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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nancy E. Suchman, Yale University
ClinicalTrials.gov Identifier:
NCT00319436
First received: April 26, 2006
Last updated: January 20, 2014
Last verified: January 2014
Results First Received: November 5, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Maternal Substance Use
Child Abuse and Neglect
Interventions: Behavioral: Mentalizing Therapy for Substance Using Mothers
Behavioral: Standard Parent Education for Substance Using Mothers

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All mothers enrolled in outpatient substance use treatment and caring for a child between birth and 36 months of age were eligible. Mothers were recruited via clinician referrals and self-referral. Mothers who were actively suicidal, homicidal, severely cognitively impaired, disengaged from their treatment or not fluent in English were excluded.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Mothers were informed that after completing a baseline assessment they would be randomly assigned to one of two parenting programs. Mothers were asked permission to access their clinic attendance records and urinary toxicity results over the course of the study.

Reporting Groups
  Description
Mentalizing Therapy for Mothers This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
Standard Parent Education This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.

Participant Flow:   Overall Study
    Mentalizing Therapy for Mothers     Standard Parent Education  
STARTED     23     24  
COMPLETED     17     17  
NOT COMPLETED     6     7  
Withdrawal by Subject                 6                 7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mentalizing Therapy for Mothers This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child’s emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child’s emotional needs.
Standard Parent Education This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
Total Total of all reporting groups

Baseline Measures
    Mentalizing Therapy for Mothers     Standard Parent Education     Total  
Number of Participants  
[units: participants]
  23     24     47  
Age  
[units: years]
Mean ± Standard Deviation
  31.43  ± 6.46     28.88  ± 6.50     30.16  ± 6.48  
Gender  
[units: participants]
     
Female     23     24     47  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     23     24     47  



  Outcome Measures
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1.  Primary:   Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)   [ Time Frame: post-treatment and 6-week follow up ]

2.  Primary:   Quality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)   [ Time Frame: post-treatment, 6-week follow up ]

3.  Secondary:   Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)   [ Time Frame: post-treatment, 6-week follow up ]

4.  Secondary:   Child Behavior (Assessed With the NCAST Teaching Scales)   [ Time Frame: post-treatment and 6-wk follow up ]

5.  Secondary:   Maternal Depression (Measured With the Beck Depression Inventory)   [ Time Frame: post-treatment and 6-wk follow up ]

6.  Secondary:   Maternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)   [ Time Frame: post-treatment and 6-wk follow up ]

7.  Secondary:   Maternal Substance Abuse (Assessed With Urine Toxicology Screens)   [ Time Frame: post-treatment and 6-wk follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Sample most representative of addicted mothers in mid-30’s, Caucasian, high school educated, unemployed, moderate involvement with child welfare. Caution in generalizing to higher risk mothers (adolescent mothers, ethnic minority,less educated).


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nancy Suchman, Ph.D., Associate Professor
Organization: Yale University School of Medicine, Department of Psychiatry and Yale Child Study Center
phone: 203-937-3486 ext 7430
e-mail: nancy.suchman@yale.edu


Publications of Results:
Suchman, N., DeCoste, & Mayes, L. (2009). The Mothers and Toddlers Program: An attachment-based intervention for mothers in substance abuse treatment. In C. Zeanah (Ed.), Handbook of infant mental health, 3rd edition, pp. 485-499. New York, NY: Guilford Press.
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).

Other Publications:

Responsible Party: Nancy E. Suchman, Yale University
ClinicalTrials.gov Identifier: NCT00319436     History of Changes
Other Study ID Numbers: R01 DA017294, R01 DA17294
Study First Received: April 26, 2006
Results First Received: November 5, 2010
Last Updated: January 20, 2014
Health Authority: United States: Federal Government