Program for Caregivers Involved With Mental Health Services

NCT01872585 | Completed Early Phase 1 DMC

• 1 other identifier: 1004006576
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Illness

Keywords

Parenting; Mental Illness; Maternal sensitivity; Parent-child relationship

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Coding Interactive Behavior

  Change at week 12 from baseline

• Coding Interactive Behavior

  Change at week 24 from baseline

• Maternal parenting stress

  Change at week 12 from baseline

• Maternal parenting stress

  Change at week 24 from baseline

• Maternal depression

  Change at week 12 from baseline

Study Arms (1)

Mentalization based therapy

EXPERIMENTAL

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

Interventions

Mentalization based therapy BEHAVIORAL

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

Mentalization based therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

West Haven Mental Health Clinic

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

• 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.

  PMID: 27575343 RESULT

MeSH Terms

Conditions

Mental Disorders

Interventions

Mentalization-Based Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nancy E Suchman, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: June 7, 2013
• Study Start: April 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)