Clinical trial NCT03242447: Evaluation of e-Practice Self-Regulation (e-PS-R)
Official title: Evaluation of e-Practice Self-Regulation (e-PS-R)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Pregnancy Prevention
Lead sponsor: The Policy & Research Group
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2017-08-08
Enrollment: 631
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: PREVENTION

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.

Detailed description: The Policy \& Research Group (PRG) will be conducting a rigorous evaluation of an innovative intervention designed to prevent adolescent pregnancy, births, and STIs among high-risk youth populations, entitled online Practice Self-Regulation (e-PS-R). e-PS-R is the online adaptation of the Practice Self-Regulation (PS-R); both PS-R and e-PS-R were developed through grant funding by Joann Schladale of Resources for Resolving Violence, Inc. The original PS-R intervention is a 10-session therapeutic program designed for youth ages 14-19 who have experienced trauma; each session is intended to be offered by a masters-level therapist during one-on-one weekly therapy sessions. The online adaptation 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. The following Adulthood Preparation Subjects are covered during both the online sessions and the in-person meetings: Adolescent Development, Healthy Life Skills, and Healthy Relationships. By increasing knowledge of sexual health and the impact of trauma on sexual decision-making, the program is designed to encourage and support youth in practicing self-regulation.

The Policy \& Research Group (PRG) will conduct an implementation evaluation and an impact evaluation, using a randomized controlled trial, to test the effectiveness of this new intervention. The study will target juvenile justice-involved youth ages 14-19 who have experienced trauma. The primary focus of the study will be to investigate the impact of the intervention on two self-reported sexual behaviors: (1) inconsistency of condom use, and (2) number of sexual partners. In addition, the study will include exploratory investigations of the following self-reported sexual behaviors and theoretically relevant antecedents to behavior and pathways to behavior change: (1) use of contraception; (2) use of dual methods of protection; (3) incidence of pregnancy; (4) self-efficacy to engage in affect regulation; (5) sexual self-efficacy; (6) intentions to engage in affect-regulation; (7) intentions to engage in sexual self-regulation; and (8) use of affect regulation. Outcomes will be assessed using self-reported, participant-level data gathered (by way of a questionnaire) at four time points: baseline (enrollment); post-program (immediately after the end of the intervention period; 3 months after baseline); short-term (3 months post-intervention period) follow-up; and long-term (nine months post-intervention period) follow-up.

Starting in July 2017 and continuing for two years, 600 participants will be enrolled into the study at partner implementation sites within the juvenile justice systems in New Mexico and West Virginia. The third and fourth years of the grant will be used to complete the following tasks: collect follow-up data from study participants; conduct implementation and impact evaluation analysis, reporting, and dissemination efforts; and manualize and package the curriculum and training materials.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: participants' self-reported sexual behaviors
timeFrame: 12 months after enrollment into the study
Secondary outcomes:
measure: consistency of contraceptive use
timeFrame: 12 months after enrollment
measure: frequency of sexual activity
timeFrame: 12 months after enrollment
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: The Policy & Research Group
state: Louisiana
Study officials:
affiliation: The Policy & Research Group
name: Eric Jenner, PhD
role: PRINCIPAL_INVESTIGATOR
References: