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Effectiveness of Treatment for Relational Aggression in Urban African American Girls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00510094
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : June 4, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE July 30, 2007
First Posted Date  ICMJE August 1, 2007
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE October 2007
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2010)
  • Peer nominations [ Time Frame: Measured pre-treatment and immediately post-treatment ]
  • Playground observations [ Time Frame: Measured pre-treatment and immediately post-treatment ]
  • Children's Social Behavior Questionnaire [ Time Frame: Measured pre-treatment and immediately post-treatment and at 9-month follow-up ]
  • Social Cognitive Assessment Profile [ Time Frame: Measured pre-treatment and immediately post-treatment and at 9-month follow-up ]
  • Cartoon Based Hostile Attribution Bias Measure [ Time Frame: Measured pre-treatment and immediately post-treatment and at 9-month follow-up ]
  • Knowledge of Anger Problem Solving (KAPS) [ Time Frame: Measured pre-treatment, immediately post-treatment, and at 9 month follow-up ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
  • Peer nominations [ Time Frame: Immediately post intervention ]
  • Playground observations [ Time Frame: Immediately post intervention ]
  • Children's Social Behavior Questionnaire [ Time Frame: Immediately post intervention and 9-month follow-up ]
  • Social Cognitive Assessment Profile [ Time Frame: Immediately post intervention and 9-month follow-up ]
  • Cartoon Based Hostile Attributional Bias Measure [ Time Frame: Immediately post intervention and 9-month follow-up ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2010)
  • Discipline referrals and suspensions [ Time Frame: Measured pre-treatment, immediately post-treatment and at 9-month follow-up ]
  • Academic Performance Rating Scale [ Time Frame: Measured pre-treatment, immediately post-treatment and at 9-month follow-up ]
  • Homework Performance Questionnaire [ Time Frame: Measured pre-treatment, immediately post-treatment and at 9-month follow-up ]
  • Asher-Wheeler Loneliness Questionnaire [ Time Frame: Measured pre-treatment, immediately post-treatment and at 9-month follow-up ]
  • Iowa-Conner Aggression subscale [ Time Frame: Measured pre-treatment, immediately post-treatment and at 9-month follow-up ]
  • Student-Teacher Relationship Scale [ Time Frame: Measured pre-treatment, immediately post-treatment and at 9-month follow-up ]
  • Peer Ratings of Aggression and Prosocial Behavior [ Time Frame: Measured pre-treatment, immediately post-treatment ]
  • Harter, Self-Perception Profile for Children [ Time Frame: Measured pre-treatment, immediately post-treatment, and at 9 month follow-up ]
  • Peer Sympathy Scale [ Time Frame: Measured pre-treatment, immediately post-treatment, and at 9 month follow-up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
  • Nursing reports of injuries [ Time Frame: Immediately post intervention and 9-month follow-up ]
  • Discipline referrals and suspensions [ Time Frame: Immediately post intervention and 9-month follow-up ]
  • Academic Performance Rating Scale [ Time Frame: Immediately post intervention and 9-month follow-up ]
  • Homework Performance Questionnaire [ Time Frame: Immediately post intervention and 9-month follow-up ]
  • Asher-Wheeler Loneliness Questionnaire [ Time Frame: Immediately post intervention and 9-month follow-up ]
  • Behavior Symptoms Index of the BASC [ Time Frame: Immediately post intervention and 9-month follow-up ]
  • Student-Teacher Relationship Scale [ Time Frame: Immediately post intervention and 9-month follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Treatment for Relational Aggression in Urban African American Girls
Official Title  ICMJE Determining the Efficacy of a Relational Aggression Intervention for Urban African American Girls
Brief Summary This study will evaluate the effectiveness of a school-based social cognitive group treatment in reducing aggression (bullying) among relationally aggressive urban African American girls.
Detailed Description

Relational aggression, also known as "female bullying," is a type of psychological aggression in which covert tactics are used to harm other people and their relationships. These tactics include humiliation, intimidation, coercing, shaming, malicious teasing, shunning, and using other forms of emotional abuse in an attempt to harm others. Although aggressive behavior is typically common among younger children, most children become less aggressive as they mature and develop better interpersonal skills. However, consistent aggressive behavior can lead to further problems and increased violence in the aggressor. In this study, a social cognitive anger management group intervention called Friend to Friend (F2F) will be evaluated as a way to develop more productive social and emotional functioning among relationally aggressive urban African American girls.

Participants will be randomly assigned to either the F2F program or a psycho-educational attention control (PAC) group. All participants will attend 40-minute treatment sessions twice a week for a total of 10 weeks. The sessions will occur during the girls' lunch or recess period. Participants assigned to the F2F program will learn how to identify signs of physiological arousal, react to a potential conflict while generating alternatives to the solution, and apply previously discussed social cognitive strategies to different situations. Culturally specific cartoons, videotape illustrations, and role playing will be used to portray these improved strategies and behaviors. Participants assigned to the PAC group will learn different organization and homework strategies as well as how to improve their study skills in an attempt to improve their overall academic performance. Outcomes will be assessed through observation, school reports, and questionnaires for all participants at baseline, immediately after treatment, and 9 months after treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aggression
Intervention  ICMJE
  • Behavioral: Friend to Friend program
    Friend to Friend arm is a social information processing group treatment to help aggressive girls learn better social problem solving and decision making choices. Participants will learn how to identify signs of physiological arousal, evaluate others' intentions, react to a potential conflict situation, and generate and evaluate alternatives. Treatment sessions are twice per week (30 to 40 minutes per session) for ten weeks.
    Other Name: Relational aggression intervention
  • Behavioral: Psychoeducational attention control intervention
    Psychoeducational attention control group also meets two times per week for 10 weeks to control for nonspecific factors of treatment. Participants learn homework, study skills, and organizational skills.
    Other Name: Homework and study skills intervention
Study Arms  ICMJE
  • Experimental: 1
    Participants will receive the Friend to Friend program
    Intervention: Behavioral: Friend to Friend program
  • Active Comparator: 2
    Participants will receive the psychoeducational attention control intervention
    Intervention: Behavioral: Psychoeducational attention control intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2013)
144
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2007)
140
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for Schools :

  • Urban school located in Southwest Philadelphia
  • Student body is more than 80% African American
  • Large school with at least three classrooms per grade
  • Not currently involved with systematic anti-aggression social skills program

Inclusion Criteria for Participants:

  • In the 3rd, 4th, or 5th grade
  • Meets diagnostic criteria for relational aggression

Exclusion Criteria for Participants:

  • Enrolled in special education and not integrated into a regular education classroom
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00510094
Other Study ID Numbers  ICMJE 2006-10-5013
R01MH075787 ( U.S. NIH Grant/Contract )
DSIR 84-CTS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Stephen S. Leff, PhD Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP