Responsible Behavior With Younger Children Pilot Study

NCT ID: NCT05531409

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-09-11

Brief Summary

The purpose of this study was to develop and pilot test a universal school-based prevention curriculum to prevent the onset of child sexual abuse (CSA) perpetration by early adolescents against younger children.

Detailed Description

The proposed Responsible Behavior with Younger Children (RBYC) curriculum was developed and pilot tested in 6th and 7th grade classes in Baltimore City Public Schools. This study had three aims: 1) to develop and refine a new classroom-based universal curriculum to prevent the onset of CSA perpetration, 2) to evaluate the immediate effects (pre-post design) of RBYC on targeted constructs, and 3) to determine the feasibility and acceptability of RBYC to youth, parents, and school personnel.

Conditions

Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Arm

Students from 6th and 7th grades from two schools were randomized to receive the RBYC curriculum. The RBYC curriculum has eight core content sessions, each of which lasts approximately 45 minutes. These include sessions that address: 1) Developmental differences between children versus teenagers; 2) Perspective-taking of and empathic responding to younger children; 3) and 4) Healthy versus unhealthy teenage-younger child relationships; 5) Misconceptions versus facts about child sexual abuse and legal ramifications; 6) Why adolescents may engage in harmful sexual behaviors; 7) Peer sexual harassment, what it is and how to avoid or address it; and 8) Being a good bystander or upstander when you have concerns that another child or peer has been or may be harmed. The RBYC curriculum was integrated into each school's existing health education curriculum.

Group Type: EXPERIMENTAL

Responsible Behavior for Younger Children (RBYC)

Intervention Type: BEHAVIORAL

RBYC is a school-based universal prevention program designed to provide adolescents and their parents (or other guardians) with the knowledge and tools to help adolescents interact appropriately with younger children and avoid engaging younger children in sexual behaviors.

Waitlist Control

Students from 6th and 7th grades from the two schools that were randomized to the waitlist control condition received the RBYC curriculum once the study was completed (i.e., baseline and post-assessment data were collected).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Responsible Behavior for Younger Children (RBYC)

RBYC is a school-based universal prevention program designed to provide adolescents and their parents (or other guardians) with the knowledge and tools to help adolescents interact appropriately with younger children and avoid engaging younger children in sexual behaviors.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Student Assessments: 1) are in a 6th or 7th grade class within one of the four participating schools, 2) are fluent in English, and 3) have a "yes" consent form completed by their parent/legal guardian; students will also be asked to complete an electronic assent form at the beginning of each of the three student assessments.
• Educator Interviews: 1) have witnessed at least one session of the RBYC curriculum, 2) are fluent in English, and 3) have completed a consent form

Exclusion Criteria

• Children residing in foster care will not be eligible for participation because of challenges associated with obtaining written parental consent from the legal guardian and other clinical concerns regarding this potentially vulnerable population that may arise with either students or parents. It is not feasible to address these challenges in the study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

University of Maryland

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth J Letourneau, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Other Identifiers

IRB00007351

Identifier Type: -

Identifier Source: org_study_id