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AggressionPhase 3NCT00510094

Effectiveness of Treatment for Relational Aggression in Urban African American Girls

A Phase 3 study testing Friend to Friend program in people with Aggression, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Aggression
What is being tested?
Friend to Friend program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteUnited States
Study dates
Oct 2007to May 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • Enrolled in special education and not integrated into a regular education classroom

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Determining the Efficacy of a Relational Aggression Intervention for Urban African American Girls

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.

Read the 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.

Conditions
Aggression
Being tested
Friend to Friend program, Psychoeducational attention control intervention
Keywords
Social Skills, Anger Management, Relational Aggression
Medical subject headings
Aggression, Social Skills

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Friend to Friend programBehavioural

    Also called Relational aggression intervention

    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 interventionBehavioural

    Also called Homework and study skills 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.

Study groups in NCT00510094
Study groupRoleWhat they receive
1ExperimentalParticipants will receive the Friend to Friend program
Receives: Behavioral: Friend to Friend program
2Active comparatorParticipants will receive the psychoeducational attention control intervention
Receives: Behavioral: Psychoeducational attention control intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peer nominations

    Measured: Measured pre-treatment and immediately post-treatment

  2. Playground observations

    Measured: Measured pre-treatment and immediately post-treatment

  3. Children's Social Behavior Questionnaire

    Measured: Measured pre-treatment and immediately post-treatment and at 9-month follow-up

  4. Social Cognitive Assessment Profile

    Measured: Measured pre-treatment and immediately post-treatment and at 9-month follow-up

  5. Cartoon Based Hostile Attribution Bias Measure

    Measured: Measured pre-treatment and immediately post-treatment and at 9-month follow-up

  6. Knowledge of Anger Problem Solving (KAPS)

    Measured: Measured pre-treatment, immediately post-treatment, and at 9 month follow-up

Secondary outcomes (9)

  1. Discipline referrals and suspensions

    Measured: Measured pre-treatment, immediately post-treatment and at 9-month follow-up

  2. Academic Performance Rating Scale

    Measured: Measured pre-treatment, immediately post-treatment and at 9-month follow-up

  3. Homework Performance Questionnaire

    Measured: Measured pre-treatment, immediately post-treatment and at 9-month follow-up

  4. Asher-Wheeler Loneliness Questionnaire

    Measured: Measured pre-treatment, immediately post-treatment and at 9-month follow-up

  5. Iowa-Conner Aggression subscale

    Measured: Measured pre-treatment, immediately post-treatment and at 9-month follow-up

  6. Student-Teacher Relationship Scale

    Measured: Measured pre-treatment, immediately post-treatment and at 9-month follow-up

  7. Peer Ratings of Aggression and Prosocial Behavior

    Measured: Measured pre-treatment, immediately post-treatment

  8. Harter, Self-Perception Profile for Children

    Measured: Measured pre-treatment, immediately post-treatment, and at 9 month follow-up

  9. Peer Sympathy Scale

    Measured: Measured pre-treatment, immediately post-treatment, and at 9 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionMay 2014
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00510094
Sponsor's protocol ID
2006-10-5013
Other IDs
R01MH075787, DSIR 84-CTS
Status last verified
Jun 2015
First submitted
30 Jul 2007
Last updated
4 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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. doi: 10.1111/j.1467-8624.2006.00939.x.

    PubMed 16999803

  • 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.

  • 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.

    PubMed 19830622

  • 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. doi: 10.1007/s12310-008-9000-7.

    PubMed 19834586

  • 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. doi: 10.1007/s12310-009-9006-9.

    PubMed 20428475

  • 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.

    PubMed 23389773

  • 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.

    PubMed 23086015

  • 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.

    PubMed 22556114

  • 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.

    PubMed 21800228

  • 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.

    PubMed 21686034

  • 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.

    PubMed 20449645

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Friend to Friend program in people with Aggression, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peer nominations (time frame: Measured pre-treatment and immediately post-treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00510094, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.

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