Evaluation of e-Practice Self-Regulation (e-PS-R)

NCT03242447 | Completed

• 1 other identifier: 90AP2679-01-00
• Study Type: interventional
• Target: 631
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the impact of the offer to participate in the e-Practice Self-Regulation (e-PS-R) (treatment) relative to the control condition on increasing knowledge of sexual health and the impact of trauma on sexual decision-making and preventing teen pregnancy and high-risk behaviors 12 months after enrollment.

Conditions

Teen Pregnancy Prevention

Outcome Measures

Primary Outcomes (1)

• participants' self-reported sexual behaviors

  The primary outcome will be the mean differences between the treatment and control group participants in self-reported sexual behaviors at 12-month follow-up; exploratory analyses will examine differences in sexual behaviors post-program and differences in other theoretically relevant outcomes (e.g., attitudes, self-efficacies, self-regulatory behaviors) at both post-program and 12-month follow-up. The independent variable of interest will be the treatment assignment, which will be operationalized as being randomly assigned to the active treatment (1) or the control condition (0).

  12 months after enrollment into the study

Secondary Outcomes (2)

• consistency of contraceptive use

  12 months after enrollment

• frequency of sexual activity

  12 months after enrollment

Study Arms (2)

e-Practice Self-Regulation (e-PS-R)

EXPERIMENTAL

e-Practice Self-Regulation (e-PSR) is the treatment condition. e-PS-R is a 'blended learning' intervention, combining online and face-to-face instruction. e-PS-R aims to increase knowledge of sexual health and the impact of trauma on sexual decision-making.

Behavioral: e-Practice Self-Regulation

Video Health Group

ACTIVE COMPARATOR

The Video Health Group is the control counterfactual condition. Youth assigned to the control group will view a video on a non-sexual health topic (the hazards of smoking).The video for the control condition will be The Toxic Life Cycle of a Cigarette, a 17-minute video that details the negative effects that cigarettes have on the environment and on people who manufacture and use cigarettes. The informational video uses both narration and interviews to educate viewers on the dangers that cigarettes pose.

Behavioral: Video Health Group

Interventions

e-Practice Self-Regulation BEHAVIORAL

e-PS-R utilizes 'blended learning', the combination of online and face-to-face instruction, and incorporates online videos and interactive elements that have been shown to be effective with high-risk youth. e-PS-R consists of eight 30-minute e-learning sessions for youth participants and four 30-45 minute one-on-one in-person meetings between youth and a trained facilitator.

e-Practice Self-Regulation (e-PS-R)

Video Health Group BEHAVIORAL

The video for the control condition will be The Toxic Life Cycle of a Cigarette, a 17-minute video that details the negative effects that cigarettes have on the environment and on people who manufacture and use cigarettes.

Video Health Group

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be aged 14-19
• Be involved with the juvenile justice system
• Be deemed appropriate for study by site staff and study facilitator (no acute illness or behavioral problems; psychiatrically stable; cognitively capable of internalizing and comprehending content of intervention)
• Possess adequate English-language comprehension (be able to read and comprehend the on-line intervention materials, which are available only in English)
• Consent/assent to participating in study

You may not qualify if:

• Not be residing in or scheduled to enter a secure facility
• Not be currently pregnant
• Not be trying to get pregnant
• Not be an enrolled participant (former or current) in the Teen Health Study (Teen Pregnancy Prevention study funded by the Office of Adolescent Health, being conducted in Albuquerque, New Mexico)
• Not have previously participated in e-PS-R

Sponsors & Collaborators

• The Policy & Research Group: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

The Policy & Research Group

New Orleans, Louisiana, 70118, United States

Location

Study Officials

• Eric Jenner, PhD

  The Policy & Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants are assigned to one of two or more groups in parallel for the duration of the study

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 8, 2017
• Study Start: August 2, 2017
• Primary Completion: April 30, 2020
• Study Completion: January 31, 2021
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: The individual participant dataset will become available twelve months after the study has concluded.

Locations

US (1)