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

Trial Summary

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 data supports the effectiveness of the READY to Stand Curriculum for preventing child sexual abuse?

The effectiveness of similar educational programs, like the 'I am Learning to Protect Myself with Mika' and the MBF Child Safety Matters® curriculum, shows promise in increasing children's knowledge of personal safety and inappropriate touching recognition, suggesting that the READY to Stand Curriculum may also be effective in preventing child sexual abuse. ^{1 2 3 4 5}

How is the READY to Stand Curriculum different from other treatments for preventing child sexual abuse?

The READY to Stand Curriculum by The Set Me Free Project is unique because it focuses on a comprehensive educational approach to prevent child sexual abuse, unlike other programs that may focus solely on knowledge retention or specific skills. It aims to empower children with knowledge and strategies to recognize and respond to inappropriate situations, potentially offering a more holistic prevention strategy. ^{4 5 6 7 8}

What is the purpose of this trial?

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 (RTS)© curriculum with an eye toward widespread dissemination to other U.S. communities, if deemed effective. Broadly, the investigators seek to determine the effect participation has on students: reductions in commercial sexual exploitation of children (CSEC) perpetration (the primary outcome); reductions in CSEC victimization, teen dating violence (TDV), and sexual violence victimization and perpetration; as well as increases in bystander intervention in CSEC situations compared to participants in the control condition (secondary outcomes).

Research Team

Katie Edwards, Ph.D.

Principal Investigator

University of Michigan

Lorey Wheeler, PhD

Principal Investigator

University of Nebraska Lincoln

Rochelle Dalla, PhD

Principal Investigator

University of Nebraska Lincoln

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 '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 '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]

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 '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]

References

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

Evaluation of the Child Safety Matters Curriculum for Improving Knowledge about Victimization among Elementary School Children: A Randomized Trial. [2021]

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

Women's safety in recovery: group therapy for patients with a history of childhood sexual abuse. [2004]

3. South Africa pubmed.ncbi.nlm.nih.gov

Resilience enabling processes and posttraumatic growth outcomes in a group of women survivors of childhood sexual abuse. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

[Development of the educational program for prevention of sexual abuse in children]. [2019]

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

An Evaluation of the "I am Learning to Protect Myself with Mika" Program Using the "What If" Situations Test. [2022]

6. United States 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. [2019]

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

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

8. Germany pubmed.ncbi.nlm.nih.gov

[ReSi: Evaluation of a Program for Competency Training and Prevention of Sexual Abuse in Kindergarten]. [2020]