Program for Caregivers Involved With Mental Health Services

This study is currently recruiting participants.
Verified January 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Nancy E. Suchman, Yale University
ClinicalTrials.gov Identifier:
NCT01872585
First received: April 27, 2012
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Mental Illness
Behavioral: Mentalization based therapy
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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 Yale University:

Primary Outcome Measures:
  • Maternal reflective functioning [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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: 12 weeks ] [ Designated as safety issue: No ]
    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: 24 weeks ] [ Designated as safety issue: No ]
    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: Baseline ] [ Designated as safety issue: No ]
    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: Baseline ] [ Designated as safety issue: No ]
    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: Baseline ] [ Designated as safety issue: No ]
    Scores range from 0 to 63. We will be testing for significant reduction in total depression.

  • Maternal global psychiatric distress [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Coding Interactive Behavior [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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: 24 weeks ] [ Designated as safety issue: No ]
    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: 12 weeks ] [ Designated as safety issue: No ]
    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: 24 weeks ] [ Designated as safety issue: No ]
    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: 12 weeks ] [ Designated as safety issue: No ]
    Scores range from 0 to 63. We will be testing for significant reduction in total depression.

  • Maternal depression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Scores range from 0 to 63. We will be testing for significant reduction in total depression.

  • Maternal global psychiatric distress [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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: 24 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: April 2012
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01872585

Contacts
Contact: Thomas McMahon, PhD (203) 974-5950 thomas.mcmahon@yale.edu
Contact: Lourdes de las Heras, MS 203-285-1743 lourdes.delasheras@yale.edu

Locations
United States, Connecticut
West Haven Mental Health Clinic Recruiting
West Haven, Connecticut, United States, 06516
Contact: Thomas McMahon, PhD    203-974-5950    thomas.mcmahon@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Nancy E Suchman, PhD Yale University
  More Information

Additional Information:
No publications provided

Responsible Party: Nancy E. Suchman, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01872585     History of Changes
Other Study ID Numbers: K02 DA023504
Study First Received: April 27, 2012
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Parenting
Mental Illness
Maternal sensitivity
Parent-child relationship

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014