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

NCT05976867 | Recruiting DMC

• 1 other identifier: R01HD108209
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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. 1.Does PAT + Smart Parents improve parents' CSA-related awareness and protective behaviors compared to PAT as usual?
2. 2.Are potential gains maintained 12- and 24-months post intervention?
3. 3.What parent-, provider-, and organizational-level factors hold promise for future dissemination and implementation efforts?

Conditions

Child Sexual Abuse

Keywords

primary prevention; child sexual abuse; implementation science

Outcome Measures

Primary Outcomes (10)

• Assessment of Sexual Abuse Knowledge

  The Assessment of SmartParents Knowledge will be used to evaluate (a) CSA knowledge, norms, and attitudes (e.g., items regarding the degree to which parents endorsed accurate facts about CSA, the role of a parent in CSA prevention, and what is appropriate to discuss with children), and (b) intention to use CSA prevention related behaviors (e.g., items regarding identifying signs of CSA, talking to children and other adults about CSA prevention, and knowing how to respond appropriately if CSA is suspected).

  Baseline (T0)

• Assessment of Sexual Abuse Knowledge

  The Assessment of SmartParents Knowledge will be used to evaluate (a) CSA knowledge, norms, and attitudes (e.g., items regarding the degree to which parents endorsed accurate facts about CSA, the role of a parent in CSA prevention, and what is appropriate to discuss with children), and (b) intention to use CSA prevention related behaviors (e.g., items regarding identifying signs of CSA, talking to children and other adults about CSA prevention, and knowing how to respond appropriately if CSA is suspected).

  Up to 4 months (Post Session 6) (T1)

• Assessment of Sexual Abuse Knowledge

  The Assessment of SmartParents Knowledge will be used to evaluate (a) CSA knowledge, norms, and attitudes (e.g., items regarding the degree to which parents endorsed accurate facts about CSA, the role of a parent in CSA prevention, and what is appropriate to discuss with children), and (b) intention to use CSA prevention related behaviors (e.g., items regarding identifying signs of CSA, talking to children and other adults about CSA prevention, and knowing how to respond appropriately if CSA is suspected).

  12-month assessment (T2)

• Assessment of Sexual Abuse Knowledge

  The Assessment of SmartParents Knowledge will be used to evaluate (a) CSA knowledge, norms, and attitudes (e.g., items regarding the degree to which parents endorsed accurate facts about CSA, the role of a parent in CSA prevention, and what is appropriate to discuss with children), and (b) intention to use CSA prevention related behaviors (e.g., items regarding identifying signs of CSA, talking to children and other adults about CSA prevention, and knowing how to respond appropriately if CSA is suspected).

  24-month assessment (T3)

• Parental Use of Behavioral Strategies Interview

  The Parental Use of Behavioral Strategies Interview (PUBSI) is a project created semi-structured behavioral interview deeply assess the use of behavior strategies at four levels: (1) community-level intentions, awareness, and behaviors; (2) personal environment; (3) personal actions/behaviors; and (4) personal behaviors. In addition to parents' reports of behaviors across the four levels, parents rate (on a scale of 1 to 5) their confidence in their ability to engage in each behavior as well as as their success in communicating with others about the various CSA related topics assessed.

  12-month assessment (T2)

• Parental Use of Behavioral Strategies Interview

  The Parental Use of Behavioral Strategies Interview (PUBSI) is a project created semi-structured behavioral interview deeply assess the use of behavior strategies at four levels: (1) community-level intentions, awareness, and behaviors; (2) personal environment; (3) personal actions/behaviors; and (4) personal behaviors. In addition to parents' reports of behaviors across the four levels, parents rate (on a scale of 1 to 5) their confidence in their ability to engage in each behavior as well as as their success in communicating with others about the various CSA related topics assessed.

  24-month assessment (T3)

• Preventive Behaviors Questionnaire

  A 10-item instrument designed to assess the frequency with which parents perform protective behaviors within the past month (e.g., "Told my child never to keep secrets about touching" or "Talked to my relatives about my child's personal safety rules."). This quantitative assessment of behaviors will complement the PUBSI.

  Baseline (T0)

• Preventive Behaviors Questionnaire

  A 10-item instrument designed to assess the frequency with which parents perform protective behaviors within the past month (e.g., "Told my child never to keep secrets about touching" or "Talked to my relatives about my child's personal safety rules."). This quantitative assessment of behaviors will complement the PUBSI.

  Up to 4 months (Post Session 6) (T1)

• Preventive Behaviors Questionnaire

  A 10-item instrument designed to assess the frequency with which parents perform protective behaviors within the past month (e.g., "Told my child never to keep secrets about touching" or "Talked to my relatives about my child's personal safety rules."). This quantitative assessment of behaviors will complement the PUBSI.

  12-month assessment (T2)

• Preventive Behaviors Questionnaire

  A 10-item instrument designed to assess the frequency with which parents perform protective behaviors within the past month (e.g., "Told my child never to keep secrets about touching" or "Talked to my relatives about my child's personal safety rules."). This quantitative assessment of behaviors will complement the PUBSI.

  24-month assessment (T3)

Study Arms (2)

PAT + Smart Parents

EXPERIMENTAL

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.

Behavioral: Parents as Teachers (PAT) + Smart Parents

PAT as usual

ACTIVE COMPARATOR

Participants in this arm will continue to receive Parents as Teachers (PAT) as usual. This is the treatment as usual condition (comparison).

Behavioral: Parents as Teachers (PAT) as usual

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.

PAT as usual

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.

PAT + Smart Parents

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• New York University: lead

Study Sites (1)

New York University, School of Global Public Health

New York, New York, 10003, United States

RECRUITING

Central Study Contacts

Kate Guastaferro, PhD, MPH

CONTACT

2129929032; kate.guastaferro@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: August 4, 2023
• Study Start: November 7, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (1)