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

Fostering Mothers' Emotionally Responsive Parenting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00319436
Enrollment
47
Registered
2006-04-27
Start date
2004-08-31
Completion date
2009-03-31
Last updated
2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Abuse and Neglect, Maternal Substance Use

Keywords

parenting intervention, family intervention, maternal substance abuse, mother-child relations, parent-child relations

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.

Interventions

BEHAVIORALMentalizing 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.

BEHAVIORALStandard 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)post-treatment and 6-week follow upThe 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.
Quality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)post-treatment, 6-week follow upThe 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.

Secondary

MeasureTime frameDescription
Maternal Depression (Measured With the Beck Depression Inventory)post-treatment and 6-wk follow upThe 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).
Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)post-treatment, 6-week follow upMothers 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).
Maternal Substance Abuse (Assessed With Urine Toxicology Screens)post-treatment and 6-wk follow upMaternal 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.
Maternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)post-treatment and 6-wk follow upThe 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.
Child Behavior (Assessed With the NCAST Teaching Scales)post-treatment and 6-wk follow upChild 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).

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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.
23
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.
24
Total47

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject67

Baseline characteristics

CharacteristicMentalizing Therapy for MothersStandard Parent EducationTotal
Age, Continuous31.43 years
STANDARD_DEVIATION 6.46
28.88 years
STANDARD_DEVIATION 6.5
30.16 years
STANDARD_DEVIATION 6.48
Region of Enrollment
United States
23 participants24 participants47 participants
Sex: Female, Male
Female
23 Participants24 Participants47 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 230 / 24
serious
Total, serious adverse events
0 / 230 / 24

Outcome results

Primary

Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)

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.

Time frame: post-treatment and 6-week follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Mentalizing Therapy for MothersMaternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)Mentalizing for Self at 6-week follow up3.47 units on a scaleStandard Deviation 0.59
Mentalizing Therapy for MothersMaternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)Mentalizing about Child at 6-week follow up3.45 units on a scaleStandard Deviation 0.39
Mentalizing Therapy for MothersMaternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)Mentalizing about Child at post-treatment3.54 units on a scaleStandard Deviation 0.54
Mentalizing Therapy for MothersMaternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)Mentalizing for Self at post-treatment3.59 units on a scaleStandard Deviation 0.65
Standard Parent EducationMaternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)Mentalizing about Child at 6-week follow up3.37 units on a scaleStandard Deviation 0.39
Standard Parent EducationMaternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)Mentalizing for Self at post-treatment3.08 units on a scaleStandard Deviation 0.65
Standard Parent EducationMaternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)Mentalizing about Child at post-treatment3.47 units on a scaleStandard Deviation 0.54
Standard Parent EducationMaternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)Mentalizing for Self at 6-week follow up3.09 units on a scaleStandard Deviation 0.59
Primary

Quality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)

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.

Time frame: post-treatment, 6-week follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Mentalizing Therapy for MothersQuality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)Maternal Representations at post-treatment2.86 units on a scaleStandard Deviation 0.4
Mentalizing Therapy for MothersQuality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)Maternal Representations at 6-wk follow up2.86 units on a scaleStandard Deviation 0.32
Standard Parent EducationQuality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)Maternal Representations at post-treatment2.78 units on a scaleStandard Deviation 0.4
Standard Parent EducationQuality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)Maternal Representations at 6-wk follow up2.71 units on a scaleStandard Deviation 0.32
Secondary

Child Behavior (Assessed With the NCAST Teaching Scales)

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).

Time frame: post-treatment and 6-wk follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Mentalizing Therapy for MothersChild Behavior (Assessed With the NCAST Teaching Scales)Child Contingency Score at post-treatment9.47 units on a scaleStandard Deviation 1.57
Mentalizing Therapy for MothersChild Behavior (Assessed With the NCAST Teaching Scales)Child Contingency Score at 6-wk follow up9.61 units on a scaleStandard Deviation 1.48
Mentalizing Therapy for MothersChild Behavior (Assessed With the NCAST Teaching Scales)Child Total Score at 6-wk follow up20.16 units on a scaleStandard Deviation 2.12
Mentalizing Therapy for MothersChild Behavior (Assessed With the NCAST Teaching Scales)Child Total Score at post-treatment19.74 units on a scaleStandard Deviation 2.44
Standard Parent EducationChild Behavior (Assessed With the NCAST Teaching Scales)Child Contingency Score at post-treatment9.16 units on a scaleStandard Deviation 1.56
Standard Parent EducationChild Behavior (Assessed With the NCAST Teaching Scales)Child Total Score at post-treatment18.78 units on a scaleStandard Deviation 2.43
Standard Parent EducationChild Behavior (Assessed With the NCAST Teaching Scales)Child Total Score at 6-wk follow up18.66 units on a scaleStandard Deviation 2.12
Standard Parent EducationChild Behavior (Assessed With the NCAST Teaching Scales)Child Contingency Score at 6-wk follow up9.11 units on a scaleStandard Deviation 1.47
Secondary

Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)

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).

Time frame: post-treatment, 6-week follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Mentalizing Therapy for MothersMaternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)Total Caregiver Score at post-treatment37.79 units on a scaleStandard Deviation 3.45
Mentalizing Therapy for MothersMaternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)Total Caregiver Score at 6-wk follow up37.06 units on a scaleStandard Deviation 3.39
Mentalizing Therapy for MothersMaternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)Total Caregiver Contingency Score at 6-wk follow u13.62 units on a scaleStandard Deviation 1.73
Mentalizing Therapy for MothersMaternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)Total Caregiver Contingency Score at post-treatmen14.60 units on a scaleStandard Deviation 1.93
Standard Parent EducationMaternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)Total Caregiver Score at 6-wk follow up34.61 units on a scaleStandard Deviation 3.38
Standard Parent EducationMaternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)Total Caregiver Score at post-treatment35.75 units on a scaleStandard Deviation 3.44
Standard Parent EducationMaternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)Total Caregiver Contingency Score at post-treatmen13.01 units on a scaleStandard Deviation 1.93
Standard Parent EducationMaternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)Total Caregiver Contingency Score at 6-wk follow u12.14 units on a scaleStandard Deviation 1.73
Secondary

Maternal Depression (Measured With the Beck Depression Inventory)

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).

Time frame: post-treatment and 6-wk follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Mentalizing Therapy for MothersMaternal Depression (Measured With the Beck Depression Inventory)Maternal Depression at post-treatment13.57 units on a scaleStandard Deviation 7.3
Mentalizing Therapy for MothersMaternal Depression (Measured With the Beck Depression Inventory)Maternal Depression at 6-wk follow up14.37 units on a scaleStandard Deviation 6.66
Standard Parent EducationMaternal Depression (Measured With the Beck Depression Inventory)Maternal Depression at post-treatment16.01 units on a scaleStandard Deviation 7.28
Standard Parent EducationMaternal Depression (Measured With the Beck Depression Inventory)Maternal Depression at 6-wk follow up12.14 units on a scaleStandard Deviation 6.65
Secondary

Maternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)

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.

Time frame: post-treatment and 6-wk follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Mentalizing Therapy for MothersMaternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)Maternal Psychiatric Distress at post-treatment58.86 units on a scaleStandard Deviation 6.71
Mentalizing Therapy for MothersMaternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)Maternal Psychiatric Distress at 6-wk follow up58.41 units on a scaleStandard Deviation 6.71
Standard Parent EducationMaternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)Maternal Psychiatric Distress at post-treatment60.24 units on a scaleStandard Deviation 6.71
Standard Parent EducationMaternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)Maternal Psychiatric Distress at 6-wk follow up58.29 units on a scaleStandard Deviation 6.71
Secondary

Maternal Substance Abuse (Assessed With Urine Toxicology Screens)

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.

Time frame: post-treatment and 6-wk follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Mentalizing Therapy for MothersMaternal Substance Abuse (Assessed With Urine Toxicology Screens)Maternal Substance use at post-treatment20 % positive utox screens/monthStandard Error 0.36
Mentalizing Therapy for MothersMaternal Substance Abuse (Assessed With Urine Toxicology Screens)Maternal Substance use at 6-wk follow up7 % positive utox screens/monthStandard Error 0.22
Standard Parent EducationMaternal Substance Abuse (Assessed With Urine Toxicology Screens)Maternal Substance use at post-treatment22 % positive utox screens/monthStandard Error 0.36
Standard Parent EducationMaternal Substance Abuse (Assessed With Urine Toxicology Screens)Maternal Substance use at 6-wk follow up6 % positive utox screens/monthStandard Error 0.22

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026