Safe Touches: A Rigorous Evaluation of a Sexual Abuse Prevention Program for Children

Child Sexual Abuse Clinical Trial

— Safe Touches  

Official title:

Safe Touches: A Rigorous Evaluation of a Sexual Abuse Prevention Program for Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181647
• Other study ID #: 5R21HD069628
• Status: Completed
• Phase: N/A
• First received: July 2, 2014
• Last updated: July 3, 2014
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: The New York Society for the Prevention of Cruelty to Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary goal of the study is to conduct a rigorous evaluation of the sexual abuse prevention program entitled, "Safe Touches: Personal Safety Training for Children (Safe Touches)." The main study hypothesis is that children who receive the Safe Touches intervention will show greater improvement on their knowledge of inappropriate touches compared to children who do not receive the intervention.

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:

1. 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).

2. To evaluate maintenance of knowledge gains four weeks after intervention (maintenance).

3. To assess intervention costs relative to short-term retention and maintenance four weeks after intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Sexual Abuse

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	New York Society for the Prevention of Cruelty to Children	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The New York Society for the Prevention of Cruelty to Children	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Knowledge of Abuse Questionnaire		up to 4 weeks	No