers' program, an attachment-based parenting intervention for mothers enrolled in addiction treatment and caring for young children.

Read the detailed description

Five years ago the investigators were funded to develop the Mothers and Toddlers Program (MTP; R01 DA17294 / Project Period: 8/20/04 - 12/31/09). MTP is the first parenting intervention developed for substance abusing mothers based on the attachment theory. It is also the only parenting intervention for substance abusing mothers that has led to improvement in maternal caregiving sensitivity and responsiveness to infant and toddler distress in observed lab-based interactions. The investigators now have all the research materials to conduct a Stage II randomized clinical trial including a treatment manual, treatment fidelity scales therapist training program and outcome measures. In this Stage II formal efficacy trial, the investigators (1) Introduce new measures of dyadic adjustment and child attachment, (2) Add an 18 week follow up period to test for sustained treatment effects, (3) Measure major constructs (reflective functioning, representations, dyadic adjustment, and child attachment) when they are expected to change, (4) Examine temporal mechanisms of change proposed in the MTP treatment model (5) Determine whether improvements in dyadic adjustment reduces incidence of relapse, (6) Broaden the MTP therapist pool by training four new therapists and (7) Broaden the coding pool by training 3 additional coders per measure. One hundred and fifty mothers caring for children ages 12 to 60 months of age will be recruited from outpatient substance abuse treatment services at the APT Foundation into the intention-to-treat sample and will be randomized to 12 weeks of MTP vs. PEP and followed for 33 weeks.

Conditions: Parenting Capacities of Substance Abusing Mothers
Being tested: Mothers and Toddlers Program, Parent Education
Keywords: parenting intervention, mother-child relations, substance abuse, attachment, child development
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mothers and Toddlers ProgramBehavioural
This intervention is a short-term attachment-based parenting therapy for substance using mothers of young children that emphasizes the development of the capacity for mentalizing.
Parent EducationBehavioural
PE was developed to represent parent education and support that is typically available to mothers with substance use problems who are at high risk for neglecting their young children. Mothers enrolled in PEP will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs and a choice of pamphlets on age-related parenting topics.

Study groups in NCT01240993
Study group	Role	What they receive
Parent Education	Active comparator	PE was developed to represent parent education and support that is typically available to mothers with substance use problems who are at high risk for neglecting their young children. Mothers enrolled in PEP will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will also provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed specifically for this study. Receives: Behavioral: Parent Education
Mothers and Toddlers Program	Experimental	This intervention is an introductory, short-term, supportive, psychodynamic therapy for substance using mothers of young children that emphasizes the development of the capacity for mentalizing. Mothers meet with an individual, MBT-trained psychodynamically-oriented therapist for 12 sessions. The intervention is conducted a clinic where mothers are enrolled in treatment for their substance abuse. Receives: Behavioral: Mothers and Toddlers Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Parent Development Interview coded for maternal reflective functioning
The Parent Development Interview (PDI; Slade, Aber, Berger, Bresgi, \& Kaplan, 2002) was used to measure maternal capacity to mentalize about her own and her child's behavior. The PDI is a 1 hour semi-structured interview designed to elicit the mother's narrative about commonly occurring, emotionally-challenging aspects of parenting. A rating of 1 indicates a absence of recognition of mental states. A rating of 3 indicates a limited capacity to acknowledge mental states. A rating of 5 indicates the presence of a rudimentary capacity for reflective functioning.
Measured: Change at week 12 (post-treatment) from baseline
Parent Development Interview coded for maternal reflective functioning
The Parent Development Interview (PDI; Slade, Aber, Berger, Bresgi, \& Kaplan, 2002) was used to measure maternal capacity to mentalize about her own and her child's behavior. The PDI is a 1 hour semi-structured interview designed to elicit the mother's narrative about commonly occurring, emotionally-challenging aspects of parenting. A rating of 1 indicates a absence of recognition of mental states. A rating of 3 indicates a limited capacity to acknowledge mental states. A rating of 5 indicates the presence of a rudimentary capacity for reflective functioning.
Measured: Change at week 33 (follow up) from baseline

Secondary outcomes (12)

Working Model of the Child Interview (coded for representation quality)
The Working Model of the Child Interview (WMCI; Zeanah \& Benoit, 1993) is a 1.5 hour interview used to elicit a narrative description of the mother's perceptions of her child and their relationship. The rater was trained by the to reliably code 6e qualitative subscales Openness, Richness, Coherence, Caregiving Sensitivity and Acceptance and Involvement. On the mean of six subscales, a score of three is considered to represent average representational quality, scores of 1 and 2 are considered to represent clinical risk and scores of 4 and 5 are considered to represent optimal quality.
Measured: Change at week 12 (post-treatment) from baseline
Working Model of the Child Interview (coded for representation quality)
The Working Model of the Child Interview (WMCI; Zeanah \& Benoit, 1993) is a 1.5 hour interview used to elicit a narrative description of the mother's perceptions of her child and their relationship. The rater was trained by the to reliably code 6e qualitative subscales Openness, Richness, Coherence, Caregiving Sensitivity and Acceptance and Involvement. On the mean of six subscales, a score of three is considered to represent average representational quality, scores of 1 and 2 are considered to represent clinical risk and scores of 4 and 5 are considered to represent optimal quality.
Measured: Change at week 33 (follow up) from baseline
NCAST Teaching Scales (Maternal Behavior)
The NCAST Teaching Scale (Barnard \& Eyres, 1979) is a standardized, 73 item tool used to observe and rate quality of interactions with children birth to 36 months. Mothers choose a task to teach the child in a 5 minute teaching session. Maternal behavior is coded on 4 dimensions: Sensitivity to Cues, Response to Distress, Social-Emotional Growth Fostering, \& Cognitive Growth Fostering. The Total Caregiver Score is the sum of the 4 subscale scores. The Total Caregiver Contingency Score is the sum of 20 items from the 4 subscales that involve the caregiver's contingent response to child cues.
Measured: Change at week 12 (post-treatment) from baseline
NCAST Teaching Scales (Maternal Behavior)
The NCAST Teaching Scale (Barnard \& Eyres, 1979) is a standardized, 73 item tool used to observe and rate quality of interactions with children birth to 36 months. Mothers choose a task to teach the child in a 5 minute teaching session. Maternal behavior is coded on 4 dimensions: Sensitivity to Cues, Response to Distress, Social-Emotional Growth Fostering, \& Cognitive Growth Fostering. The Total Caregiver Score is the sum of the 4 subscale scores. The Total Caregiver Contingency Score is the sum of 20 items from the 4 subscales that involve the caregiver's contingent response to child cues.
Measured: Change at week 33 (follow up) from baseline
NCAST Teaching Scales (Child Behavior)
Child behavior with the mother was assessed using the Clarity of Cues and the Responsiveness to Caregiver Subscales from the NCAST Teaching Scales. The Child Total Score is the sum of the 2 scales. The Child Contingency Score is the sum of 12 contingent items from the 2 scales.
Measured: Change at week 12 (post-treatment) from baseline
NCAST Teaching Scales (Child Behavior)
Child behavior with the mother was assessed using the Clarity of Cues and the Responsiveness to Caregiver Subscales from the NCAST Teaching Scales. The Child Total Score is the sum of the 2 scales. The Child Contingency Score is the sum of 12 contingent items from the 2 scales.
Measured: Change at week 33 (follow up) from baseline
Child Attachment Status
We will use the standard 8-episode protocol Strange Situation protocol. Each child will receive a classification of secure, insecure or disorganized for each time point.
Measured: Change at week 12 (post-treatment) from baseline
Beck Depression Inventory
The Beck Depression Inventory (BDI; Beck, Steer, \& Brown, 1996) was used to assess maternal symptoms of depression. The BDI is a widely used 21-item questionnaire rated on a 4-point scale and yields a total score ranging from 0 to 63: scores between 13 and 19 indicate mild depression; scores between 20 and 28 indicate moderate levels of depression, and scores between 29 and 63 indicate severe levels of depression (Beck et al., 1996).
Measured: Change at week 12 (post-treatment) from baseline
Beck Depression Inventory
The Beck Depression Inventory (BDI; Beck, Steer, \& Brown, 1996) was used to assess maternal symptoms of depression. The BDI is a widely used 21-item questionnaire rated on a 4-point scale and yields a total score ranging from 0 to 63: scores between 13 and 19 indicate mild depression; scores between 20 and 28 indicate moderate levels of depression, and scores between 29 and 63 indicate severe levels of depression (Beck et al., 1996).
Measured: Change at week 33 (follow up) from baseline
Brief Symptom Inventory
The Brief Symptom Inventory (BSI; Derogatis, 1993) was used to assess maternal global psychiatric distress. The BSI is a standardized, widely used, 53-item, 5-point, self-report measure of psychopathology. The composite Global Severity Index (GSI) measures current overall symptomatology across multiple domains and has demonstrated good reliability and validity (Derogatis, 1993). T scores above 60 on the GSI indicate risk for a clinical disorder.
Measured: Change at week 33 (follow up) from baseline
Curiosity Box Paradigm
. We will use the Curiosity Box Paradigm (Mayes et al., 1993) to assess dyadic adjustment under circumstances of mild uncertainty (i.e., during the child's exploration of unfamiliar toys/objects). Children will explore a box of 9 novel toys or objects (that they are unlikely to have seen before) after an initial 5 minute warm up period with one box of 9 familiar toys. Maternal, child and dyadic behavior will be assessed with the Coding Interaction Behavior Scales (Feldman, 1998).
Measured: Change at week 12 (post-treatment) from baseline
Curiosity Box Paradigm
. We will use the Curiosity Box Paradigm (Mayes et al., 1993) to assess dyadic adjustment under circumstances of mild uncertainty (i.e., during the child's exploration of unfamiliar toys/objects). Children will explore a box of 9 novel toys or objects (that they are unlikely to have seen before) after an initial 5 minute warm up period with one box of 9 familiar toys. Maternal, child and dyadic behavior will be assessed with the Coding Interaction Behavior Scales (Feldman, 1998).
Measured: Change at week 33 (follow up) from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Sep 2015

First posted15 Nov 2010 (estimated)
Study startJul 2010
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Parenting Capacities of Substance Abusing MothersStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01240993
Sponsor's protocol ID: 0407026890-C
Status last verified: Mar 2020
First submitted: 5 Nov 2010
Last updated: 2 Apr 2020
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Suchman NE, DeCoste C, Castiglioni N, McMahon TJ, Rounsaville B, Mayes L. The Mothers and Toddlers Program, an attachment-based parenting intervention for substance using women: post-treatment results from a randomized clinical pilot. Attach Hum Dev. 2010 Sep;12(5):483-504. doi: 10.1080/14616734.2010.501983.
PubMed 20730641
Suchman NE, DeCoste C, Leigh D, Borelli J. Reflective functioning in mothers with drug use disorders: implications for dyadic interactions with infants and toddlers. Attach Hum Dev. 2010 Nov;12(6):567-85. doi: 10.1080/14616734.2010.501988.
PubMed 20931415
Suchman NE, Decoste C, McMahon TJ, Rounsaville B, Mayes L. THE MOTHERS AND TODDLERS PROGRAM, AN ATTACHMENT-BASED PARENTING INTERVENTION FOR SUBSTANCE-USING WOMEN: RESULTS AT 6-WEEK FOLLOW-UP IN A RANDOMIZED CLINICAL PILOT. Infant Ment Health J. 2011 Jul;32(4):427-449. doi: 10.1002/imhj.20303. Epub 2011 Jun 14.
PubMed 22685361
Suchman N, Decoste C, Castiglioni N, Legow N, Mayes L. THE MOTHERS AND TODDLERS PROGRAM: Preliminary Findings From an Attachment-Based Parenting Intervention for Substance-Abusing Mothers. Psychoanal Psychol. 2008 Jul 1;25(3):499-517. doi: 10.1037/0736-9735.25.3.499.
PubMed 20057923
Suchman NE, Decoste C, Rosenberger P, McMahon TJ. ATTACHMENT-BASED INTERVENTION FOR SUBSTANCE-USING MOTHERS: A PRELIMINARY TEST OF THE PROPOSED MECHANISMS OF CHANGE. Infant Ment Health J. 2012 Jul 1;33(4):360-371. doi: 10.1002/imhj.21311. Epub 2012 Apr 24.
PubMed 23024442
Borelli JL, West JL, Decoste C, Suchman NE. EMOTIONALLY AVOIDANT LANGUAGE IN THE PARENTING INTERVIEWS OF SUBSTANCE-DEPENDENT MOTHERS: ASSOCIATIONS WITH REFLECTIVE FUNCTIONING, RECENT SUBSTANCE USE, AND PARENTING BEHAVIOR. Infant Ment Health J. 2012;33(5):506-519. doi: 10.1002/imhj.21340. Epub 2012 May 22.
PubMed 23049148
Suchman NE, DeCoste CL, McMahon TJ, Dalton R, Mayes LC, Borelli J. Mothering From the Inside Out: Results of a second randomized clinical trial testing a mentalization-based intervention for mothers in addiction treatment. Dev Psychopathol. 2017 May;29(2):617-636. doi: 10.1017/S0954579417000220.
PubMed 28401850
Suchman NE. Mothering from the Inside Out: A mentalization-based therapy for mothers in treatment for drug addiction. Int J Birth Parent Educ. 2016 Jul;3(4):19-24.
PubMed 27840685
Suchman NE, DeCoste C, Borelli JL, McMahon TJ. Does improvement in maternal attachment representations predict greater maternal sensitivity, child attachment security and lower rates of relapse to substance use? A second test of Mothering from the Inside Out treatment mechanisms. J Subst Abuse Treat. 2018 Feb;85:21-30. doi: 10.1016/j.jsat.2017.11.006. Epub 2017 Nov 21.
PubMed 29291768

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fostering Mothers' Emotionally-Responsive Parenting
ClinicalTrials.gov ID: NCT01240993
Acronym / sponsor ID: 0407026890-C
Conditions: Parenting Capacities of Substance Abusing Mothers
Keywords: parenting intervention, mother-child relations, substance abuse, attachment, child development
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Study start: Jul 2010
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 15 Nov 2010 (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.

A formal randomized efficacy trial testing the Mothers and Toddlers' program, an attachment-based parenting intervention for mothers enrolled in addiction treatment and caring for young children.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Parent Education	Active comparator	Behavioral: Parent EducationPE was developed to represent parent education and support that is typically available to mothers with substance use problems who are at high risk for neglecting their young children. Mothers enrolled in PEP will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will also provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed specifically for this study.
Mothers and Toddlers Program	Experimental	Behavioral: Mothers and Toddlers ProgramThis intervention is an introductory, short-term, supportive, psychodynamic therapy for substance using mothers of young children that emphasizes the development of the capacity for mentalizing. Mothers meet with an individual, MBT-trained psychodynamically-oriented therapist for 12 sessions. The intervention is conducted a clinic where mothers are enrolled in treatment for their substance abuse.

Who may qualify

Ages: 21 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

All mothers ages 21 to 45 years, who are enrolled in treatment at one of the five APT Foundation clinics and caring for a biological child between 12 and 60 months of age will be eligible to participate.

Key exclusion criteria (4 listed)

Severe mental health problems (e.g., suicidal, homicidal, psychosis, thought disorder)
Severe cognitive impairment
Inability to speak English
Target child with serious illness or significant developmental delay (e.g., cognitive, language, or motor).

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
Mothers and Toddlers ProgramThis intervention is a short-term attachment-based parenting therapy for substance using mothers of young children that emphasizes the development of the capacity for mentalizing.	Behavioural	Mothers and Toddlers Program
Parent EducationPE was developed to represent parent education and support that is typically available to mothers with substance use problems who are at high risk for neglecting their young children. Mothers enrolled in PEP will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs and a choice of pamphlets on age-related parenting topics.	Behavioural	Parent Education

Primary outcome

Parent Development Interview coded for maternal reflective functioning
Time frame: Change at week 12 (post-treatment) from baseline
The Parent Development Interview (PDI; Slade, Aber, Berger, Bresgi, \& Kaplan, 2002) was used to measure maternal capacity to mentalize about her own and her child's behavior. The PDI is a 1 hour semi-structured interview designed to elicit the mother's narrative about commonly occurring, emotionally-challenging aspects of parenting. A rating of 1 indicates a absence of recognition of mental states. A rating of 3 indicates a limited capacity to acknowledge mental states. A rating of 5 indicates the presence of a rudimentary capacity for reflective functioning.
Parent Development Interview coded for maternal reflective functioning
Time frame: Change at week 33 (follow up) from baseline
The Parent Development Interview (PDI; Slade, Aber, Berger, Bresgi, \& Kaplan, 2002) was used to measure maternal capacity to mentalize about her own and her child's behavior. The PDI is a 1 hour semi-structured interview designed to elicit the mother's narrative about commonly occurring, emotionally-challenging aspects of parenting. A rating of 1 indicates a absence of recognition of mental states. A rating of 3 indicates a limited capacity to acknowledge mental states. A rating of 5 indicates the presence of a rudimentary capacity for reflective functioning.

12 secondary outcomes

Working Model of the Child Interview (coded for representation quality)
Time frame: Change at week 12 (post-treatment) from baseline
Working Model of the Child Interview (coded for representation quality)
Time frame: Change at week 33 (follow up) from baseline
NCAST Teaching Scales (Maternal Behavior)
Time frame: Change at week 12 (post-treatment) from baseline
NCAST Teaching Scales (Maternal Behavior)
Time frame: Change at week 33 (follow up) from baseline
NCAST Teaching Scales (Child Behavior)
Time frame: Change at week 12 (post-treatment) from baseline
NCAST Teaching Scales (Child Behavior)
Time frame: Change at week 33 (follow up) from baseline
Child Attachment Status
Time frame: Change at week 12 (post-treatment) from baseline
Beck Depression Inventory
Time frame: Change at week 12 (post-treatment) from baseline
Beck Depression Inventory
Time frame: Change at week 33 (follow up) from baseline
Brief Symptom Inventory
Time frame: Change at week 33 (follow up) from baseline
Curiosity Box Paradigm
Time frame: Change at week 12 (post-treatment) from baseline
Curiosity Box Paradigm
Time frame: Change at week 33 (follow up) from baseline

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 2 Apr 2020.
Background: PubMed 20730641Suchman NE, DeCoste C, Castiglioni N, McMahon TJ, Rounsaville B, Mayes L. The Mothers and Toddlers Program, an attachment-based parenting intervention for substance using women: post-treatment results from a randomized clinical pilot. Attach Hum Dev. 2010 Sep;12(5):483-504. doi: 10.1080/14616734.2010.501983.
Background: PubMed 20931415Suchman NE, DeCoste C, Leigh D, Borelli J. Reflective functioning in mothers with drug use disorders: implications for dyadic interactions with infants and toddlers. Attach Hum Dev. 2010 Nov;12(6):567-85. doi: 10.1080/14616734.2010.501988.
Background: PubMed 22685361Suchman NE, Decoste C, McMahon TJ, Rounsaville B, Mayes L. THE MOTHERS AND TODDLERS PROGRAM, AN ATTACHMENT-BASED PARENTING INTERVENTION FOR SUBSTANCE-USING WOMEN: RESULTS AT 6-WEEK FOLLOW-UP IN A RANDOMIZED CLINICAL PILOT. Infant Ment Health J. 2011 Jul;32(4):427-449. doi: 10.1002/imhj.20303. Epub 2011 Jun 14.
Background: PubMed 20057923Suchman N, Decoste C, Castiglioni N, Legow N, Mayes L. THE MOTHERS AND TODDLERS PROGRAM: Preliminary Findings From an Attachment-Based Parenting Intervention for Substance-Abusing Mothers. Psychoanal Psychol. 2008 Jul 1;25(3):499-517. doi: 10.1037/0736-9735.25.3.499.
Background: PubMed 23024442Suchman NE, Decoste C, Rosenberger P, McMahon TJ. ATTACHMENT-BASED INTERVENTION FOR SUBSTANCE-USING MOTHERS: A PRELIMINARY TEST OF THE PROPOSED MECHANISMS OF CHANGE. Infant Ment Health J. 2012 Jul 1;33(4):360-371. doi: 10.1002/imhj.21311. Epub 2012 Apr 24.
Background: PubMed 23049148Borelli JL, West JL, Decoste C, Suchman NE. EMOTIONALLY AVOIDANT LANGUAGE IN THE PARENTING INTERVIEWS OF SUBSTANCE-DEPENDENT MOTHERS: ASSOCIATIONS WITH REFLECTIVE FUNCTIONING, RECENT SUBSTANCE USE, AND PARENTING BEHAVIOR. Infant Ment Health J. 2012;33(5):506-519. doi: 10.1002/imhj.21340. Epub 2012 May 22.
Results publication: PubMed 28401850Suchman NE, DeCoste CL, McMahon TJ, Dalton R, Mayes LC, Borelli J. Mothering From the Inside Out: Results of a second randomized clinical trial testing a mentalization-based intervention for mothers in addiction treatment. Dev Psychopathol. 2017 May;29(2):617-636. doi: 10.1017/S0954579417000220.
Results publication: PubMed 27840685Suchman NE. Mothering from the Inside Out: A mentalization-based therapy for mothers in treatment for drug addiction. Int J Birth Parent Educ. 2016 Jul;3(4):19-24.
Results publication: PubMed 29291768Suchman NE, DeCoste C, Borelli JL, McMahon TJ. Does improvement in maternal attachment representations predict greater maternal sensitivity, child attachment security and lower rates of relapse to substance use? A second test of Mothering from the Inside Out treatment mechanisms. J Subst Abuse Treat. 2018 Feb;85:21-30. doi: 10.1016/j.jsat.2017.11.006. Epub 2017 Nov 21.
Individual participant dataSharing planned: No

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.

Nancy E. Suchman, Ph.D. principal investigator

Yale University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mothers and Toddlers Program and Parent Education in people with Parenting Capacities of Substance Abusing Mothers, run by Yale University at 2 sites 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 1 inclusion and 4 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 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Parent Development Interview coded for maternal reflective functioning (time frame: Change at week 12 (post-treatment) from baseline). 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?

On the ClinicalTrials.gov record for NCT01240993, which also lists 9 linked publications.

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 2 Apr 2020.