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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Maternal Substance Use Child Abuse and Neglect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mentalizing Therapy for Substance Using 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.

Group Type EXPERIMENTAL

Mentalizing Therapy for Substance Using Mothers

Intervention Type BEHAVIORAL

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 for Substance Using Mothers

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.

Group Type ACTIVE_COMPARATOR

Standard Parent Education for Substance Using Mothers

Intervention Type BEHAVIORAL

This 12 session comparison was designed to match the experimental intervention 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 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.

Interventions

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Mentalizing Therapy for Substance Using 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.

Intervention Type BEHAVIORAL

Standard Parent Education for Substance Using Mothers

This 12 session comparison was designed to match the experimental intervention 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 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No