Clinical trial NCT02522741: Safe Mothers, Safe Children Initiative
Official title: Safe Mothers, Safe Children Initiative
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Child Maltreatment
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of an evidence-based post-traumatic stress disorder (PTSD) intervention adapted to focus on parenting-related impairment for mothers receiving preventive services. The study intervention is adapted from Skills Training in Affective and Interpersonal Regulation (STAIR). The investigators expect that the adaption (Parenting STAIR) has the potential to prevent child maltreatment as well as improve maternal and child well-being by reducing the effects of maternal PTSD and depression on parenting.

The investigators plan to recruit mothers with high levels of trauma-related symptoms from preventive service agencies, and invite them to participate in the study. This study is a single group design, and data will be collected pre-treatment, post-treatment, and 12-week follow-up.


Eligibility criteria: Inclusion Criteria:

* Mothers who are receiving preventive services at the time of study enrollment and have histories of trauma, have symptoms of PTSD, without a history of psychotic disorder, or current domestic violence or substance abuse
* Have a child within the 2-9 age range, and are the child's primary caretaker
* Can communicate in English and/or Spanish

Exclusion Criteria:

* Women who have a history of psychotic disorder and/or who meet current DSM-IV criteria for abuse of drug or alcohol
* Women who are experiencing domestic violence at the time of the assessment
* Pregnant women are excluded from this pilot study because they are a potentially particularly vulnerable population. However, women who become pregnant while participating in the study will not be excluded
* Women who report suicidal ideation in the past two weeks on the SCID, or have a history of a suicide attempt during the last year as reported during the SCID interview
* Children who meet diagnostic criteria for developmental disorders (e.g., autism and mental retardation), and/or have a history of childhood psychosis

Primary outcomes:
measure: The Clinician Administered PTSD Scale
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: Posttraumatic Stress Diagnostic Scale
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: Center for Epidemiological Studies Depression Scale
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: The Structured Clinical Interview for the Diagnostic & Statistical Manual of Mental Disorders (DSM)-IV Axis I Disorders
timeFrame: At baseline
measure: Woman Abuse Screening Tool
timeFrame: At baseline
measure: Strengths and Difficulties Questionnaire
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: Eyberg Child Behavior Inventory
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: Developmental Questionnaire
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: Traumatic Events Screening Inventory - Parent Report Revised, Trauma Symptom Checklist for Young
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Secondary outcomes:
measure: The Parenting Stress Index-Short Form
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: The Conflict Tactics Scale-Parent-Child
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: The Adult-Adolescent Parenting Inventory-2
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: CAGE Substance Abuse Screening Tool
timeFrame: At baseline for individuals not meeting criteria for PTSD
measure: Yale University PRIME Screening Test
timeFrame: At baseline for individuals not meeting criteria for PTSD
measure: Connor-Davidson Resilience Scale
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: Interpersonal Support Evaluation List
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: Life Orientation Test-Revised
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: State Trait Anger Expression Inventory-2
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: Difficulties of Emotional Regulation Scale
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
measure: Treatment Services Review
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatme
measure: Working Alliance Inventory Short Form for Clients
timeFrame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU MEDICAL CENTER
name: Claude Chemtob
role: PRINCIPAL_INVESTIGATOR
References: