Stage I Randomized Trial of Mentalization-Based Therapy for Substance Using Mothers of Infants and Toddlers
Condition: Maternal Substance Use; Child Abuse and Neglect
MeSH terms: Substance-Related Disorders
Study type: Interventional

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.
    

Intervention name(s): Mentalizing Therapy for Substance Using Mothers; Standard Parent Education for Substance Using Mothers
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: parenting intervention; family intervention; maternal substance abuse; mother-child relations; parent-child relations