Safe Mothers, Safe Children Initiative

Not Applicable

Withdrawn

• Conditions: Child Maltreatment
• Interventions: Behavioral: Parenting STAIR

• Registration Number: NCT02522741
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parenting STAIR	Parenting STAIR	-

Primary Outcome Measures

Name	Time	Method
The Structured Clinical Interview for the Diagnostic & Statistical Manual of Mental Disorders (DSM)-IV Axis I Disorders	At baseline
The Clinician Administered PTSD Scale	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	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	Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Woman Abuse Screening Tool	At baseline
Strengths and Difficulties Questionnaire	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	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	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	Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States