MedPath

Program for Caregivers Involved With Mental Health Services

Early Phase 1
Completed
Conditions
Mental Illness
Interventions
Behavioral: Mentalization based therapy
Registration Number
NCT01872585
Lead Sponsor
Yale University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
18
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
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Mentalization based therapyMentalization based therapyWomen 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.
Primary Outcome Measures
NameTimeMethod
Maternal reflective functioningChange 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
NameTimeMethod
Coding Interactive BehaviorChange 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 global psychiatric distressChange 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.

Maternal parenting stressChange 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 depressionChange at week 24 from baseline

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

Trial Locations

Locations (1)

West Haven Mental Health Clinic

🇺🇸

West Haven, Connecticut, United States

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