Trial of Mentalization-Based Therapy for Substance Using Mothers of Infants and Toddlers
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ClinicalTrials.gov Identifier: NCT01240993 |
Recruitment Status :
Completed
First Posted : November 15, 2010
Last Update Posted : April 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Parenting Capacities of Substance Abusing Mothers | Behavioral: Mothers and Toddlers Program Behavioral: Parent Education | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Fostering Mothers' Emotionally-Responsive Parenting |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | September 2015 |
Arm | Intervention/treatment |
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Active Comparator: Parent Education
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.
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Behavioral: Parent Education
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. |
Experimental: Mothers and Toddlers Program
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.
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Behavioral: Mothers and Toddlers Program
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. |
- Parent Development Interview coded for maternal reflective functioning [ Time Frame: Change at week 12 (post-treatment) from baseline ]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.
- Parent Development Interview coded for maternal reflective functioning [ Time Frame: Change at week 33 (follow up) from baseline ]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.
- Working Model of the Child Interview (coded for representation quality) [ Time Frame: Change at week 12 (post-treatment) from baseline ]The Working Model of the Child Interview (WMCI; Zeanah & Benoit, 1993) is a 1.5 hour interview used to elicit a narrative description of the mother's perceptions of her child and their relationship. The rater was trained by the to reliably code 6e qualitative subscales Openness, Richness, Coherence, Caregiving Sensitivity and Acceptance and Involvement. On the mean of six subscales, a score of three is considered to represent average representational quality, scores of 1 and 2 are considered to represent clinical risk and scores of 4 and 5 are considered to represent optimal quality.
- Working Model of the Child Interview (coded for representation quality) [ Time Frame: Change at week 33 (follow up) from baseline ]The Working Model of the Child Interview (WMCI; Zeanah & Benoit, 1993) is a 1.5 hour interview used to elicit a narrative description of the mother's perceptions of her child and their relationship. The rater was trained by the to reliably code 6e qualitative subscales Openness, Richness, Coherence, Caregiving Sensitivity and Acceptance and Involvement. On the mean of six subscales, a score of three is considered to represent average representational quality, scores of 1 and 2 are considered to represent clinical risk and scores of 4 and 5 are considered to represent optimal quality.
- NCAST Teaching Scales (Maternal Behavior) [ Time Frame: Change at week 12 (post-treatment) from baseline ]The NCAST Teaching Scale (Barnard & Eyres, 1979) is a standardized, 73 item tool used to observe and rate quality of interactions with children birth to 36 months. Mothers choose a task to teach the child in a 5 minute teaching session. Maternal behavior is coded on 4 dimensions: Sensitivity to Cues, Response to Distress, Social-Emotional Growth Fostering, & Cognitive Growth Fostering. The Total Caregiver Score is the sum of the 4 subscale scores. The Total Caregiver Contingency Score is the sum of 20 items from the 4 subscales that involve the caregiver's contingent response to child cues.
- NCAST Teaching Scales (Maternal Behavior) [ Time Frame: Change at week 33 (follow up) from baseline ]The NCAST Teaching Scale (Barnard & Eyres, 1979) is a standardized, 73 item tool used to observe and rate quality of interactions with children birth to 36 months. Mothers choose a task to teach the child in a 5 minute teaching session. Maternal behavior is coded on 4 dimensions: Sensitivity to Cues, Response to Distress, Social-Emotional Growth Fostering, & Cognitive Growth Fostering. The Total Caregiver Score is the sum of the 4 subscale scores. The Total Caregiver Contingency Score is the sum of 20 items from the 4 subscales that involve the caregiver's contingent response to child cues.
- NCAST Teaching Scales (Child Behavior) [ Time Frame: Change at week 12 (post-treatment) from baseline ]Child behavior with the mother was assessed using the Clarity of Cues and the Responsiveness to Caregiver Subscales from the NCAST Teaching Scales. The Child Total Score is the sum of the 2 scales. The Child Contingency Score is the sum of 12 contingent items from the 2 scales.
- NCAST Teaching Scales (Child Behavior) [ Time Frame: Change at week 33 (follow up) from baseline ]Child behavior with the mother was assessed using the Clarity of Cues and the Responsiveness to Caregiver Subscales from the NCAST Teaching Scales. The Child Total Score is the sum of the 2 scales. The Child Contingency Score is the sum of 12 contingent items from the 2 scales.
- Child Attachment Status [ Time Frame: Change at week 12 (post-treatment) from baseline ]We will use the standard 8-episode protocol Strange Situation protocol. Each child will receive a classification of secure, insecure or disorganized for each time point.
- Beck Depression Inventory [ Time Frame: Change at week 12 (post-treatment) from baseline ]The Beck Depression Inventory (BDI; Beck, Steer, & Brown, 1996) was used to assess maternal symptoms of depression. The BDI is a widely used 21-item questionnaire rated on a 4-point scale and yields a total score ranging from 0 to 63: scores between 13 and 19 indicate mild depression; scores between 20 and 28 indicate moderate levels of depression, and scores between 29 and 63 indicate severe levels of depression (Beck et al., 1996).
- Beck Depression Inventory [ Time Frame: Change at week 33 (follow up) from baseline ]The Beck Depression Inventory (BDI; Beck, Steer, & Brown, 1996) was used to assess maternal symptoms of depression. The BDI is a widely used 21-item questionnaire rated on a 4-point scale and yields a total score ranging from 0 to 63: scores between 13 and 19 indicate mild depression; scores between 20 and 28 indicate moderate levels of depression, and scores between 29 and 63 indicate severe levels of depression (Beck et al., 1996).
- Brief Symptom Inventory [ Time Frame: Change at week 33 (follow up) from baseline ]The Brief Symptom Inventory (BSI; Derogatis, 1993) was used to assess maternal global psychiatric distress. The BSI is a standardized, widely used, 53-item, 5-point, self-report measure of psychopathology. The composite Global Severity Index (GSI) measures current overall symptomatology across multiple domains and has demonstrated good reliability and validity (Derogatis, 1993). T scores above 60 on the GSI indicate risk for a clinical disorder.
- Curiosity Box Paradigm [ Time Frame: Change at week 12 (post-treatment) from baseline ]. We will use the Curiosity Box Paradigm (Mayes et al., 1993) to assess dyadic adjustment under circumstances of mild uncertainty (i.e., during the child's exploration of unfamiliar toys/objects). Children will explore a box of 9 novel toys or objects (that they are unlikely to have seen before) after an initial 5 minute warm up period with one box of 9 familiar toys. Maternal, child and dyadic behavior will be assessed with the Coding Interaction Behavior Scales (Feldman, 1998).
- Curiosity Box Paradigm [ Time Frame: Change at week 33 (follow up) from baseline ]. We will use the Curiosity Box Paradigm (Mayes et al., 1993) to assess dyadic adjustment under circumstances of mild uncertainty (i.e., during the child's exploration of unfamiliar toys/objects). Children will explore a box of 9 novel toys or objects (that they are unlikely to have seen before) after an initial 5 minute warm up period with one box of 9 familiar toys. Maternal, child and dyadic behavior will be assessed with the Coding Interaction Behavior Scales (Feldman, 1998).

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Ages Eligible for Study: | 21 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240993
United States, Connecticut | |
The Moms 'n' Kids Program at the APT Foundation | |
New Haven, Connecticut, United States, 06511 | |
Yale Psychosocial Substance Abuse Research Unit | |
West Haven, Connecticut, United States, 06516 |
Principal Investigator: | Nancy E. Suchman, Ph.D. | Yale University School of Medicine, Department of Psychiatry |
Other Publications:
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01240993 |
Other Study ID Numbers: |
0407026890-C |
First Posted: | November 15, 2010 Key Record Dates |
Last Update Posted: | April 2, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
parenting intervention mother-child relations substance abuse attachment child development |