Program for Caregivers Involved With Mental Health Services

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Illness
• Intervention / Treatment: Behavioral: Mentalization based therapy

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • West Haven Mental Health Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Maternal depression	Scores range from 0 to 63. We will be testing for significant reduction in total depression.	Change at week 12 from baseline
Maternal depression	Scores range from 0 to 63. We will be testing for significant reduction in total depression.	Change at week 24 from baseline
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
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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Nancy E Suchman, PhD, Yale University

Publications and helpful links

General Publications

• 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. doi: 10.1080/14616734.2016.1226371. Epub 2016 Aug 30.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: April 27, 2012
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (ESTIMATE): June 7, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Parenting; Mental Illness; Maternal sensitivity; Parent-child relationship
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 1004006576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO