Child Sexual AbuseNCT06195852
Maximizing the Reach of Universal Child Sexual Abuse Prevention: An Equivalence Trial
A study testing Usual Safe Touches and Modified Safe Touches in people with Child Sexual Abuse, run by New York University at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Sexual Abuse
- What is being tested?
- Usual Safe Touches and Modified Safe Touches
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Sep 2024to 21 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in a second grade classroom participating in the research
- Native English speaker
- Parental permission to participate in the research
Who cannot join
- Not enrolled in a second grade classroom participating in the research
- Non-native English speaker
- No parental permission to participate in the research
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Weller Health Education at Lehigh Valley Health Network
Allentown, Pennsylvania, 18104
Northern Dauphin County YMCA
Elizabethville, Pennsylvania, 17023
Centre County (Centre Safe & Youth Service Bureau)
State College, Pennsylvania, 16803
York County Children's Advocacy Center
York, Pennsylvania, 17403
About this study
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:
- Determine the equivalence of effectiveness between usual and modified Safe Touches
- Assess the maintenance of gains between usual and modified Safe Touches
- Examine factors that may impact the future dissemination and implementation
Read the detailed description
Child sexual abuse (CSA) is a public health problem affecting 1 in 5 girls and 1 in 12 boys before age 18. National estimates indicate children ages 7 to 13 are at highest risk for CSA and CSA is associated with lifelong negative sequelae. School-based prevention programs offer cost-effective universal programming teaching students an array of personal safety skills. Several programs have demonstrated effectiveness in increasing children's knowledge of self-protection, and some have been linked with facilitating disclosures, including Safe Touches. Effectiveness notwithstanding, the programmatic reach of universal school-based programs is limited by the inherent reliance on school infrastructure and a dearth of available alternative delivery modalities. The current study is designed to address this gap by leveraging an existing partnership between university-based researchers (NYU), the Safe Touches model developer (NYSPCC), and community-based organizations with active implementations of Safe Touches. The study will use a rigorous cluster randomized design to determine the equivalence of effectiveness between two delivery modalities of Safe Touches: as usual vs. modified. The usual workshop will be delivered by two facilitators with live puppet skits, as designed (N=90). Whereas, the modified workshop will be delivered by one facilitator utilizing pre recorded skit videos (N=90). The research team will determine the equivalence of concept learning acquisition (Aim 1) and retention (Aim 2) among students in classrooms that receive the as usual or modified workshop. To conclude equivalence, it is important to examine factors that may impact future dissemination and implementation, specifically program adoption among school personnel and implementation fidelity (Aim 3). Study findings will inform the ongoing development of effective CSA prevention programs and policy decisions regarding the sustainable integration of such programs within schools. Given the scope and burden of CSA, especially among elementary aged students, it is a public health priority to efficiently disseminate effective school-based prevention programs on a wide scale.
- Conditions
- Child Sexual Abuse
- Being tested
- Usual Safe Touches, Modified Safe Touches
- Keywords
- prevention, universal prevention, school-based intervention, Safe Touches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Safe TouchesBehavioural
The in-person Safe Touches workshop is delivered in the classroom by 2 facilitators with live puppet skits, as designed.
Modified Safe TouchesBehavioural
The modified Safe Touches workshop will be delivered by 1 facilitator in the classroom by utilizing prerecorded workshop skit videos.
| Study group | Role | What they receive |
|---|---|---|
| Usual Safe Touches | Active comparator | Delivered by 2 facilitators in a classroom by utilizing live puppet skits Receives: Behavioral: Usual Safe Touches |
| Modified Safe Touches | Experimental | Delivered by 1 facilitator in the classroom by utilizing prerecorded workshop skit videos Receives: Behavioral: Modified Safe Touches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Children's Knowledge of Abuse Questionnaire
6-items rated on 3- point scale (Yes, Unsure, No) where higher scores indicate a greater knowledge of safe and unsafe touches
Measured: Pre-workshop, immediately post-workshop, 1-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Sep 2024
- Primary completion21 Apr 2025
- Study completion21 Apr 2025
Why it stopped: Low participation rates from school entities invited to participate in research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Sexual AbuseStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Guastaferro, PhD, MPH, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195852
- Sponsor's protocol ID
- R21HD110822
- Status last verified
- Apr 2025
- First submitted
- 8 Dec 2023
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guastaferro K, Melchior MS, Heng S, Trudeau J, Holloway JL. Maximizing the reach of universal child sexual abuse prevention: Protocol for an equivalence trial. Contemp Clin Trials Commun. 2024 Jul 31;41:101345. doi: 10.1016/j.conctc.2024.101345. eCollection 2024 Oct.
PubMed 39188413
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing the Reach of Universal Child Sexual Abuse Prevention: An Equivalence Trial
- ClinicalTrials.gov ID
- NCT06195852
- Acronym / sponsor ID
- R21HD110822
- Conditions
- Child Sexual Abuse
- Keywords
- prevention, universal prevention, school-based intervention, Safe Touches
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low participation rates from school entities invited to participate in research.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 21 Apr 2025 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the equivalence of effectiveness between usual and modified Safe Touches
- Assess the maintenance of gains between usual and modified Safe Touches
- Examine factors that may impact the future dissemination and implementation
Detailed description
Child sexual abuse (CSA) is a public health problem affecting 1 in 5 girls and 1 in 12 boys before age 18. National estimates indicate children ages 7 to 13 are at highest risk for CSA and CSA is associated with lifelong negative sequelae. School-based prevention programs offer cost-effective universal programming teaching students an array of personal safety skills. Several programs have demonstrated effectiveness in increasing children's knowledge of self-protection, and some have been linked with facilitating disclosures, including Safe Touches. Effectiveness notwithstanding, the programmatic reach of universal school-based programs is limited by the inherent reliance on school infrastructure and a dearth of available alternative delivery modalities. The current study is designed to address this gap by leveraging an existing partnership between university-based researchers (NYU), the Safe Touches model developer (NYSPCC), and community-based organizations with active implementations of Safe Touches. The study will use a rigorous cluster randomized design to determine the equivalence of effectiveness between two delivery modalities of Safe Touches: as usual vs. modified. The usual workshop will be delivered by two facilitators with live puppet skits, as designed (N=90). Whereas, the modified workshop will be delivered by one facilitator utilizing pre recorded skit videos (N=90). The research team will determine the equivalence of concept learning acquisition (Aim 1) and retention (Aim 2) among students in classrooms that receive the as usual or modified workshop. To conclude equivalence, it is important to examine factors that may impact future dissemination and implementation, specifically program adoption among school personnel and implementation fidelity (Aim 3). Study findings will inform the ongoing development of effective CSA prevention programs and policy decisions regarding the sustainable integration of such programs within schools. Given the scope and burden of CSA, especially among elementary aged students, it is a public health priority to efficiently disseminate effective school-based prevention programs on a wide scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Safe Touches | Active comparator | Behavioral: Usual Safe TouchesDelivered by 2 facilitators in a classroom by utilizing live puppet skits |
| Modified Safe Touches | Experimental | Behavioral: Modified Safe TouchesDelivered by 1 facilitator in the classroom by utilizing prerecorded workshop skit videos |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Enrolled in a second grade classroom participating in the research
- Native English speaker
- Parental permission to participate in the research
Key exclusion criteria (3 listed)
- Not enrolled in a second grade classroom participating in the research
- Non-native English speaker
- No parental permission to participate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Safe TouchesThe in-person Safe Touches workshop is delivered in the classroom by 2 facilitators with live puppet skits, as designed. | Behavioural | Usual Safe Touches |
| Modified Safe TouchesThe modified Safe Touches workshop will be delivered by 1 facilitator in the classroom by utilizing prerecorded workshop skit videos. | Behavioural | Modified Safe Touches |
Primary outcome
Modified Children's Knowledge of Abuse Questionnaire
Time frame: Pre-workshop, immediately post-workshop, 1-month follow up
6-items rated on 3- point scale (Yes, Unsure, No) where higher scores indicate a greater knowledge of safe and unsafe touches
Results and safety
The study was stopped early (reason given: Low participation rates from school entities invited to participate in research.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Derived from this study: PubMed 39188413Guastaferro K, Melchior MS, Heng S, Trudeau J, Holloway JL. Maximizing the reach of universal child sexual abuse prevention: Protocol for an equivalence trial. Contemp Clin Trials Commun. 2024 Jul 31;41:101345. doi: 10.1016/j.conctc.2024.101345. eCollection 2024 Oct.
- Individual participant dataSharing planned: No
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Partner
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Guastaferro, PhD, MPH principal investigator
New York University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Safe Touches and Modified Safe Touches in people with Child Sexual Abuse, run by New York University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low participation rates from school entities invited to participate in research.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Children's Knowledge of Abuse Questionnaire (time frame: Pre-workshop, immediately post-workshop, 1-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06195852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.