Clinical trial NCT01872585: Program for Caregivers Involved With Mental Health Services
Official title: Feasibility Study of a Mentalization-based Parenting Program for Female Caregivers Involved in Mental Health Services.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Mental Illness
Keywords: Parenting
Mental Illness
Maternal sensitivity
Parent-child relationship
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Maternal reflective functioning
timeFrame: Change at week 12 from baseline
measure: Maternal reflective functioning
timeFrame: Change at week 24 from baseline
Secondary outcomes:
measure: Coding Interactive Behavior
timeFrame: Change at week 12 from baseline
measure: Coding Interactive Behavior
timeFrame: Change at week 24 from baseline
measure: Maternal parenting stress
timeFrame: Change at week 12 from baseline
measure: Maternal parenting stress
timeFrame: Change at week 24 from baseline
measure: Maternal depression
timeFrame: Change at week 12 from baseline
measure: Maternal depression
timeFrame: Change at week 24 from baseline
measure: Maternal global psychiatric distress
timeFrame: Change at week 12 from baseline
measure: Maternal global psychiatric distress
timeFrame: Change at week 24 from baseline
Other outcomes:
Locations:
city: West Haven
country: United States
facility: West Haven Mental Health Clinic
state: Connecticut
Study officials:
affiliation: Yale University
name: Nancy E Suchman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.