Program for Caregivers Involved With Mental Health Services

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT01872585
Collaborator
(none)
18
1
1
26
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mentalization based therapy
Early Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
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.
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Maternal reflective functioning [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.

  2. Maternal reflective functioning [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

  1. Coding Interactive Behavior [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.

  2. Coding Interactive Behavior [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.

  3. Maternal parenting stress [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.

  4. Maternal parenting stress [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.

  5. Maternal depression [Change at week 12 from baseline]

    Scores range from 0 to 63. We will be testing for significant reduction in total depression.

  6. Maternal depression [Change at week 24 from baseline]

    Scores range from 0 to 63. We will be testing for significant reduction in total depression.

  7. Maternal global psychiatric distress [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.

  8. Maternal global psychiatric distress [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT01872585
Other Study ID Numbers:
  • 1004006576
First Posted:
Jun 7, 2013
Last Update Posted:
Apr 2, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Yale University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 2, 2020