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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Nancy E. Suchman, Yale University
ClinicalTrials.gov Identifier:
NCT01240993
First received: November 5, 2010
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

Five years ago the investigators were funded to develop the Mothers and Toddlers Program or MTP (R01 DA17294 / Project Period: 8/20/04 - 12/31/09). MTP is the first parenting intervention developed for substance abusing mothers that is based on the principles of 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 the investigators need to conduct a Stage II randomized clinical trial. Materials include: the MTP treatment manual, instructions for conducting PEP - the comparison intervention, treatment fidelity scales and manual, MTP therapist training program, outcome assessments and measures. The investigators have also completed a randomized clinical trial - a preliminary test of the efficacy of MTP in comparison with the Parent Education Program (PEP), an individual supportive comparison intervention. Outcome data from the intention-to-treat sample of 47 randomized subjects shows that MTP led to greater improvement than PEP in all targeted parenting outcomes (capacity for reflective functioning, quality of maternal representations and caregiving behavior) and global psychiatric distress. Having met the objectives of the Stage I investigation and having evidence of MTP's feasibility and promise, the investigators now seek to conduct a formal definitive efficacy test of MTP in a full-scale Stage II randomized trial. In the Stage II investigation, the investigators will: (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.


Condition Intervention Phase
Parenting Capacities of Substance Abusing Mothers
Behavioral: Mentalization-Based Therapy for Substance Abusing Mothers
Behavioral: Parent Education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fostering Mothers' Emotionally-Responsive Parenting

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Parent Development Interview coded for maternal reflective functioning [ Time Frame: Post (Wk 16) ] [ Designated as safety issue: No ]
    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.

  • Working Model of the Child Interview (coded for representation quality) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Parent Development Interview coded for reflective functioning [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Parental Development Interview coded for reflective functioning [ Time Frame: Follow up (Wk 31) ] [ Designated as safety issue: No ]
    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.

  • Working Model of the Child Interview coded for representation quality [ Time Frame: Post (Wk 17) ] [ Designated as safety issue: No ]
    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.

  • Working Model of the Child Interview (coded for representation quality) [ Time Frame: Follow up (Wk 32) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • NCAST Teaching Task (Maternal Behavior) [ Time Frame: Baseline (Wk 2), Post-tx (Wk 18), Follow up (Wk 33) ] [ Designated as safety issue: No ]
    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.

  • NCAST Teaching Scales (Child Behavior) [ Time Frame: Baseline (Wk 2), Post-tx (Wk 18), Follow up (Wk 33) ] [ Designated as safety issue: No ]
    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.

  • Child Attachment Status [ Time Frame: Baseline (Wk 4), Post (Wk 19) ] [ Designated as safety issue: No ]
    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.

  • Beck Depression Inventory [ Time Frame: Wks 1, 5, 9, 13, 17, 21, 25, 29, 33 ] [ Designated as safety issue: Yes ]
    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).

  • Brief Symptom Inventory [ Time Frame: Wks 1, 5, 9, 13, 17, 21, 25, 29, 33 ] [ Designated as safety issue: Yes ]
    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.

  • Curiosity Box Paradigm [ Time Frame: Baseline (Wk 2), Post-tx (Wk 18), Follow up (Wk 33) ] [ Designated as safety issue: No ]
    . 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).


Estimated Enrollment: 150
Study Start Date: July 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. Sample pamphlet topics include safety-proofing the home, routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness. The intervention is conducted a clinic where mothers are enrolled in treatment for their substance abuse.
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 (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 (i.e., pamphlets do not overlap significantly with the MTP treatment approach). Sample pamphlet topics include safety-proofing the home, routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness. The intervention is conducted a clinic where mothers are enrolled in treatment for their substance abuse.
Experimental: Mentalization-Based Therapy for Substance Using Mothers
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: Mentalization-Based Therapy for Substance Abusing Mothers
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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240993

Contacts
Contact: Cindy L DeCoste, M.S. 203-285-1475 cindy.decoste@yale.edu
Contact: Lourdes de las Heras, M.S. 203-285-1473 ldonald@aptfoundation.org

Locations
United States, Connecticut
The Moms 'n' Kids Program at the APT Foundation Recruiting
New Haven, Connecticut, United States, 06511
Yale Psychosocial Substance Abuse Research Unit Recruiting
West Haven, Connecticut, United States, 06516
Contact: Cindy DeCoste, MS    203-285-1475    cindy.decoste@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Nancy E. Suchman, Ph.D. Yale University School of Medicine, Department of Psychiatry
  More Information

Publications:
Suchman, N., DeCoste, C., Castiglioni, N., McMahon, T., Rounsaville, B., & Mayes, L. (2010). The Mothers and Toddlers Program: An attachment-based parenting intervention for substance-using women: Post-treatment results from a randomized clinical trial, Attachment and Human Development, 12, 483-504.
Suchman, N., DeCoste, C., Leigh, D., & Borelli, J. (2010). Reflective functioning in mothers with drug use disorders: Implications for dyadic interactions with infants and toddlers. Attachment and Human Development, 12, 567-585.

Responsible Party: Nancy E. Suchman, Associate Professor in Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01240993     History of Changes
Other Study ID Numbers: 2R01DA017294
Study First Received: November 5, 2010
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
parenting intervention
mother-child relations
substance abuse
attachment
child development

ClinicalTrials.gov processed this record on July 31, 2014