NCT01240993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

5.2 years

First QC Date

November 5, 2010

Last Update Submit

March 31, 2020

Conditions

Keywords

parenting interventionmother-child relationssubstance abuseattachmentchild development

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Working Model of the Child Interview (coded for representation quality)

    Change at week 12 (post-treatment) from baseline

  • Working Model of the Child Interview (coded for representation quality)

    Change at week 33 (follow up) from baseline

  • NCAST Teaching Scales (Maternal Behavior)

    Change at week 12 (post-treatment) from baseline

  • NCAST Teaching Scales (Maternal Behavior)

    Change at week 33 (follow up) from baseline

  • NCAST Teaching Scales (Child Behavior)

    Change at week 12 (post-treatment) from baseline

  • +7 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Mothers and Toddlers Program

Interventions

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.

Mothers and Toddlers Program

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.

Parent Education

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Moms 'n' Kids Program at the APT Foundation

New Haven, Connecticut, 06511, United States

Location

Yale Psychosocial Substance Abuse Research Unit

West Haven, Connecticut, 06516, United States

Location

Related Publications (9)

  • 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.

    PMID: 20730641BACKGROUND
  • 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.

    PMID: 20931415BACKGROUND
  • 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.

    PMID: 22685361BACKGROUND
  • 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.

    PMID: 20057923BACKGROUND
  • 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.

    PMID: 23024442BACKGROUND
  • 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.

    PMID: 23049148BACKGROUND
  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Nancy E. Suchman, Ph.D.

    Yale University School of Medicine, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2010

First Posted

November 15, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

April 2, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations