Trial Outcomes & Findings for Stage I Randomized Trial of Mentalization-Based Therapy for Substance Using Mothers of Infants and Toddlers (NCT NCT00319436)
NCT ID: NCT00319436
Last Updated: 2020-04-09
Results Overview
The Parent Development Interview (PDI) 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.
COMPLETED
NA
47 participants
post-treatment and 6-week follow up
2020-04-09
Participant Flow
All mothers enrolled in outpatient substance use treatment and caring for a child between birth and 36 months of age were eligible. Mothers were recruited via clinician referrals and self-referral. Mothers who were actively suicidal, homicidal, severely cognitively impaired, disengaged from their treatment or not fluent in English were excluded.
Mothers were informed that after completing a baseline assessment they would be randomly assigned to one of two parenting programs. Mothers were asked permission to access their clinic attendance records and urinary toxicity results over the course of the study.
Participant milestones
| Measure |
Mentalizing Therapy for 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.
|
Standard Parent Education
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.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Mentalizing Therapy for 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.
|
Standard Parent Education
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.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
Baseline Characteristics
Stage I Randomized Trial of Mentalization-Based Therapy for Substance Using Mothers of Infants and Toddlers
Baseline characteristics by cohort
| Measure |
Mentalizing Therapy for Mothers
n=23 Participants
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
n=24 Participants
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.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.43 years
STANDARD_DEVIATION 6.46 • n=5 Participants
|
28.88 years
STANDARD_DEVIATION 6.50 • n=7 Participants
|
30.16 years
STANDARD_DEVIATION 6.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: post-treatment and 6-week follow upPopulation: Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.
The Parent Development Interview (PDI) 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.
Outcome measures
| Measure |
Mentalizing Therapy for Mothers
n=23 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)
Mentalizing for Self at post-treatment
|
3.59 units on a scale
Standard Deviation .65
|
3.08 units on a scale
Standard Deviation .65
|
|
Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)
Mentalizing about Child at post-treatment
|
3.54 units on a scale
Standard Deviation .54
|
3.47 units on a scale
Standard Deviation .54
|
|
Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)
Mentalizing for Self at 6-week follow up
|
3.47 units on a scale
Standard Deviation .59
|
3.09 units on a scale
Standard Deviation .59
|
|
Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)
Mentalizing about Child at 6-week follow up
|
3.45 units on a scale
Standard Deviation .39
|
3.37 units on a scale
Standard Deviation .39
|
PRIMARY outcome
Timeframe: post-treatment, 6-week follow upPopulation: Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.
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 to reliably code 6 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.
Outcome measures
| Measure |
Mentalizing Therapy for Mothers
n=23 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Quality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)
Maternal Representations at post-treatment
|
2.86 units on a scale
Standard Deviation .40
|
2.78 units on a scale
Standard Deviation .40
|
|
Quality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)
Maternal Representations at 6-wk follow up
|
2.86 units on a scale
Standard Deviation .32
|
2.71 units on a scale
Standard Deviation .32
|
SECONDARY outcome
Timeframe: post-treatment, 6-week follow upPopulation: Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.
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 (73 items) with scores ranging from 0 to 73. 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 (scores range from 0 to 20). Higher score are better and lower scores are worse. For mothers with high school education (which a majority in our sample had) here are the normative means (SDs) reported in the scoring manual: Total Caregiver Score = 40.69 (6.85), Sensitivity to Cues = 9.16 (1.62), Response to Distress = 10.04 (1.78), Social-Emotional Growth = 8.99 (1.83), Cognitive Growth = 12.51 (3).
Outcome measures
| Measure |
Mentalizing Therapy for Mothers
n=23 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)
Total Caregiver Score at post-treatment
|
37.79 units on a scale
Standard Deviation 3.45
|
35.75 units on a scale
Standard Deviation 3.44
|
|
Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)
Total Caregiver Contingency Score at post-treatmen
|
14.60 units on a scale
Standard Deviation 1.93
|
13.01 units on a scale
Standard Deviation 1.93
|
|
Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)
Total Caregiver Score at 6-wk follow up
|
37.06 units on a scale
Standard Deviation 3.39
|
34.61 units on a scale
Standard Deviation 3.38
|
|
Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)
Total Caregiver Contingency Score at 6-wk follow u
|
13.62 units on a scale
Standard Deviation 1.73
|
12.14 units on a scale
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: post-treatment and 6-wk follow upPopulation: Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.
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 (23 items) with scores ranging from 0 to 23. The Child Contingency Score is the sum of 12 contingent items from the 2 scales (with scores ranging from 0 - 12). The 2 subscores are summed to arrive at the composite score. Higher scores are better. The normative means for the children of high school educated mothers reported in the scoring manual: Total Child Score = 15.44 (4.29), Clarity of Cues = 7.99 (1.49), Responsiveness to Parent = 7.45 (3.16).
Outcome measures
| Measure |
Mentalizing Therapy for Mothers
n=23 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Child Behavior (Assessed With the NCAST Teaching Scales)
Child Total Score at post-treatment
|
19.74 units on a scale
Standard Deviation 2.44
|
18.78 units on a scale
Standard Deviation 2.43
|
|
Child Behavior (Assessed With the NCAST Teaching Scales)
Child Contingency Score at post-treatment
|
9.47 units on a scale
Standard Deviation 1.57
|
9.16 units on a scale
Standard Deviation 1.56
|
|
Child Behavior (Assessed With the NCAST Teaching Scales)
Child Total Score at 6-wk follow up
|
20.16 units on a scale
Standard Deviation 2.12
|
18.66 units on a scale
Standard Deviation 2.12
|
|
Child Behavior (Assessed With the NCAST Teaching Scales)
Child Contingency Score at 6-wk follow up
|
9.61 units on a scale
Standard Deviation 1.48
|
9.11 units on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: post-treatment and 6-wk follow upPopulation: Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.
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).
Outcome measures
| Measure |
Mentalizing Therapy for Mothers
n=23 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Maternal Depression (Measured With the Beck Depression Inventory)
Maternal Depression at 6-wk follow up
|
14.37 units on a scale
Standard Deviation 6.66
|
12.14 units on a scale
Standard Deviation 6.65
|
|
Maternal Depression (Measured With the Beck Depression Inventory)
Maternal Depression at post-treatment
|
13.57 units on a scale
Standard Deviation 7.30
|
16.01 units on a scale
Standard Deviation 7.28
|
SECONDARY outcome
Timeframe: post-treatment and 6-wk follow upPopulation: Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.
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 validityT-scores have a mean of 50 and a standard deviation of 10. Scores within one standard deviation (ie. a T-score of 10) above the mean on any dimension are regarded as being within the normal range on that dimension (Derogatis, 1993). These scores were converted to T-scores using data from the scoring manual. The higher the scores are worse.T scores above 60 on the GSI indicate risk for a clinical disorder.
Outcome measures
| Measure |
Mentalizing Therapy for Mothers
n=23 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Maternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)
Maternal Psychiatric Distress at post-treatment
|
58.86 units on a scale
Standard Deviation 6.71
|
60.24 units on a scale
Standard Deviation 6.71
|
|
Maternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)
Maternal Psychiatric Distress at 6-wk follow up
|
58.41 units on a scale
Standard Deviation 6.71
|
58.29 units on a scale
Standard Deviation 6.71
|
SECONDARY outcome
Timeframe: post-treatment and 6-wk follow upPopulation: Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.
Maternal substance use was monitored weekly using results from weekly urine toxicology (UTOX) screens testing for presence of opiate, cocaine, and cannabis metabolites in urine samples collected at the outpatient clinic. For each month of the mother's participation in the study, a mother received a score of "0" if no drug metabolites were present in any of her urine toxicology screens during that month or a score of "1" if one or more of her urine toxicology screens tested positive for a drug metabolite during that month. A percentage was calculated by= number of positive substance tests/number of total test \*100 for each patients during each month.
Outcome measures
| Measure |
Mentalizing Therapy for Mothers
n=23 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Maternal Substance Abuse (Assessed With Urine Toxicology Screens)
Maternal Substance use at post-treatment
|
20 % positive utox screens/month
Standard Error .36
|
22 % positive utox screens/month
Standard Error .36
|
|
Maternal Substance Abuse (Assessed With Urine Toxicology Screens)
Maternal Substance use at 6-wk follow up
|
7 % positive utox screens/month
Standard Error .22
|
6 % positive utox screens/month
Standard Error .22
|
Adverse Events
Mentalizing Therapy for Mothers
Standard Parent Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nancy Suchman, Ph.D., Associate Professor
Yale University School of Medicine, Department of Psychiatry and Yale Child Study Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place