Recruiting

Observational Study

Sponsor:

New York University

Code:

NCT05976867

Conditions

Child Sexual Abuse

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

Parents as Teachers (PAT) as usual

Parents as Teachers (PAT) + Smart Parents

Study Details

Brief summary:

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?

Conditions

Child Sexual Abuse

Study ID

NCT05976867

Start date

Nov 7, 2024

Status verified date

Jun, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • One parent per household that is currently enrolled in PAT qualified to receive bi-weekly visits;
  • English or Spanish speaking;
  • Has at least one child at home over 12-mo;
  • Only newly enrolled parents (i.e., parents who have not received more than 3 of the PAT foundational sessions).

Exclusion Criteria:

  • Not currently enrolled in PAT;
  • Not English or Spanish speaking;
  • Does not have a child over 12-mo old;
  • Previously enrolled in PAT (i.e., parents who have received more than 3 of the PAT foundational sessions)

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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).

Interventions

Parents as Teachers (PAT) as usual

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

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.

Primary outcome measure

  • Assessment of Sexual Abuse Knowledge [ Time Frame: Baseline (T0) ]
  • Assessment of Sexual Abuse Knowledge [ Time Frame: Up to 4 months (Post Session 6) (T1) ]
  • Assessment of Sexual Abuse Knowledge [ Time Frame: 12-month assessment (T2) ]
  • Assessment of Sexual Abuse Knowledge [ Time Frame: 24-month assessment (T3) ]
  • Parental Use of Behavioral Strategies Interview [ Time Frame: 12-month assessment (T2) ]
  • Parental Use of Behavioral Strategies Interview [ Time Frame: 24-month assessment (T3) ]
  • Preventive Behaviors Questionnaire [ Time Frame: Baseline (T0) ]
  • Preventive Behaviors Questionnaire [ Time Frame: Up to 4 months (Post Session 6) (T1) ]
  • Preventive Behaviors Questionnaire [ Time Frame: 12-month assessment (T2) ]
  • Preventive Behaviors Questionnaire [ Time Frame: 24-month assessment (T3) ]

Central Contacts and Locations

Central contacts

Kate Guastaferro, PhD, MPH

2129929032kate.guastaferro@nyu.edu

Locations

New York University, School of Global Public Health

Recruiting

New York, New York, United States, 10003

Contacts

Kate Guastaferro, PhD MPH

212-992-9032smartparentsstudy@nyu.edu

More Information

Sponsor

New York University

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Keywords

  • primary prevention
  • child sexual abuse
  • implementation science

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2025-06-11.