NCT05531409

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
Last Updated

June 12, 2023

Status Verified

September 1, 2022

Enrollment Period

3.7 years

First QC Date

June 28, 2022

Last Update Submit

June 9, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Developmental Differences Between Children and Adolescents

    RBYC aims to educate children about developmental differences between adolescents and younger children. The investigators were unable to identify an existing relevant measure and therefore created seven items to assess knowledge about developmental differences between adolescents and younger children. For example, "Children might feel frustrated when they can't do the same things as teenagers." Response options were true or false and scored as 0 (inaccurate) or 1 (accurate). Scale range = 0-7, with higher scores indicating more accurate understanding of developmental differences between teenagers and younger children.

    2 months

  • Knowledge about CSA and Related Concepts

    Included 41 true/false items coded as 0 (inaccurate) or 1 (accurate) to assess five core areas of knowledge reflecting five subscales: child sexual abuse facts, child sexual abuse laws, child sexual abuse prevention, knowledge about sexual harassment, knowledge about sexual consent Items comprising a given subscale were summed for a subscale score, with higher scores indicating more accurate knowledge.Items were created by the investigators for the study and also adapted from: Adolescent Cognition Scale (Hunter, Becker, Kaplan, \& Goodwin, 1991), Children's Knowledge of Abuse Questionnaire (Tutty, 1995), and Questionnaire on Child Sexual Abuse (Halpérin et al., 1996).

    2 months

  • Peer Sexual Harassment Behaviors

    Included five items assessing peer sexual harassment perpetration created by Taylor and colleagues (2011). For example "Have you ever done any of the following with a peer: Made sexual comments, jokes, gestures, or looks to them?" Response options were no (0) or yes (1) and were summed to provide a final score that ranged from 0-5 with higher scores indicating engaging in more harassing behaviors.

    2 months

  • Behavioral Intention to Avoid or Prevent Harm

    To assess intention to avoid peer sexual harassment, the investigators used five items developed by Taylor and colleagues (Taylor et al., 2011). For example "I can help prevent sexual harassment against peers at my school". Items were measured on a four-point scale ranging from completely disagree (1) to completely agree (4) and summed for scores ranging from 5-20. To assess intention to avoid or prevent CSA, the investigators crafted seven similar items. For example "I know how to teach my friends about how to stop child sexual abuse". Again, response options ranged from completely disagree (1) to completely agree (4) and were summed for scores ranging from 7-28. For both scales, higher scores indicated stronger intention to prevent or avoid harm.

    2 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Behavioral: Responsible Behavior for Younger Children (RBYC)

Waitlist Control

NO INTERVENTION

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).

Interventions

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 Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Behavior

Study Officials

  • Elizabeth J Letourneau, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Pilot randomized waitlist-controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2022

First Posted

September 8, 2022

Study Start

January 1, 2016

Primary Completion

September 11, 2019

Study Completion

September 11, 2019

Last Updated

June 12, 2023

Record last verified: 2022-09