Program for Caregivers Involved With Mental Health Services

Mental Illness Clinical Trial

Official title:

Feasibility Study of a Mentalization-based Parenting Program for Female Caregivers Involved in Mental Health Services.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872585
• Other study ID #: 1004006576
• Status: Completed
• Phase: Early Phase 1
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness

Intervention

Behavioral:
• Mentalization based therapy
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

Locations

Country	Name	City	State
United States	West Haven Mental Health Clinic	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2016 Aug 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change at week 12 from baseline
Primary	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.	Change at week 24 from baseline
Secondary	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.	Change at week 12 from baseline
Secondary	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.	Change at week 24 from baseline
Secondary	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.	Change at week 12 from baseline
Secondary	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.	Change at week 24 from baseline
Secondary	Maternal depression	Scores range from 0 to 63. We will be testing for significant reduction in total depression.	Change at week 12 from baseline
Secondary	Maternal depression	Scores range from 0 to 63. We will be testing for significant reduction in total depression.	Change at week 24 from baseline
Secondary	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.	Change at week 12 from baseline
Secondary	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.	Change at week 24 from baseline

External Links

•   Principal Investigator profile and bio