- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02181647
Safe Touches: A Rigorous Evaluation of a Sexual Abuse Prevention Program for Children (Safe Touches)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will conduct a rigorous evaluation of the sexual abuse prevention program entitled, "Safe Touches: Personal Safety Training for Children (Safe Touches)." Founded in 2007, Safe Touches was developed for kindergarteners through third graders, and is conducted in the New York City public school system. The main goal of Safe Touches is to empower children to have personal agency over their bodies thus decreasing the likelihood of being inappropriately sexually touched and increasing the likelihood of disclosure if sexual abuse occurs.
While prior research provides some data regarding the efficacy of school-based child sexual abuse (CSA) prevention programs, evidence is profoundly marginal. First, most studies were not designed for multicultural populations, and therefore cannot inform what is effective in populations as diverse as New York City. A review of 22 studies evaluating school-based CSA prevention programs found just eight studies that used ethnically diverse samples, only one of which used a randomly assigned concurrent control group--however, this study had a very small sample size. Further, only three of the studies explored the mediating effects of factors such as gender and ethnicity on outcomes. The authors of those studies recommend future research that includes diverse samples and investigates differences in child characteristics more systematically--these recommendations are incorporated into the design and analysis plan of the current study. Second, statistical methods applied to data from prior studies were limited. A meta-analysis of 15 randomized controlled trials (RCTs) of school-based CSA prevention programs found that 10 studies used statistical analyses inappropriate for their particular design, thus increasing the risk for bias. Further, none of the 15 RCTs reported using the intention-to-treat principle. Third, no prior research has evaluated the cost of these programs relative to what children learn. In light of how common these programs are and the lack of valid evidence as to their efficacy, this study will determine their relative value with regard to acquisition of protective skills by addressing the first and second methodological gaps mentioned above, and expanding the scope to include the third, cost-effectiveness.
Study aims are:
- To determine the significance of the difference in effectiveness between the Intervention and Control groups with regard to changes in children's recognition of unsafe touches/situations/people and acquisition of self-protective skills (short-term retention).
- To evaluate maintenance of knowledge gains four weeks after intervention (maintenance).
- To assess intervention costs relative to short-term retention and maintenance four weeks after intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10038
- New York Society for the Prevention of Cruelty to Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- second and third graders at participating New York City public schools
- at least 7 years old
- have not participated in Safe Touches program in the past
Exclusion Criteria:
- physical, cognitive, or emotional impairment that would affect the child's ability or safety in participating in the workshop or to respond to the questionnaire.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
Safe Touches Personal Safety Training for Children
|
The intervention includes a 50-minute interactive training and an age-appropriate activity book on personal body safety to take home and complete with caregivers.
Using culturally appropriate puppets, workshop facilitators use role-play to model scenarios to help children: a) recognize safe and not-safe touches, b) understand body safety, c) practice assertiveness skills, and d) help children identify whom they can go to for help.
|
OTHER: Comparison
Received Safe Touches after week-1 assessment completed (delayed intervention).
|
The intervention includes a 50-minute interactive training and an age-appropriate activity book on personal body safety to take home and complete with caregivers.
Using culturally appropriate puppets, workshop facilitators use role-play to model scenarios to help children: a) recognize safe and not-safe touches, b) understand body safety, c) practice assertiveness skills, and d) help children identify whom they can go to for help.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Children's Knowledge of Abuse Questionnaire
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mary L. Pulido, Ph.D., The New York Society for the Prevention of Cruelty to Children
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5R21HD069628 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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