Skip to main content
Clinical Trials/NCT02522741
NCT02522741
Withdrawn
Not Applicable

Safe Mothers, Safe Children Initiative

NYU Langone Health1 site in 1 countryNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Child Maltreatment
Sponsor
NYU Langone Health
Locations
1
Primary Endpoint
The Clinician Administered PTSD Scale
Status
Withdrawn
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
April 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

The Clinician Administered PTSD Scale

Time Frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)

Posttraumatic Stress Diagnostic Scale

Time Frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)

Center for Epidemiological Studies Depression Scale

Time Frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)

The Structured Clinical Interview for the Diagnostic & Statistical Manual of Mental Disorders (DSM)-IV Axis I Disorders

Time Frame: At baseline

Woman Abuse Screening Tool

Time Frame: At baseline

Strengths and Difficulties Questionnaire

Time Frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)

Eyberg Child Behavior Inventory

Time Frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)

Developmental Questionnaire

Time Frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)

Traumatic Events Screening Inventory - Parent Report Revised, Trauma Symptom Checklist for Young

Time Frame: 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

  • Yale University PRIME Screening Test(At baseline for individuals not meeting criteria for PTSD)
  • Connor-Davidson Resilience Scale(Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment))
  • Life Orientation Test-Revised(Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment))
  • The Parenting Stress Index-Short Form(Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment))
  • The Conflict Tactics Scale-Parent-Child(Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment))
  • The Adult-Adolescent Parenting Inventory-2(Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment))
  • CAGE Substance Abuse Screening Tool(At baseline for individuals not meeting criteria for PTSD)
  • Treatment Services Review(Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatme)
  • Interpersonal Support Evaluation List(Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment))
  • State Trait Anger Expression Inventory-2(Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment))
  • Difficulties of Emotional Regulation Scale(Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment))
  • Working Alliance Inventory Short Form for Clients(Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment))

Study Sites (1)

Loading locations...

Similar Trials