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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05531409
Other study ID # IRB00007351
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date September 11, 2019

Study information

Verified date September 2022
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date September 11, 2019
Est. primary completion date September 11, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health University of Maryland, University of Virginia

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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