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

Обзор

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?

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• New York University, School of Global Public Health — New York

Идентификаторы

NCT: NCT05976867 · R01HD108209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗