Safe Mothers, Safe Children Initiative

NCT02522741 | Withdrawn

• 1 other identifier: 11-00175
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Maltreatment

Outcome Measures

Primary Outcomes (9)

• 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)

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

  At baseline

• 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 Outcomes (12)

• 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

• Yale University PRIME Screening Test

  At baseline for individuals not meeting criteria for PTSD

Study Arms (1)

Parenting STAIR

EXPERIMENTAL

Behavioral: Parenting STAIR

Interventions

Parenting STAIR BEHAVIORAL

Parenting-STAIR is an adaptation of a 16 session study therapy entitled Skills Training in Affective and Interpersonal Regulation/Modified Prolonged Exposure (STAIR/MPE). It generally is comprised of approximately 23 sessions and includes seven didactic interaction parenting sessions. There are threskill building in areas such as e modules within Parenting STAIR: 1) Module 1 focuses on skill building (awareness of emotional states, management of negative feelings, regulation of emotional intensity, etc.); 2) Module 2 involves the processing of memories of trauma and creating a coherent and meaningful life narrative; 3) Module 3 includes both the mother and child, and focuses on increasing maternal attunement and improving parenting skills.

Parenting STAIR

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Study Officials

• Claude Chemtob

  NYU MEDICAL CENTER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 13, 2015
• Study Start: November 1, 2010
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

US (1)