Clinical trial NCT04164472: NIH R01 Friend to Friend With Coaching
Official title: The Friend to Friend Program: Effectiveness When Conducted by School Staff
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aggression
Keywords: Relational Aggression
Aggression
Indicated intervention
Universal prevention
School-based
Urban
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-11-15
Enrollment: 5250
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: This study examines the effectiveness of the Friend to Friend (F2F) program when conducted by teachers and counselors with active coaching from the research team. The project involves 14 small group sessions for relationally aggressive girls and 8 classroom sessions. Students, teachers, counselors and parents at intervention and control schools fill out pre- and post- program questionnaires.

Detailed description: This study takes a proven effective program (Friend to Friend) that was initially run by the research team in a clinical trial and examines for the first time its effectiveness when conducted by teachers and counselors with active coaching from the research team. The primary target population for this study will be 4th-5th grade relationally aggressive girls. In intervention schools, these girls will participate in Friend to Friend with Coaching (14 small group sessions, 8 classroom sessions and additional pre- and post- program questionnaires).

In both intervention and control schools all 4th-5th grade students (boys and girls) will participate in a screening measure to identify the relational aggressors and pre- and post-program questionnaires. Counselors and 4th-5th grade teachers in both conditions will participate in pre/post questionnaires and will also participate in training, coaching, the small group intervention and classroom sessions in intervention schools.

These procedures will be repeated with new students in 5 of the F2F with Coaching schools the following school year, except that the research team will provide minimal coaching to staff running the intervention in year 2.

Eligibility criteria: Aim 1 Inclusion/Exclusion Criteria:

* Inclusion Criteria for Schools

  40 schools will be selected on the basis of the following inclusion criteria:
  1. Urban school from the School District of Philadelphia
  2. Predominately minority student body (\> 80%)
  3. Relatively large school with at least 2 classrooms per grade
  4. School is not currently involved in a systematic anti-aggression or bullying prevention program
  5. School must have at least 1 school counselor who is interested in participating
* Inclusion Criteria for Students

  1. All boys and girls in regular education 4th-5th grade classrooms will be eligible to participate in screening and outcome assessment activities.
  2. Screening will include a peer-rating procedure that will be utilized to identify girls with relational aggression (GRAs).
  3. GRAs will be based on if they score \> .50 of a Standard Deviation above mean on relational aggression on the peer-rating measure. These identified girls will be recruited (with written parent consent and student assent) to participate in the F2F with Coaching or control condition.
* Inclusion Criteria for Parents

  1) All parents of students in regular education 4th-5th grade classrooms will be eligible to participate in outcome assessment activities. Starting in year 4, parent recruitment will focus on parents of indicated girls.
* Inclusion Criteria for Teachers/Counselors

  1. Teachers/counselors employed by the participating school sites who provide their verbal consent for participation.
  2. Teachers/counselors who currently teach and/or provide services to students in 4th-5th grade.

Exclusion Criteria:

* Exclusion Criteria for Students

  1) Students who do not speak English. 2) Students whose parents do not speak English or one of the foreign languages into which the Parent Information Sheet for Child Participation has been translated (who therefore cannot opt their child in or out of the study in an informed manner).

  3) Special education students who are not integrated within the regular education classroom.

  4) In intervention schools, boys are excluded from the F2F small group intervention, however, as noted above, all boys will participate in the class portion of the program. Boys in both conditions will complete screening and outcome assessment activities.
* Exclusion Criteria for Parents

  1) Parents who do not speak English or one of the foreign languages into which the Parent Information Sheet for Parent Participation and parent questionnaires have been translated.

  2) Parents of students in special education who are not integrated within the regular education classroom.
* Exclusion Criteria for Teachers/Counselors

  1. Teachers/counselors who do not speak English.
  2. Teachers/counselors who are not working with 4th-5th grade students at the participating school sites.

Aim 2: Inclusion/Exclusion Criteria

* Aim 2 Inclusion Criteria - Schools 1) 10 of Friend to Friend with Coaching schools in Aim 1 will participate in Aim 2.
* Aim 2 Inclusion Criteria - Students

  1. 4th grade boys and girls who meet the same criteria as described in Aim 1.
  2. Similar to Aim 1, a peer rating procedure will be used to identify girls with relational aggression (GRAs) and prosocial role models.
* Aim 2 Inclusion Criteria - Parents 1) Same as Aim 1.

Aim 2 Inclusion Criteria - Teachers/Counselors 1) Counselors and 4th grade teachers who participated in F2F with Coaching in Aim 1.

Aim 2 Exclusion Criteria - Students, Parents, Teacher/Counselors

1) Same as Aim 1.

Primary outcomes:
measure: Change in hostile attribution biases
timeFrame: Given two times throughout the study, first at baseline (early in the school year, October/November) and up to 8 months later
measure: Change in Knowledge of Anger Problem-Solving Steps
timeFrame: Given two times throughout the study, first at baseline (early in the school year, October/November) and up to 8 months later
measure: Change in Relational Aggression
timeFrame: Given two times throughout the study, first at baseline (early in the school year, October/November) and up to 8 months later
measure: Change in Prosocial Leadership
timeFrame: Given two times throughout the study, first at baseline (early in the school year, October/November) and up to 8 months later
measure: Change in Teacher-Student Relationships
timeFrame: Given two times throughout the study, first at baseline (early in the school year, October/November) and up to 8 months later
measure: Change in Staff Self-Efficacy for Handling Aggression
timeFrame: Given two times throughout the study, first at baseline (early in the school year, October/November) and on up to 8 months later
Secondary outcomes:
measure: Explore peer rejection as mediator/moderator
timeFrame: Given two times throughout the study, first at baseline (early in the school year, October/November) and up to 8 months later.
measure: Explore perception of intervention attributes as mediator/moderator
timeFrame: Up to 8 months after the study began.
measure: Explore student self-efficacy for non-violence
timeFrame: Given two times throughout the study, first at baseline (early in the school year, October/November) and up to 8 months later.
measure: Explore implementation factors
timeFrame: This will be first administered during the first session/lesson in the school year (approximately October/November) and to be filled out weekly by facilitators for up to 8 months.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References:
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