Back to resultsProgram for Caregivers Involved With Mental Health Services
Primary Purpose
Mental Illness
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mentalization based therapy
Sponsored by
About this trial
This is an interventional treatment trial for Mental Illness focused on measuring Parenting, Mental Illness, Maternal sensitivity, Parent-child relationship
Eligibility Criteria
Inclusion Criteria:
- receive psychiatric services through the adult or young adult treatment team at the West Haven Mental Health Clinic
- have a child receiving psychiatric services through the child treatment team at the West Haven Mental Health Clinic
- express interest in receiving a parent intervention at the West Haven Mental Health Clinic
Exclusion Criteria:
- severe mental health problems (e.g., suicidal, homicidal, psychosis, thought disorder)
- severely cognitively impaired
- have psychiatric or substance-related symptoms requiring inpatient hospitalization or ambulatory detoxification
- are not fluent in English
- child has a serious illness or significant developmental delay (e.g., cognitive, language, or motor)
Sites / Locations
- West Haven Mental Health Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mentalization based therapy
Arm Description
Women who are the primary caregivers of a child between the ages of 0-7 years and are involved with mental health services for themselves or a child.
Outcomes
Primary Outcome Measures
Maternal reflective functioning
PDI: Rated on a -1 to +9 scale where a score of 3 indicates simple awareness of mental states, 5 indicates rudimentary recognition of how mental states influence behavior, and above 5 indicates advance rPRFQ-1: Rated on a 7-point scale. 3 subscales: PMM (Pre-mentalizing Mode) with high scores indicating reliance on pre-reflective modes of thinking about child's behavior, NRO (Not Recognizing Opacity) with high scores indicating less recognition of the opaque nature of the child's mental states, and IC (Interest and Curiosity) with high scores indicating more interest and curiosity about the child's underlying mental states.
Maternal reflective functioning
PDI: Rated on a -1 to +9 scale where a score of 3 indicates simple awareness of mental states, 5 indicates rudimentary recognition of how mental states influence behavior, and above 5 indicates advance rPRFQ-1: Rated on a 7-point scale. 3 subscales: PMM (Pre-mentalizing Mode) with high scores indicating reliance on pre-reflective modes of thinking about child's behavior, NRO (Not Recognizing Opacity) with high scores indicating less recognition of the opaque nature of the child's mental states, and IC (Interest and Curiosity) with high scores indicating more interest and curiosity about the child's underlying mental states.
Secondary Outcome Measures
Coding Interactive Behavior
The caregiver-child dyad will be given age-appropriate toys and instructed to interact freely and session is videotaped and coded using CIB. Composite scores are scored on a 1 - 5 scale. Composite maternal scales include Sensitivity, Intrusiveness, Limit Setting, and Negative Emotion. Composite Child Scales include Child Involvement, Withdrawal and Compliance. Composite Dyadic Scales include Reciprocity and Dyadic Negative States.
Coding Interactive Behavior
The caregiver-child dyad will be given age-appropriate toys and instructed to interact freely and session is videotaped and coded using CIB. Composite scores are scored on a 1 - 5 scale. Composite maternal scales include Sensitivity, Intrusiveness, Limit Setting, and Negative Emotion. Composite Child Scales include Child Involvement, Withdrawal and Compliance. Composite Dyadic Scales include Reciprocity and Dyadic Negative States.
Maternal parenting stress
The PSI yields five scores: Parent Dysfunction, Parent-Child Difficulty, Difficult Child, Defensive Responding, and Total Stress which are standardized to percentile rankings. We will be testing for reduction in each stress domain to below the 85th percentile.
Maternal parenting stress
The PSI yields five scores: Parent Dysfunction, Parent-Child Difficulty, Difficult Child, Defensive Responding, and Total Stress which are standardized to percentile rankings. We will be testing for reduction in each stress domain to below the 85th percentile.
Maternal depression
Scores range from 0 to 63. We will be testing for significant reduction in total depression.
Maternal depression
Scores range from 0 to 63. We will be testing for significant reduction in total depression.
Maternal global psychiatric distress
The composite Global Severity Index (GSI) from the Brief Symptom Inventory measures current overall symptomatology across multiple domains (e.g., depression, anxiety, interpersonal sensitivity, somatic complaints, paranoid ideation) and has demonstrated good reliability and validity. T scores above 60 on the GSI indicate risk for a clinical disorder.
Maternal global psychiatric distress
The composite Global Severity Index (GSI) from the Brief Symptom Inventory measures current overall symptomatology across multiple domains (e.g., depression, anxiety, interpersonal sensitivity, somatic complaints, paranoid ideation) and has demonstrated good reliability and validity. T scores above 60 on the GSI indicate risk for a clinical disorder.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01872585
Brief Title
Program for Caregivers Involved With Mental Health Services
Official Title
Feasibility Study of a Mentalization-based Parenting Program for Female Caregivers Involved in Mental Health Services.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this two-year pilot study is to adapt a 12-week attachment-based parenting intervention for implementation with female adult caregivers who have or are at risk for long-term interpersonal conflict with family members, children, or significant others and are caring for a child between the ages of birth and 7 years.
Detailed Description
The purpose of this two-year pilot study is to adapt a 12-week attachment-based parenting intervention (Parenting from the Inside Out or PIO) originally developed for substance abusing mothers (as part of an ongoing NIDA-funded treatment development study; R01 DA17294) for implementation with female adult caregivers who have or are at risk for long-term interpersonal conflict with family members, children, or significant others and are caring for a child between the ages of birth and 7 years. The PIO intervention involves 12-24 weekly 1 hour individual therapy sessions with Masters level therapists who are trained and supervised by Dr. Suchman (the Principal Investigator) in the PIO approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness
Keywords
Parenting, Mental Illness, Maternal sensitivity, Parent-child relationship
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mentalization based therapy
Arm Type
Experimental
Arm Description
Women who are the primary caregivers of a child between the ages of 0-7 years and are involved with mental health services for themselves or a child.
Intervention Type
Behavioral
Intervention Name(s)
Mentalization based therapy
Intervention Description
12-24 weekly 1 hour individual therapy sessions with Masters level therapists who are trained and supervised by Dr. Suchman (the Principal Investigator) in the Parenting from the Inside Out approach. The broad goals of the program are to help prevent the onset of substance abuse and psychiatric disorders, promote adaptive interpersonal relationships and social-emotional functioning in caregivers and their children, and help prevent the transmission of psychiatric illness across generations
Primary Outcome Measure Information:
Title
Maternal reflective functioning
Description
PDI: Rated on a -1 to +9 scale where a score of 3 indicates simple awareness of mental states, 5 indicates rudimentary recognition of how mental states influence behavior, and above 5 indicates advance rPRFQ-1: Rated on a 7-point scale. 3 subscales: PMM (Pre-mentalizing Mode) with high scores indicating reliance on pre-reflective modes of thinking about child's behavior, NRO (Not Recognizing Opacity) with high scores indicating less recognition of the opaque nature of the child's mental states, and IC (Interest and Curiosity) with high scores indicating more interest and curiosity about the child's underlying mental states.
Time Frame
Change at week 12 from baseline
Title
Maternal reflective functioning
Description
PDI: Rated on a -1 to +9 scale where a score of 3 indicates simple awareness of mental states, 5 indicates rudimentary recognition of how mental states influence behavior, and above 5 indicates advance rPRFQ-1: Rated on a 7-point scale. 3 subscales: PMM (Pre-mentalizing Mode) with high scores indicating reliance on pre-reflective modes of thinking about child's behavior, NRO (Not Recognizing Opacity) with high scores indicating less recognition of the opaque nature of the child's mental states, and IC (Interest and Curiosity) with high scores indicating more interest and curiosity about the child's underlying mental states.
Time Frame
Change at week 24 from baseline
Secondary Outcome Measure Information:
Title
Coding Interactive Behavior
Description
The caregiver-child dyad will be given age-appropriate toys and instructed to interact freely and session is videotaped and coded using CIB. Composite scores are scored on a 1 - 5 scale. Composite maternal scales include Sensitivity, Intrusiveness, Limit Setting, and Negative Emotion. Composite Child Scales include Child Involvement, Withdrawal and Compliance. Composite Dyadic Scales include Reciprocity and Dyadic Negative States.
Time Frame
Change at week 12 from baseline
Title
Coding Interactive Behavior
Description
The caregiver-child dyad will be given age-appropriate toys and instructed to interact freely and session is videotaped and coded using CIB. Composite scores are scored on a 1 - 5 scale. Composite maternal scales include Sensitivity, Intrusiveness, Limit Setting, and Negative Emotion. Composite Child Scales include Child Involvement, Withdrawal and Compliance. Composite Dyadic Scales include Reciprocity and Dyadic Negative States.
Time Frame
Change at week 24 from baseline
Title
Maternal parenting stress
Description
The PSI yields five scores: Parent Dysfunction, Parent-Child Difficulty, Difficult Child, Defensive Responding, and Total Stress which are standardized to percentile rankings. We will be testing for reduction in each stress domain to below the 85th percentile.
Time Frame
Change at week 12 from baseline
Title
Maternal parenting stress
Description
The PSI yields five scores: Parent Dysfunction, Parent-Child Difficulty, Difficult Child, Defensive Responding, and Total Stress which are standardized to percentile rankings. We will be testing for reduction in each stress domain to below the 85th percentile.
Time Frame
Change at week 24 from baseline
Title
Maternal depression
Description
Scores range from 0 to 63. We will be testing for significant reduction in total depression.
Time Frame
Change at week 12 from baseline
Title
Maternal depression
Description
Scores range from 0 to 63. We will be testing for significant reduction in total depression.
Time Frame
Change at week 24 from baseline
Title
Maternal global psychiatric distress
Description
The composite Global Severity Index (GSI) from the Brief Symptom Inventory measures current overall symptomatology across multiple domains (e.g., depression, anxiety, interpersonal sensitivity, somatic complaints, paranoid ideation) and has demonstrated good reliability and validity. T scores above 60 on the GSI indicate risk for a clinical disorder.
Time Frame
Change at week 12 from baseline
Title
Maternal global psychiatric distress
Description
The composite Global Severity Index (GSI) from the Brief Symptom Inventory measures current overall symptomatology across multiple domains (e.g., depression, anxiety, interpersonal sensitivity, somatic complaints, paranoid ideation) and has demonstrated good reliability and validity. T scores above 60 on the GSI indicate risk for a clinical disorder.
Time Frame
Change at week 24 from baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
receive psychiatric services through the adult or young adult treatment team at the West Haven Mental Health Clinic
have a child receiving psychiatric services through the child treatment team at the West Haven Mental Health Clinic
express interest in receiving a parent intervention at the West Haven Mental Health Clinic
Exclusion Criteria:
severe mental health problems (e.g., suicidal, homicidal, psychosis, thought disorder)
severely cognitively impaired
have psychiatric or substance-related symptoms requiring inpatient hospitalization or ambulatory detoxification
are not fluent in English
child has a serious illness or significant developmental delay (e.g., cognitive, language, or motor)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy E Suchman, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Haven Mental Health Clinic
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27575343
Citation
Suchman NE, Ordway MR, de Las Heras L, McMahon TJ. Mothering from the Inside Out: results of a pilot study testing a mentalization-based therapy for mothers enrolled in mental health services. Attach Hum Dev. 2016 Dec;18(6):596-617. doi: 10.1080/14616734.2016.1226371. Epub 2016 Aug 30.
Results Reference
result
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Program for Caregivers Involved With Mental Health Services
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