Clinical trial NCT06112912: Components Study of REAL Essentials
Official title: Components Study of REAL Essentials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Components of REAL Essentials
Keywords: Components
Relationship education
Content
Dosage
Delivery mechanism
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2023-11-02
Enrollment: 1301
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth enrolled in schools where REA is offered through the study. Youth must have active parental consent for data collection to be included in the study.

Brief summary: The Components Study of REAL Essentials (REA) is a descriptive implementation and outcome study. This study aims to identify the components that matter most for promoting positive health behaviors and outcomes among adolescents. The study will examine a variety of components to determine which are most influential in predicting participant outcomes. In addition, the study will measure youth engagement in programming from various perspectives and examine the role of engagement as an intermediary factor to achieving youth outcomes.

Detailed description: Sites participating in the study used the REA relationship education curriculum, a popular program among federal Teen Pregnancy Prevention (TPP) and Sexual Risk Avoidance Education (SRAE) grantees. The program is intentionally flexible, and each participating school selected a subset of the 87available lessons to meet the needs of the population it serves; the selected lessons comprised the site-specific scope and implementation sequence. Schools offered different lessons and total dosage, and facilitators had various levels of experience with the curriculum, and various backgrounds and facilitation quality. The variation in program delivery, coupled with diverse participant backgrounds, created different REA experiences for participating youth. The study capitalized on this variation to examine which program components were most predictive of variation in participant outcomes.

The study enrolled 1,301 youth across 27 schools in Spring 2022 and Fall 2022. The study collected youth outcome surveys at baseline and at program exit. The immediate follow-up survey enabled the study to explore how variation in components influences outcomes proximal to the REA content, which largely included antecedents to sexual behavior and optimal health. A six-month follow-up survey enabled the study to explore how program components influenced distal behavioral and optimal health outcomes.

In addition to the outcome data, the study collected extensive implementation data. Program facilitators completed logs after delivering each class to enable the study to determine whether facilitators delivered program content and activities, whether they adapted lessons, and the extent to which youth appeared engaged in the lesson. Facilitators also documented attendance at each class session to provide detailed dosage data for youth. Study staff independently observed a subset of classes and REA trainings and interviewed and hold focus groups with facilitators and youth.

The study measured youth engagement through brief exit tickets with youth (surveys administered after each class); facilitators' reports of perceived engagement; independent in-person observations; and in a small number of sites, video recordings of youth faces coded with artificial intelligence to determine how strongly the measures of youth engagement correlate with each other and which was most predictive of youth outcomes.

Eligibility criteria: Inclusion Criteria:

* Enrolled in a school recruited for the study, in a classroom/grade prioritized by school leadership
* Provided consent for data collection

Exclusion Criteria:

* None

Primary outcomes:
measure: Conflict management skills (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Emotion regulation (survey scale)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Future orientation (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Healthy relationship skills, knowledge, attitudes (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Peer pressure resistance (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Perceptions of sex in media and online (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Problem-solving skills (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Responsible decision making (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Self-awareness (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Self-esteem (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Sexual behavior intentions (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Sexual health knowledge (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Social awareness (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Social support (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
Secondary outcomes:
measure: Happiness (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Life satisfaction (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Mental health (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Relationship satisfaction (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Sexual behavior (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Sexually Transmitted Infections (STIs) (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
measure: Substance use (survey scales)
timeFrame: Immediate post (roughly 3 weeks post baseline); long term follow-up (roughly 6 months post baseline)
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Mathematica
state: New Jersey
Study officials:
References: