NCT05976867 · New York University
Parent-focused Primary Prevention of Child Sexual Abuse: An Effectiveness-implementation Hybrid Trial
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
Assessment of Sexual Abuse Knowledge
Time frame: Baseline (T0)
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).
Assessment of Sexual Abuse Knowledge
Time frame: Up to 4 months (Post Session 6) (T1)
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).
Assessment of Sexual Abuse Knowledge
Time frame: 12-month assessment (T2)
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).
Assessment of Sexual Abuse Knowledge
Time frame: 24-month assessment (T3)
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).
Parental Use of Behavioral Strategies Interview
Time frame: 12-month assessment (T2)
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.
Parental Use of Behavioral Strategies Interview
Time frame: 24-month assessment (T3)
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.
Preventive Behaviors Questionnaire
Time frame: Baseline (T0)
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.
Preventive Behaviors Questionnaire
Time frame: Up to 4 months (Post Session 6) (T1)
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.
Preventive Behaviors Questionnaire
Time frame: 12-month assessment (T2)
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.
Preventive Behaviors Questionnaire
Time frame: 24-month assessment (T3)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- New York, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2025 · Source of record for eligibility and locations