Clinical trial NCT00319436: Stage I Randomized 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: Maternal Substance Use
Child Abuse and Neglect
Keywords: parenting intervention
family intervention
maternal substance abuse
mother-child relations
parent-child relations
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-04-27
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this Stage I therapy development study will be to manualize and test the preliminary efficacy of a parenting intervention for drug dependent mothers that aims to foster their ability to recognize children's emotional needs at different ages and their capacity to be emotionally available to their children.

Detailed description: Mothers who are physically and/or psychologically dependent upon alcohol and drugs are at risk for a wide range of parenting deficits beginning when their children are infants and continuing as their children move through school-age and adolescent years. Behavioral parent training programs for drug dependent mothers have had limited success in improving mother-child relationships or children's psychosocial adjustment. One reason behavioral parenting programs may have had limited success is the lack of attention to emotional aspects of the mother-child relationship, including (1) mothers' recognition of their children's emotional needs and (2) mothers' capacity to respond sensitively to their children's emotional cues. Research on attachment suggests that the emotional quality of the early mother-child relationship has important implications for many developmental capacities, including emotional and behavior regulation in early years, and social competence academic achievement in school-aged and adolescent years. In this Stage I therapy development study, we propose to modify a previously piloted attachment-based group parenting intervention called Emotionally-Responsive Parenting Group or ERP. The goal of the intervention is to improve the mother's capacity to recognize and sensitively respond to her child's emotional cues. In a pre-pilot study (see Preliminary Study 6) we tested the feasibility of conducting the ERP group intervention as an adjunct group treatment for 23 primarily cocaine-dependent mothers in outpatient drug treatment and found that ERP was highly feasible and showed initial promise for improving maternal recognition of emotional cues. In this study, we aim to modify and validate the intervention as an individual therapy for drug dependent mothers of children ages 18 to 36 months in preparation for a Stage II controlled efficacy trial.

More specifically, we will:

1. Develop and modify a 12-session ERP individual therapy for drug dependent mothers enrolled in outpatient drug treatment have custody of a child between 18 and 36 months of age. Fifteen mothers enrolled in outpatient drug treatment will participate in this phase of the ERP manual's development.
2. Develop and implement a therapist training and supervision program for delivery of the ERP manualized treatment. This phase will include the development of ERP adherence and competence rating scales.
3. Conduct a randomized, controlled pilot study to determine the potential feasibility, acceptability, and efficacy of ERP compared with, Parent Education (PE), a 12-week comparison condition in which mothers will attend 12 1-hour parent education sessions conducted by a paraprofessional. Sixty mothers enrolled in outpatient drug treatment who have at least one child between the ages of 18 and 36 months in their custody will participate. Because the intervention will directly target change in maternal psychological representations of parenting, primary outcomes will be (a) maternal 'reflective functioning' (capacity to make inferences about emotional cues, (b) capacity for balanced psychological representations of the child, and (c) knowledge of the child's developmental capacities. The intervention will indirectly target maternal and child behavior and maternal psychosocial adjustment. Secondary outcomes will be: maternal sensitivity to her child's emotional cues, the child's use of the mother as a secure base, and maternal psychiatric distress, daily functioning and substance abuse.
4. Explore the impact of process variables on outcomes, and potential mediator and moderator effects.. Process variables will be: (a) attendance, (b) therapeutic alliance, (c) therapist adherence and competence and (d) use of additional treatment services.

Eligibility criteria: Inclusion Criteria:

* English-speaking adult women
* history of primary alcohol, cocaine, cannabis, club drug, or heroin abuse or dependence
* caring for a child between 1 and 36 months of age

Exclusion criteria:

* acute suicidality/ homicidality
* severe psychiatric or substance-related symptoms requiring in-patient hospitalization or ambulatory detoxification

Primary outcomes:
measure: Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)
timeFrame: post-treatment and 6-week follow up
measure: Quality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)
timeFrame: post-treatment, 6-week follow up
Secondary outcomes:
measure: Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)
timeFrame: post-treatment, 6-week follow up
measure: Child Behavior (Assessed With the NCAST Teaching Scales)
timeFrame: post-treatment and 6-wk follow up
measure: Maternal Depression (Measured With the Beck Depression Inventory)
timeFrame: post-treatment and 6-wk follow up
measure: Maternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)
timeFrame: post-treatment and 6-wk follow up
measure: Maternal Substance Abuse (Assessed With Urine Toxicology Screens)
timeFrame: post-treatment and 6-wk follow up
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The APT Foundation
state: Connecticut
Study officials:
affiliation: Yale University
name: Nancy E Suchman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suchman N, Mayes L, Conti J, Slade A, Rounsaville B. Rethinking parenting interventions for drug-dependent mothers: from behavior management to fostering emotional bonds. J Subst Abuse Treat. 2004 Oct;27(3):179-85. doi: 10.1016/j.jsat.2004.06.008.
citation: Suchman N, Pajulo M, Decoste C, Mayes L. Parenting Interventions for Drug-Dependent Mothers and Their Young Children: The Case for an Attachment-Based Approach. Fam Relat. 2006 Apr;55(2):211-226. doi: 10.1111/j.1741-3729.2006.00371.x.
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, 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.
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, 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 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.