Clinical trial NCT05976867: Parent-focused Primary Prevention of Child Sexual Abuse: An Effectiveness-implementation Hybrid Trial
Official title: Parent-focused Primary Prevention of Child Sexual Abuse: An Effectiveness-implementation Hybrid Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Sexual Abuse
Keywords: primary prevention
child sexual abuse
implementation science
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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?

Detailed description: To expand the empirical evidence for the effectiveness of Smart Parents and to explore the implementation factors that might promote or hinder adoption, fidelity, and scalability, the proposed study uses a type 2 hybrid effectiveness-implementation design. Designed to efficiently bridge the research to practice gap, the type 2 hybrid design tests the effectiveness of an intervention while concurrently exploring the viability of an explicit implementation strategy in a real world setting. To determine effectiveness (Aims 1 \& 2), the investigators will conduct a pragmatic, quasi-experimental, stepped wedge cluster randomized trial (SW-CRT; N = 400) of CSA-related awareness (i.e., knowledge and attitudes about CSA and CSA prevention) and intention to use CSA protective behaviors for parents receiving Smart Parents when added to PAT (PAT+Smart Parents) compared to parents receiving PAT treatment as usual (PAT-TAU; Aim 1). The investigators will follow-up participating parents in both conditions at 12- and 24-months to determine retention of awareness (i.e., knowledge and attitudes) and actual use of protective behaviors (Aim 2).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of Sexual Abuse Knowledge
timeFrame: Baseline (T0)
measure: Assessment of Sexual Abuse Knowledge
timeFrame: Up to 4 months (Post Session 6) (T1)
measure: Assessment of Sexual Abuse Knowledge
timeFrame: 12-month assessment (T2)
measure: Assessment of Sexual Abuse Knowledge
timeFrame: 24-month assessment (T3)
measure: Parental Use of Behavioral Strategies Interview
timeFrame: 12-month assessment (T2)
measure: Parental Use of Behavioral Strategies Interview
timeFrame: 24-month assessment (T3)
measure: Preventive Behaviors Questionnaire
timeFrame: Baseline (T0)
measure: Preventive Behaviors Questionnaire
timeFrame: Up to 4 months (Post Session 6) (T1)
measure: Preventive Behaviors Questionnaire
timeFrame: 12-month assessment (T2)
measure: Preventive Behaviors Questionnaire
timeFrame: 24-month assessment (T3)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University, School of Global Public Health
state: New York
Study officials:
References: