Violence Prevention for Adolescent Girls With Prior Maltreatment

NCT02765048 | Completed

• 2 other identifiers: 201111071R49CE001510
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to adapt and test an evidence-based trauma treatment program for adolescent girls with histories of child maltreatment. The study adapts the CBITS (Cognitive Behavioral Intervention for Trauma in Schools) program for delivery within community-based settings for use with girls assessed and/or served by the child welfare system. The study utilizes a randomized clinical trial that evaluates the effectiveness of the adapted program entitled GAIN (Girls Aspiring toward Independence) compared with a usual care group. Primary outcomes of the intervention are mental health symptoms such as PTSD, depression, and internalizing and externalizing behaviors. Other outcomes include aggressive behaviors, revictimization, and aggression-related beliefs, self-efficacy, and behavioral intentions.

Conditions

PTSD; Depression; Aggression; Victimization

Keywords

Adolescent girls; Child welfare; Trauma treatment; PTSD; Depression; Social problem-solving

Outcome Measures

Primary Outcomes (8)

• Child's Posttraumatic Stress Disorder Symptom Scale

  Baseline to 3 months

• Child Depression Inventory

  Baseline to 3 months

• Aggression-Problem Behavior Frequency Scale

  Baseline to 3 months

• Aggression-Problem Behavior Frequency Scale: Victim Version

  Baseline to 3 months

• Child's Posttraumatic Stress Disorder Symptom Scale

  Baseline to 6 months

• Child Depression Inventory

  Baseline to 6 months

• Aggression-Problem Behavior Frequency Scale

  Baseline to 6 months

• Aggression-Problem Behavior Frequency Scale: Victim Version

  Baseline to 6 months

Secondary Outcomes (8)

• Self-efficacy to Control Anger and Resolve Conflicts Scale

  Baseline to 3 months

• Social Problem-Solving Inventory: Revised

  Baseline to 3 months

• Youth Self Report: Externalizing Behaviors

  Baseline to 3 months

• Youth Self Report: Internalizing Behaviors

  Baseline to 3 months

• Self-efficacy to Control Anger and Resolve Conflicts Scale

  Baseline to 6 months

Study Arms (2)

GAIN Program

EXPERIMENTAL

Subjects randomly assigned to receive the GAIN Program intervention

Behavioral: GAIN Program

Usual Care

NO INTERVENTION

Subjects randomly assigned to receive community-based services as part of their usual care

Interventions

GAIN Program BEHAVIORAL

Receives GAIN, a 10-session program that incorporates cognitive behavioral therapy skills in a group format to address symptoms of trauma such as PTSD and depression related to histories of child maltreatment. GAIN includes the following elements: 1) assertive communication skills and relationship boundaries, 2) understanding the connection between feelings, thoughts, and behaviors, 3) increased personal confidence, 4) how to have healthy relationships and personal safety, and 5) how to cope with stress and anxiety.

GAIN Program

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Girls ages 12-18
• prior history of maltreatment that has been formally investigated and/or assessed by Children's Division
• Youth is interested in participation and provides assent through IRB approved assent forms
• The legal custodian, parent, and Family Support Team support the youth's participation and provide consent through IRB approved consent forms

You may not qualify if:

• Severe learning problems (i.e. can't read and/or write or cognitively impaired)
• actively suicidal or psychotic, as determined by standard protocol of the state
• behavior that would prohibit participation in a group setting or interview
• Qualitative--
• Caregivers of GAIN participants (both experimental and usual care) and professional staff who referred and/or worked with GAIN participants
• Interested and willing to participate in a one-on-one interview
• Not interested in participating in one-on-one interviews.
• Led the study's intervention groups with GAIN participants
• Interested and willing to participate in one-on-one interviews.
• Not interested in participating in one-on-one interviews.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Centers for Disease Control and Prevention: collaborator
• Missouri Department of Social Services, Children's Division: collaborator
• Children's Advocacy Services of Greater St. Louis: collaborator

Study Sites (3)

Comtrea

Arnold, Missouri, 63010, United States

Location

Children's Advocacy Services of Greater St. Louis

St Louis, Missouri, 63121, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Related Publications (2)

• Auslander W, Tlapek SM, Threlfall J, Edmond T, Dunn J. Mental Health Pathways Linking Childhood Maltreatment to Interpersonal Revictimization During Adolescence for Girls in the Child Welfare System. J Interpers Violence. 2018 Apr;33(7):1169-1191. doi: 10.1177/0886260515614561. Epub 2015 Nov 29.

  PMID: 26621036 BACKGROUND

• Auslander W, Sterzing P, Threlfall J, Gerke D, Edmond T. Childhood Abuse and Aggression in Adolescent Girls Involved in Child Welfare: The Role of Depression and Posttraumatic Stress. J Child Adolesc Trauma. 2016;9:1-10. doi: 10.1007/s40653-016-0090-3. Epub 2016 Apr 12.

  PMID: 27152132 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Aggression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Aberrant Motor Behavior in Dementia; Social Behavior

Study Officials

• Wendy Auslander, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Barbara A. Bailey Professor of Social Work

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 6, 2016
• Study Start: August 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 6, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)