Clinical trial NCT01240993: Trial of Mentalization-Based Therapy for Substance Using Mothers of Infants and Toddlers
Official title: Fostering Mothers' Emotionally-Responsive Parenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting Capacities of Substance Abusing Mothers
Keywords: parenting intervention
mother-child relations
substance abuse
attachment
child development
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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).

Primary outcomes:
measure: Parent Development Interview coded for maternal reflective functioning
timeFrame: Change at week 12 (post-treatment) from baseline
measure: Parent Development Interview coded for maternal reflective functioning
timeFrame: Change at week 33 (follow up) from baseline
Secondary outcomes:
measure: Working Model of the Child Interview (coded for representation quality)
timeFrame: Change at week 12 (post-treatment) from baseline
measure: Working Model of the Child Interview (coded for representation quality)
timeFrame: Change at week 33 (follow up) from baseline
measure: NCAST Teaching Scales (Maternal Behavior)
timeFrame: Change at week 12 (post-treatment) from baseline
measure: NCAST Teaching Scales (Maternal Behavior)
timeFrame: Change at week 33 (follow up) from baseline
measure: NCAST Teaching Scales (Child Behavior)
timeFrame: Change at week 12 (post-treatment) from baseline
measure: NCAST Teaching Scales (Child Behavior)
timeFrame: Change at week 33 (follow up) from baseline
measure: Child Attachment Status
timeFrame: Change at week 12 (post-treatment) from baseline
measure: Beck Depression Inventory
timeFrame: Change at week 12 (post-treatment) from baseline
measure: Beck Depression Inventory
timeFrame: Change at week 33 (follow up) from baseline
measure: Brief Symptom Inventory
timeFrame: Change at week 33 (follow up) from baseline
measure: Curiosity Box Paradigm
timeFrame: Change at week 12 (post-treatment) from baseline
measure: Curiosity Box Paradigm
timeFrame: Change at week 33 (follow up) from baseline
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The Moms 'n' Kids Program at the APT Foundation
state: Connecticut
city: West Haven
country: United States
facility: Yale Psychosocial Substance Abuse Research Unit
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine, Department of Psychiatry
name: Nancy E. Suchman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.