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Trial record 48 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

Violence Prevention for Adolescent Girls With Prior Maltreatment (GAIN)

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ClinicalTrials.gov Identifier: NCT02765048
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : May 6, 2016
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Missouri Department of Social Services, Children's Division
Children's Advocacy Services of Greater St. Louis
Information provided by (Responsible Party):
Wendy Auslander, Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
PTSD Depression Aggression Victimization Behavioral: GAIN Program Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Violence Prevention for Adolescent Girls With Prior Maltreatment
Study Start Date : August 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GAIN Program
Subjects randomly assigned to receive the GAIN Program intervention
Behavioral: GAIN Program
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.

No Intervention: Usual Care
Subjects randomly assigned to receive community-based services as part of their usual care



Primary Outcome Measures :
  1. Child's Posttraumatic Stress Disorder Symptom Scale [ Time Frame: Baseline to 3 months ]
  2. Child Depression Inventory [ Time Frame: Baseline to 3 months ]
  3. Aggression-Problem Behavior Frequency Scale [ Time Frame: Baseline to 3 months ]
  4. Aggression-Problem Behavior Frequency Scale: Victim Version [ Time Frame: Baseline to 3 months ]
  5. Child's Posttraumatic Stress Disorder Symptom Scale [ Time Frame: Baseline to 6 months ]
  6. Child Depression Inventory [ Time Frame: Baseline to 6 months ]
  7. Aggression-Problem Behavior Frequency Scale [ Time Frame: Baseline to 6 months ]
  8. Aggression-Problem Behavior Frequency Scale: Victim Version [ Time Frame: Baseline to 6 months ]

Secondary Outcome Measures :
  1. Self-efficacy to Control Anger and Resolve Conflicts Scale [ Time Frame: Baseline to 3 months ]
  2. Social Problem-Solving Inventory: Revised [ Time Frame: Baseline to 3 months ]
  3. Youth Self Report: Externalizing Behaviors [ Time Frame: Baseline to 3 months ]
  4. Youth Self Report: Internalizing Behaviors [ Time Frame: Baseline to 3 months ]
  5. Self-efficacy to Control Anger and Resolve Conflicts Scale [ Time Frame: Baseline to 6 months ]
  6. Social Problem-Solving Inventory: Revised [ Time Frame: Baseline to 6 months ]
  7. Youth Self Report: Externalizing Behaviors [ Time Frame: Baseline to 6 months ]
  8. Youth Self Report: Internalizing Behaviors [ Time Frame: Baseline to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

RCT--

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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--

Caregiver and professional staff inclusion criteria are:

  • 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

Exclusion criteria for caregivers and professional staff are:

-Not interested in participating in one-on-one interviews.

Therapist inclusion criteria are:

  • Led the study's intervention groups with GAIN participants
  • Interested and willing to participate in one-on-one interviews.

Exclusion criteria for therapists are:

-Not interested in participating in one-on-one interviews.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765048


Locations
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United States, Missouri
Comtrea
Arnold, Missouri, United States, 63010
Children's Advocacy Services of Greater St. Louis
St. Louis, Missouri, United States, 63121
Washington University
St. Louis, Missouri, United States, 63130
Sponsors and Collaborators
Washington University School of Medicine
Centers for Disease Control and Prevention
Missouri Department of Social Services, Children's Division
Children's Advocacy Services of Greater St. Louis
Investigators
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Principal Investigator: Wendy Auslander, PhD Washington University School of Medicine

Publications:
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Responsible Party: Wendy Auslander, Barbara A. Bailey Professor of Social Work, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02765048     History of Changes
Other Study ID Numbers: 201111071
R49CE001510 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Wendy Auslander, Washington University School of Medicine:
Adolescent girls
Child welfare
Trauma treatment
PTSD
Depression
Social problem-solving

Additional relevant MeSH terms:
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Depression
Aggression
Behavioral Symptoms