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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00510094
Other study ID # 2006-10-5013
Secondary ID R01MH075787DSIR
Status Completed
Phase Phase 3
First received July 30, 2007
Last updated June 3, 2015
Start date October 2007
Est. completion date May 2015

Study information

Verified date June 2015
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date May 2015
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (11)

Blom-Hoffman J, Leff SS, Franko DL, Weinstein E, Beakley K, Power TJ. Consent Procedures and Participation Rates in School-Based Intervention and Prevention Research: Using a Multi-Component, Partnership-Based Approach to Recruit Participants. School Ment Health. 2009 Mar 1;1(1):3-15. — View Citation

Gullan RL, Feinberg BE, Freedman MA, Jawad A, Leff SS. Using Participatory Action Research to Design an Intervention Integrity System in the Urban Schools. School Ment Health. 2009 Sep 1;1(3):118-130. — View Citation

Leff SS, Cassano M, MacEvoy JP, Costigan T. Initial validation of a knowledge-based measure of social information processing and anger management. J Abnorm Child Psychol. 2010 Oct;38(7):1007-20. doi: 10.1007/s10802-010-9419-9. — View Citation

Leff SS, Crick NR, Angelucci J, Haye K, Jawad AF, Grossman M, Power TJ. Social cognition in context: validating a cartoon-based attributional measure for urban girls. Child Dev. 2006 Sep-Oct;77(5):1351-8. — View Citation

Leff SS, Gullan RL, Paskewich BS, Abdul-Kabir S, Jawad AF, Grossman M, Munro MA, Power TJ. An initial evaluation of a culturally adapted social problem-solving and relational aggression prevention program for urban African-American relationally aggressive girls. J Prev Interv Community. 2009;37(4):260-74. doi: 10.1080/10852350903196274. — View Citation

Leff SS, Lefler EK, Khera GS, Paskewich B, Jawad AF. Preliminary examination of a cartoon-based hostile attributional bias measure for urban African American boys. Am J Community Psychol. 2012 Jun;49(3-4):332-46. doi: 10.1007/s10464-011-9461-y. — View Citation

Leff SS, Waasdorp TE, Paskewich B, Gullan RL, Jawad AF, Macevoy JP, Feinberg BE, Power TJ. The Preventing Relational Aggression in Schools Everyday Program: A Preliminary Evaluation of Acceptability and Impact. School Psych Rev. 2010 Dec;39(4):569-587. — View Citation

Leff SS, Waasdorp TE. Effect of aggression and bullying on children and adolescents: implications for prevention and intervention. Curr Psychiatry Rep. 2013 Mar;15(3):343. doi: 10.1007/s11920-012-0343-2. Review. — View Citation

Leff, S. S., Angelucci, J., Goldstein, A. B., Cardaciotto, L., Paskewich, B., & Grossman, M. (2007). Using a participatory action research model to create a school-based intervention program for relationally aggressive girls: The Friend to Friend Program. In J. Zins, M. Elias, & C. Maher (Eds.), Bullying, Victimization, and Peer Harassment: Handbook of Prevention and Intervention in Peer Harassment, Victimization, and Bullying (199-218). New York. Haworth Press.

Macevoy JP, Leff SS. Children's sympathy for peers who are the targets of peer aggression. J Abnorm Child Psychol. 2012 Oct;40(7):1137-48. doi: 10.1007/s10802-012-9636-5. — View Citation

Waasdorp TE, Baker CN, Paskewich BS, Leff SS. The association between forms of aggression, leadership, and social status among urban youth. J Youth Adolesc. 2013 Feb;42(2):263-74. doi: 10.1007/s10964-012-9837-9. Epub 2012 Oct 20. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Peer nominations Measured pre-treatment and immediately post-treatment No
Primary Playground observations Measured pre-treatment and immediately post-treatment No
Primary Children's Social Behavior Questionnaire Measured pre-treatment and immediately post-treatment and at 9-month follow-up No
Primary Social Cognitive Assessment Profile Measured pre-treatment and immediately post-treatment and at 9-month follow-up No
Primary Cartoon Based Hostile Attribution Bias Measure Measured pre-treatment and immediately post-treatment and at 9-month follow-up No
Primary Knowledge of Anger Problem Solving (KAPS) Measured pre-treatment, immediately post-treatment, and at 9 month follow-up No
Secondary Discipline referrals and suspensions Measured pre-treatment, immediately post-treatment and at 9-month follow-up No
Secondary Academic Performance Rating Scale Measured pre-treatment, immediately post-treatment and at 9-month follow-up No
Secondary Homework Performance Questionnaire Measured pre-treatment, immediately post-treatment and at 9-month follow-up No
Secondary Asher-Wheeler Loneliness Questionnaire Measured pre-treatment, immediately post-treatment and at 9-month follow-up No
Secondary Iowa-Conner Aggression subscale Measured pre-treatment, immediately post-treatment and at 9-month follow-up No
Secondary Student-Teacher Relationship Scale Measured pre-treatment, immediately post-treatment and at 9-month follow-up No
Secondary Peer Ratings of Aggression and Prosocial Behavior Measured pre-treatment, immediately post-treatment No
Secondary Harter, Self-Perception Profile for Children Measured pre-treatment, immediately post-treatment, and at 9 month follow-up No
Secondary Peer Sympathy Scale Measured pre-treatment, immediately post-treatment, and at 9 month follow-up No
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