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Program for Caregivers Involved With Mental Health Services

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01872585
First Posted: June 7, 2013
Last Update Posted: November 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nancy E. Suchman, Yale University
  Purpose
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.

Condition Intervention Phase
Mental Illness Behavioral: Mentalization based therapy Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of a Mentalization-based Parenting Program for Female Caregivers Involved in Mental Health Services.

Resource links provided by NLM:


Further study details as provided by Nancy E. Suchman, Yale University:

Primary Outcome Measures:
  • Maternal reflective functioning [ Time Frame: Change at week 12 from baseline ]
    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 [ Time Frame: Change at week 24 from baseline ]
    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 [ Time Frame: Change at week 12 from baseline ]
    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 [ Time Frame: Change at week 24 from baseline ]
    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 [ Time Frame: Change at week 12 from baseline ]
    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 [ Time Frame: Change at week 24 from baseline ]
    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 [ Time Frame: Change at week 12 from baseline ]
    Scores range from 0 to 63. We will be testing for significant reduction in total depression.

  • Maternal depression [ Time Frame: Change at week 24 from baseline ]
    Scores range from 0 to 63. We will be testing for significant reduction in total depression.

  • Maternal global psychiatric distress [ Time Frame: Change at week 12 from baseline ]
    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 [ Time Frame: Change at week 24 from baseline ]
    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.


Enrollment: 18
Study Start Date: April 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mentalization based therapy
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.
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01872585


Locations
United States, Connecticut
West Haven Mental Health Clinic
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Nancy E Suchman, PhD Yale University
  More Information

Additional Information:
Publications:
Responsible Party: Nancy E. Suchman, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01872585     History of Changes
Other Study ID Numbers: K02DA023504 ( U.S. NIH Grant/Contract )
First Submitted: April 27, 2012
First Posted: June 7, 2013
Last Update Posted: November 8, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nancy E. Suchman, Yale University:
Parenting
Mental Illness
Maternal sensitivity
Parent-child relationship

Additional relevant MeSH terms:
Mental Disorders