Parent-focused Primary Prevention of Child Sexual Abuse: An Effectiveness-implementation Hybrid Trial
NCT ID: NCT05976867
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
400 participants
INTERVENTIONAL
2024-11-07
2028-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Smart Parents--Safe and Healthy Kids
NCT04366687
Evaluation of HRP Among Pre-K Through 5th Grade
NCT06388850
A Parent-Based Intervention to Reduce Sexual Risk Behavior in Adolescents
NCT01326806
Father-Focused Intervention for Reducing Family Violence and Symptoms in Children
NCT06074068
Maximizing the Reach of Universal Child Sexual Abuse Prevention: An Equivalence Trial
NCT06195852
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A variation of a crossover experimental design, the SW-CRT is a pragmatic experimental design wherein randomized clusters sequentially transition from control to intervention until all clusters are exposed to the intervention. Once introduced to a cluster, the intervention is never removed. Facilitated by PAT National, 25 PAT sites will be recruited at the start of the study period. Sites will then be randomized into 1 of 5 clustered sequences (or steps) each containing 5 sites (or clusters). At the time on randomization, providers at all sites will begin recruiting eligible parents for participation in research and parents will begin the data collection protocols. At the point of the wedge, sites will be trained to deliver Smart Parents and will transition from control (PAT+TAU) to intervention (PAT+Smart Parents) conditions, the timing of which will be determined by the randomized step assignment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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).
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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)
15 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
New York University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
New York University, School of Global Public Health
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.