NCT02181647

Brief Summary

The primary goal of the study is to conduct a rigorous evaluation of the sexual abuse prevention program entitled, "Safe Touches: Personal Safety Training for Children (Safe Touches)." The main study hypothesis is that children who receive the Safe Touches intervention will show greater improvement on their knowledge of inappropriate touches compared to children who do not receive the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
492

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2014

Completed
Last Updated

July 4, 2014

Status Verified

July 1, 2014

Enrollment Period

2.2 years

First QC Date

July 2, 2014

Last Update Submit

July 3, 2014

Conditions

Child Sexual Abuse

Outcome Measures

Primary Outcomes (1)

  • Children's Knowledge of Abuse Questionnaire

    up to 4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Safe Touches Personal Safety Training for Children

Behavioral: Safe Touches: Personal Safety Training for Children

Comparison

OTHER

Received Safe Touches after week-1 assessment completed (delayed intervention).

Behavioral: Safe Touches: Personal Safety Training for Children

Interventions

Safe Touches: Personal Safety Training for ChildrenBEHAVIORAL

The intervention includes a 50-minute interactive training and an age-appropriate activity book on personal body safety to take home and complete with caregivers. Using culturally appropriate puppets, workshop facilitators use role-play to model scenarios to help children: a) recognize safe and not-safe touches, b) understand body safety, c) practice assertiveness skills, and d) help children identify whom they can go to for help.

ComparisonIntervention

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • second and third graders at participating New York City public schools
  • at least 7 years old
  • have not participated in Safe Touches program in the past

You may not qualify if:

  • physical, cognitive, or emotional impairment that would affect the child's ability or safety in participating in the workshop or to respond to the questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Society for the Prevention of Cruelty to Children

New York, New York, 10038, United States

Location

Study Officials

  • Mary L. Pulido, Ph.D.

    The New York Society for the Prevention of Cruelty to Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 4, 2014

Study Start

April 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 4, 2014

Record last verified: 2014-07

Locations

US(1)