Safe Touches Program for Child Sexual Abuse Prevention

No longer recruiting at 3 trial locations

Overseen By Mia Melchior, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Not in second grade, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of delivering a program to prevent child sexual abuse. One group will experience the program through live puppet skits, while the other will watch prerecorded videos. The researchers aim to determine if both methods are equally effective and if their benefits endure over time. Children who are native English speakers and enrolled in participating second-grade classrooms, with parental permission, are eligible to join. As an unphased trial, this study provides a unique opportunity to contribute to important research that could shape future prevention programs.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Safe Touches program is safe for children?

Research has shown that the Safe Touches program, designed to prevent child sexual abuse, is safe and effective for children in kindergarten through third grade. Solid research supports the program, which has been tested in schools.

This trial compares two versions of the program—Modified Safe Touches and Usual Safe Touches. Both versions teach the same lessons but in different ways. The usual version uses live puppet shows with two presenters, while the modified version uses prerecorded videos with one presenter. Research has not identified any safety issues or negative effects, indicating that both methods are safe and well-received by children.

The trial is labeled "Not Applicable" because it focuses on comparing the effectiveness of the two methods rather than testing a new medical treatment. Safety is not a primary concern, as the program content has already been proven safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Safe Touches Program for child sexual abuse prevention because it explores innovative delivery methods to enhance learning and engagement. The Modified Safe Touches approach stands out by using prerecorded workshop skit videos delivered by a single facilitator, which could make the program more scalable and accessible in varied classroom settings. In contrast, the Usual Safe Touches method relies on live puppet skits performed by two facilitators, allowing for an interactive, traditional engagement style. This trial aims to discover which method is more effective in educating children, potentially setting a new standard in preventive education.

What evidence suggests that this trial's treatments could be effective for child sexual abuse prevention?

A previous study showed that the Safe Touches program significantly improved second- and third-grade students' understanding of inappropriate touch compared to a group that did not receive the program. This demonstrates the program's effectiveness in teaching children to recognize unsafe situations. In this trial, participants will receive either the Modified Safe Touches or the Usual Safe Touches program. Research suggests that both versions are expected to be equally effective in helping children learn. The Modified Safe Touches version uses prerecorded videos, while the Usual Safe Touches version uses live puppet shows. Both methods aim to reach as many children as possible without losing their impact on teaching personal safety. ^{1 5 6 7 8}

Who Is on the Research Team?

Kate Guastaferro, PhD, MPH

Principal Investigator

New York University

Are You a Good Fit for This Trial?

This trial is for second graders with parental permission to participate, who are enrolled in a classroom involved in the study and speak English natively. It aims to prevent child sexual abuse by comparing two versions of the Safe Touches program.

Inclusion Criteria

Parental permission to participate in the research

I am in a second grade class that is part of the study.

I am a native English speaker.

Exclusion Criteria

Not enrolled in a second grade classroom participating in the research

Non-native English speaker

No parental permission to participate in the research

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Safe Touches program in either the usual or modified format

1 day

1 visit (in-person)

Follow-up

Participants are monitored for retention of knowledge and effectiveness of the program

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Modified Safe Touches
• Usual Safe Touches

Trial Overview The study compares the 'usual' delivery method of the Safe Touches program against a 'modified' version to see if they're equally effective at preventing child sexual abuse and maintaining their effectiveness over time.

How Is the Trial Designed?

Group I: Modified Safe Touches Experimental Treatment 1 Intervention

Delivered by 1 facilitator in the classroom by utilizing prerecorded workshop skit videos

Group II: Usual Safe Touches Active Control 1 Intervention

Delivered by 2 facilitators in a classroom by utilizing live puppet skits

Modified Safe Touches is already approved in United States for the following indications:

Approved in United States as Safe Touches for:

• Child sexual abuse prevention

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Published Research Related to This Trial

The Safe Touches workshop, a school-based prevention program for child sexual abuse, was successfully implemented in 718 classrooms across 92% of school districts, reaching approximately 14,235 second graders.

The program significantly increased children's knowledge about child sexual abuse, with these knowledge gains being maintained for up to 12 months after the workshop, demonstrating its long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Universal School-Based Child Sexual Abuse Prevention Program: A Longitudinal Cohort Study. Guastaferro, K., Shipe, SL., Connell, CM., et al.[2023]

A study involving 70 children aged 5 to 6 years in Tehran showed that a child sexual abuse prevention program (CSAPP) significantly improved children's knowledge and self-protective skills after four training sessions, with knowledge scores increasing from 70% to a higher level post-intervention.

The program also highlighted the importance of teaching children about body ownership and assertiveness, as well as the dangers posed by known individuals, to effectively prevent sexual abuse and reduce anxiety about unsafe situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, Skills, and Self-Disclosure Following a Sexual Abuse Prevention Program Among Iranian Preschoolers: A Cluster Quasi-Experimental Controlled Study. Maleki, Z., Damghanian, M., Rad, M., et al.[2023]

The Safe Touches program significantly improved second- and third-grade students' knowledge of inappropriate touch compared to a control group, indicating its effectiveness in a school-based setting with 492 participants over two years.

Younger children, particularly those in second grade and those in schools with more general education students, showed the most significant gains in understanding inappropriate touch, suggesting that early intervention may be particularly beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge Gains Following a Child Sexual Abuse Prevention Program Among Urban Students: A Cluster-Randomized Evaluation. Pulido, ML., Dauber, S., Tully, BA., et al.[2022]

The sexual abuse prevention program showed short-term improvements in children's choice of safety strategies, with 161 participants feeling more capable of refusing unwanted interactions immediately after the program.

However, the program also led to some negative effects, particularly in older children who developed discomfort with physical touch, suggesting the need for adjustments in the program's duration or content to enhance its long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive and negative effects of a child sexual abuse prevention program. Taal, M., Edelaar, M.[2019]

The Play it Safe! program effectively increased knowledge about recognizing, resisting, and reporting abuse among elementary school students, as shown by a significant improvement in scores from pretest to posttest in the intervention group (n = 539).

The program was particularly effective for younger students (third graders) compared to older students (fifth graders), suggesting that age may influence the program's impact on knowledge retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a School-Based Child Physical and Sexual Abuse Prevention Program. Thompson, EL., Zhou, Z., Garg, A., et al.[2022]

The Safe Touches program significantly increased child sexual abuse (CSA)-related knowledge among 2,210 students, demonstrating its effectiveness in a school setting before the COVID-19 pandemic disrupted implementation.

Facilitators expressed support for developing a virtual version of the Safe Touches workshop, highlighting concerns about student engagement and technology access, which are important for maintaining the program's effectiveness in a virtual format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge Gains from the Implementation of a Child Sexual Abuse Prevention Program and the Future of School-Based Prevention Education. Guastaferro, K., Shipe, SL., Connell, CM., et al.[2023]

Child sexual abuse prevention programs, primarily focused on group-based instruction for children, have shown that while children can learn about personal safety, this knowledge does not always translate into sustained behavioral changes.

Programs that incorporate role playing and participant modeling may enhance the effectiveness of these educational efforts, particularly for children aged 7 to 12, and can lead to increased disclosures of abuse, although there are concerns about potential fear and anxiety induced by such programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of child sexual abuse. Daro, DA.[2016]

Two management tools were developed to improve nursing care for children with pressure injuries, validated by focus groups of 17 nurses each at a pediatric hospital in 2018.

The first tool focuses on assessing risk factors, basic human needs, and signs of infection, while the second tool provides a flowchart for risk assessment and prevention, enhancing individualized care for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management tools in nursing care for children with pressure injury. Rodrigues, CBO., Prado, TND., Nascimento, LCN., et al.[2021]

Current school-based education programs for preventing child sexual abuse (CSA) have been effective in increasing children's knowledge and protection skills, but their impact on actually preventing abuse is unclear.

There are concerns that these programs may inadvertently cause anxiety and wariness in children, highlighting the need to shift focus towards educating and empowering parents and caregivers to create safer environments for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reviewing the Focus: A Summary and Critique of Child-Focused Sexual Abuse Prevention. Rudolph, J., Zimmer-Gembeck, MJ.[2019]

A safety collaborative was established to adapt adult pressure injury prevention guidelines for pediatric patients, leading to the development of specific interventions for children.

The initiative highlighted the importance of recognizing and addressing medical device-related pressure injuries in children, which were previously overlooked, thereby raising awareness of pediatric pressure injury prevention as a critical hospital safety issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating a Pediatric and Neonatal Pressure Injury Prevention Program When Evidence Was Sparse or Absent: A View From Here. Nie, AM.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4463397/

Knowledge Gains Following a Child Sexual Abuse Prevention ... Our results suggest that Safe Touches is effective for children from racially/ethnically diverse low-income families; this contrasts with previous ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424000929

Maximizing the reach of universal child sexual abuse ... We will conduct a pragmatic cluster randomized trial to determine the equivalent effectiveness of two delivery modalities of Safe Touches (as usual vs. modified) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06195852

Maximizing the Reach of Universal Child Sexual Abuse ... The study will use a rigorous cluster randomized design to determine the equivalence of effectiveness between two delivery modalities of Safe Touches: as usual ...

4. withpower.com withpower.com/trial/phase-child-sexual-abuse-2024-c0b5d

Safe Touches Program for Child Sexual Abuse Prevention The Safe Touches program significantly improved second- and third-grade students' knowledge of inappropriate touch compared to a control group, indicating its ...

5. pa.gov pa.gov/agencies/pccd/programs-and-services/childrens-advocacy/child-sexual-abuse-prevention-projects

Child Sexual Abuse Prevention Projects The objective of SHCI was to identify the most effective comprehensive child sexual abuse prevention strategy by implementing SOC, Safe Touches, and Smart ...

6. cebc4cw.org cebc4cw.org/program/safe-touches/

CEBC » Program › Safe Touches Safe Touches - A Child Sexual Abuse Prevention Program for Children is designed for children in Kindergarten through third grade (K-3).

7. nyspcc.org nyspcc.org/what-we-do/training-institute/professional-trainings-and-resources/safe-touches/

Safe Touches Program | NYSPCC Safe Touches is an evidence-based, age-appropriate child sexual abuse prevention program designed for children K - 3rd grade. Learn more.

8. rainn.org rainn.org/help-and-healing/hotline/

RAINN's National Sexual Assault Hotline What To Expect When You Contact RAINN. Since 1994, RAINN's victim service programs have helped over 5 million survivors of sexual violence and their loved ones ...