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

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.

Study Overview

• Status: Completed
• Conditions: Parenting Capacities of Substance Abusing Mothers
• Intervention / Treatment: Behavioral: Parent Education; Behavioral: Mothers and Toddlers Program

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Parent Education; 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.	Behavioral: Parent Education; 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.
Experimental: Mothers and Toddlers Program; 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.	Behavioral: Mothers and Toddlers Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Change at week 33 (follow up) from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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).	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).	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.	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).	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).	Change at week 33 (follow up) from baseline

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Nancy E. Suchman, Ph.D., Yale University School of Medicine, Department of Psychiatry

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: November 5, 2010
• First Submitted That Met QC Criteria: November 12, 2010
• First Posted (Estimate): November 15, 2010

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: substance abuse; attachment; child development; parenting intervention; mother-child relations
• Other Study ID Numbers: 0407026890-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No