Safe Mothers, Safe Children Initiative

Child Maltreatment Clinical Trial

Official title:

Safe Mothers, Safe Children Initiative

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02522741
• Other study ID #: 11-00175
• Status: Withdrawn
• Phase: N/A
• First received: August 7, 2015
• Last updated: December 21, 2016
• Start date: November 2010
• Est. completion date: April 2016

Study information

• Verified date: December 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Maltreatment

Intervention

Behavioral:
• Parenting STAIR
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.

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	The Structured Clinical Interview for the Diagnostic & Statistical Manual of Mental Disorders (DSM)-IV Axis I Disorders		At baseline	No
Primary	Woman Abuse Screening Tool		At baseline	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	CAGE Substance Abuse Screening Tool		At baseline for individuals not meeting criteria for PTSD	No
Secondary	Yale University PRIME Screening Test		At baseline for individuals not meeting criteria for PTSD	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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)	No