Parent-focused Primary Prevention of Child Sexual Abuse: An Effectiveness-implementation Hybrid Trial

Part of paid clinical trials in New York, New York.

Sponsor
New York University
Study ID
NCT05976867
Status
Recruiting

Conditions

  • Child Sexual Abuse

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Parents as Teachers (PAT) as usual — BEHAVIORAL
    Parents as Teachers parent-education program as designed. Delivered in the home to parents of children under 5. Parents begin with the foundational curriculum (mostly taught within the first six sessions) focused on healthy child development, parenting behaviors including parent-child interactions and communication, and creating a safe home environment in terms of avoiding accidents and injuries. After the foundational curriculum, additional sessions are delivered based on the continued needs of the family until the child ages out or the parent discontinues services. PAT uses development-centered parenting, family well-being, and community connections to reinforce this foundational curriculum.
  • Parents as Teachers (PAT) + Smart Parents — BEHAVIORAL
    Added session to PAT following foundational visit 6. Smart Parents is comprised of 3 CSA specific prevention components: (1) healthy child sexual development, (2) communication about sexual concepts and sexual behaviors, and (3) safety strategies (including online safety. Delivered in one session (\~60 min). Parents return to PAT as usual following this session.

Study Details

The goal of this clinical trial is to test the effectiveness of a parent-focused child sexual abuse prevention program (Smart Parents) delivered to parents enrolled in a parent education program (Parents as Teachers; PAT). The main questions the trial aims to answer are: 1. Does PAT + Smart Parents improve parents' CSA-related awareness and protective behaviors compared to PAT as usual? 2. Are potential gains maintained 12- and 24-months post intervention? 3. What parent-, provider-, and organizational-level factors hold promise for future dissemination and implementation efforts?

Key Dates

Start date
Nov 7, 2024
Status verified
Jun 2025
Primary completion
Apr 1, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PAT + Smart Parents
    Participants in this arm will receive the additional Smart Parents module, added to Parents as Teachers (PAT) in which they are already enrolled. This is the experimental condition.
  • Active Comparator: PAT as usual
    Participants in this arm will continue to receive Parents as Teachers (PAT) as usual. This is the treatment as usual condition (comparison).

Primary Outcome Measure

Assessment of Sexual Abuse Knowledge [ Time Frame: Baseline (T0) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York University, School of Global Public HealthNew YorkNew York10003
Kate Guastaferro, PhD MPH
212-992-9032

Find similar trials in New York, NY