Safe Touches Program for Child Sexual Abuse Prevention

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

26 Participants Needed

Trial Summary

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 data supports the effectiveness of the Safe Touches Program for Child Sexual Abuse Prevention treatment?

Research shows that the Safe Touches program, a school-based child sexual abuse prevention treatment, significantly increases children's knowledge about abuse, and these knowledge gains are maintained for at least 12 months after the program. ^{1 2 3 4 5}

Is the Safe Touches Program for Child Sexual Abuse Prevention safe for children?

The Safe Touches Program, a school-based child sexual abuse prevention program, has been widely implemented and evaluated, showing significant knowledge gains among children without reported safety concerns. However, some studies suggest that such programs may cause fear and anxiety in children, though research on these negative impacts is limited and mixed. ^{1 2 4 6 7}

How does the Safe Touches Program differ from other treatments for child sexual abuse prevention?

The Safe Touches Program is unique because it is a universal, school-based prevention program that significantly increases children's knowledge about child sexual abuse and maintains these knowledge gains for up to 12 months after a single session. Unlike other treatments, it focuses on educating children in a classroom setting to recognize and respond to potential abuse situations. ^{1 2 8 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to test the equivalence of two delivery modalities of a universal child sexual abuse prevention program, Safe Touches: usual vs. modified. The aims are to: 1. Determine the equivalence of effectiveness between usual and modified Safe Touches 2. Assess the maintenance of gains between usual and modified Safe Touches 3. Examine factors that may impact the future dissemination and implementation

Research Team

Kate Guastaferro, PhD, MPH

Principal Investigator

New York University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Implementation of a Universal School-Based Child Sexual Abuse Prevention Program: A Longitudinal Cohort Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Knowledge Gains Following a Child Sexual Abuse Prevention Program Among Urban Students: A Cluster-Randomized Evaluation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Prevention of child sexual abuse. [2016]

5. Brazil pubmed.ncbi.nlm.nih.gov

Management tools in nursing care for children with pressure injury. [2021]

6. United States 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. [2023]

7. United States 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Positive and negative effects of a child sexual abuse prevention program. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a School-Based Child Physical and Sexual Abuse Prevention Program. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Reviewing the Focus: A Summary and Critique of Child-Focused Sexual Abuse Prevention. [2019]