READY to Stand Curriculum for Preventing Child Sexual Abuse

Overseen By Rochelle M Dalla, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska Lincoln

Disqualifiers: Enrollment in pilot trial

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: Approximately 3 months

3218 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a program called READY to Stand, designed to prevent child sexual abuse. It examines the program's impact on high school students, particularly in reducing child sexual exploitation, teen dating violence, and sexual violence. The trial also measures whether the program encourages students to intervene when witnessing potential abuse. Students in grades 9 to 12 who understand English and attend certain schools are eligible to participate. As an unphased trial, this study offers students the chance to contribute to important research that could enhance safety and well-being in schools.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the READY to Stand Curriculum is safe for students?

Research shows that the READY to Stand Curriculum educates and empowers individuals to prevent the commercial sexual exploitation of children. As an educational program, it does not involve traditional safety concerns like side effects or physical harm. Instead, its effectiveness and outcomes are the primary focus.

Evaluations have assessed the curriculum's impact on students, examining behavioral changes such as reduced exploitation incidents and increased bystander intervention. No negative effects have been reported, as it is an educational program. Its success relies on participants' understanding and engagement.

In summary, the curriculum focuses on teaching and raising awareness, not medical treatment, so concerns like drug side effects are irrelevant. The goal is to educate safely and effectively without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the READY to Stand© curriculum because it takes a proactive approach to preventing child sexual abuse through education, unlike traditional methods that often focus on response and recovery. This curriculum empowers children and educators by providing them with knowledge and tools to recognize and prevent abuse before it happens. Its emphasis on prevention and empowerment sets it apart from existing options that primarily address the aftermath of abuse.

What evidence suggests that the READY to Stand Curriculum is effective for preventing child sexual abuse?

Research on the READY to Stand Curriculum, which participants in this trial may receive, suggests it might help lower the risk of child sexual exploitation. This program teaches students how to prevent these incidents and intervene in dangerous situations. By focusing on awareness and action-oriented skills, the curriculum aims to reduce the likelihood of victimization and perpetration of sexual violence. Although solid evidence on its effectiveness is still being gathered, the program relies on prevention and education, key strategies for addressing these issues. Early signs are encouraging, particularly in enhancing bystander intervention skills. ^{1 2 3 4 6}

Who Is on the Research Team?

Rochelle Dalla, PhD

Principal Investigator

University of Nebraska Lincoln

Lorey Wheeler, PhD

Principal Investigator

University of Nebraska Lincoln

Katie Edwards, Ph.D.

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals who may be at risk of commercial sexual exploitation, specifically children. The goal is to evaluate if the READY to Stand curriculum can help prevent such exploitation and related issues like teen dating violence.

Inclusion Criteria

Able to understand spoken English

I am a high school student in grades 9-12 at an eligible school.

Exclusion Criteria

Enrolled in either of the two schools involved in the corresponding Open Pilot Trial (NCT05988398)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implementation of the READY to Stand© curriculum, consisting of six 45-minute modules for students and training for school personnel

Approximately 3 months

6 sessions (in-person)

Follow-up

Participants complete follow-up surveys to assess outcomes such as reductions in CSEC perpetration and victimization, and increases in bystander intervention

18 months

Surveys at 6, 12, and 18 months post-baseline

Evaluation

Post-program implementation of key informant and stakeholder interviews to assess program impact and variations in implementation

What Are the Treatments Tested in This Trial?

Interventions

• The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum

Trial Overview The Set Me Free Project's READY to Stand curriculum is being tested for its effectiveness in reducing child sexual exploitation and associated risks. Participants will either receive this intervention or be placed in a control group without it.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

READY to Stand© curriculum

Group II: Control Active Control 1 Intervention

control

The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum is already approved in United States for the following indications:

Approved in United States as READY to Stand Curriculum for:

• Prevention of commercial sexual exploitation of children
• Reduction in teen dating violence
• Reduction in sexual violence victimization and perpetration

Who Is Running the Clinical Trial?

University of Nebraska Lincoln

Lead Sponsor

Trials

40

Recruited

13,200+

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

The 'Red Flag Green Flag People' program effectively teaches elementary school children about sexual abuse prevention, with students retaining knowledge for up to 2 years after the program.

This study utilized an 11-question survey to assess knowledge retention, indicating that school-based prevention programs can have a lasting impact on children's understanding of safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bad Touches, Getting Away, and Never Keeping Secrets: Assessing Student Knowledge Retention of the "Red Flag Green Flag People" Program. Wood, M., Archbold, CA.[2019]

An educational program was developed to prevent sexual abuse of children, focusing on safety education and providing children with specific methods to avoid victimization, based on input from parents, teachers, and children.

The program includes essential topics like early detection of abuse, crisis management, and access to counseling, and has been distributed to all elementary schools through the Ministry of Education, indicating a broad commitment to child safety and health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of the educational program for prevention of sexual abuse in children]. Lee, KH., Lee, JH., Bae, JY., et al.[2019]

The 'Women's Safety in Recovery' group therapy model is designed specifically for inpatients and partial hospital patients with histories of childhood sexual abuse, focusing on trauma recovery and coping with current life stressors.

This therapy consists of three flexible one-week modules that allow patients to join or leave at any time, incorporating psychoeducation, problem-solving skills, and supportive discussions to enhance recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's safety in recovery: group therapy for patients with a history of childhood sexual abuse. Talbot, NL., Houghtalen, RP., Cyrulik, S., et al.[2004]

The 'I am learning to protect myself with Mika' program significantly improved preschool children's knowledge about inappropriate touching and personal safety, as measured by the 'What If' Situations Test (WIST).

In a study involving 81 preschool children, those in the intervention group showed greater increases in safety skills compared to the wait-list group, suggesting the program's potential effectiveness for broader implementation in Turkish preschools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of the "I am Learning to Protect Myself with Mika" Program Using the "What If" Situations Test. Eslek, D., Kızıltepe, R., Yılmaz Irmak, T., et al.[2022]

The 'ReSi-Kompetenzförderprogramm' effectively improved various competencies in kindergarteners, including self-assertion, stress management, and conflict resolution, as shown in a randomized-controlled trial with 412 participants.

Children who participated in the program demonstrated increased knowledge about body parts, emotions, and safety strategies, indicating that the program successfully taught age-appropriate preventive knowledge against sexual abuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[ReSi: Evaluation of a Program for Competency Training and Prevention of Sexual Abuse in Kindergarten]. Feldmann, J., Storck, C., Pfeffer, S.[2020]

The S2T (Survivor to Thriver) program, a group intervention for women survivors of childhood sexual abuse, facilitated resilience processes such as constructive rumination and coping strengths, indicating its potential as a healing method.

Participants reported significant posttraumatic growth outcomes, including a transformed life philosophy and a new identity as 'thrivers,' suggesting that the program may effectively support recovery and personal development after trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resilience enabling processes and posttraumatic growth outcomes in a group of women survivors of childhood sexual abuse. Walker-Williams, HJ., Fouché, A.[2022]

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 MBF Child Safety Matters® curriculum significantly improved child safety knowledge among K-5 students, with a moderate effect size (d = 0.29) compared to a control group that did not receive the curriculum.

The study involved 2,414 students across 136 classrooms in Georgia, demonstrating the curriculum's effectiveness in enhancing safety knowledge within a month of implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Child Safety Matters Curriculum for Improving Knowledge about Victimization among Elementary School Children: A Randomized Trial. Weeks, EA., Whitaker, DJ., Pendarvis, S., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06587529

Rigorous Evaluation of the READY to Stand Curriculum ... The overall goal of the five-year project is to conduct both a process and rigorous outcome evaluation of The Set Me Free Project (SMFP)'s READY to Stand ...

2. trialx.com trialx.com/clinical-trials/listings/310765/rigorous-evaluation-of-the-ready-to-stand-curriculum-to-prevent-the-commercial-sexual-exploitation-of-children/?&radius=50

Rigorous Evaluation of the READY to Stand Curriculum ... Overview. The overall goal of the five-year project is to conduct both a process and rigorous outcome evaluation of The Set Me Free Project ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05988398

Preventing Commercial Sexual Exploitation of Children The overall goal of the 5-year project is to conduct both a process and rigorous outcome evaluation of The Set Me Free Projects (SMFP) READY to Stand (RTS) ...

4. setmefreeproject.net setmefreeproject.net/ready-to-stand-curriculum

READY To Stand Curriculum Learn about the READY To Stand Curriculum® by The Set Me Free Project. Empower all ages with knowledge to prevent and intervene in human trafficking.

5. news.unl.edu news.unl.edu/article/nebraska-iowa-collaboration-to-explore-prevention-of-child-sex-trafficking

Nebraska, Iowa collaboration to explore prevention of child ... Researchers will assess student surveys to determine whether participation in READY to Stand reduces child sex trafficking, teen dating violence ...

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06587529?keyword=%22Sex%20Trafficking%22

San Mateo Clinical Trial Rigorous Evaluation of the ... Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children.