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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04227236
Other study ID # 1R41HD094406
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2019
Est. completion date April 17, 2019

Study information

Verified date January 2020
Source RAND
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed virtual training prototype will provide Making Proud Choices (MPC) facilitator trainees the opportunity to make decisions, build facilitator skills, practice core concepts and enhance self-efficacy with a virtual audience programmed to display a range of behaviors and emotions, simulating a true-to-life experience with immediate feedback. Seventy-two adults who have experience working with adolescents but not with MPC, STI, or pregnancy prevention education will receive MPC training. Participants will be randomly assigned to either: 1) virtual training in the MPC module on condom use n=36), or 2) dfusion/ETR's traditional in-person training in the same module (n=36). Using mixed methods (survey, focus groups, observations), the project will evaluate the virtual training's impact on STI/pregnancy prevention knowledge, teaching efficacy, and teaching skills and its usability, feasibility, and acceptability.


Description:

Dfusion, in partnership with the RAND Corporation, Allen Interactions and Dr. Loretta Jemmott (MPC developer), proposes to develop an online avatar-based virtual training that can make MPC training more accessible while still being as effective as in-person. In this Phase I STTR, we will develop and test a prototype of the online, avatar-based virtual training for activities of MPC and test it with 72 adults who have experience working with adolescents (but not with MPC or any HIV/STI/teen pregnancy risk-reduction program). At random, 36 will receive traditional in-person MPC training, and 36 will receive avatar-based MPC training. The avatar group (n=36) will be compared to the in-person group (n=36) on their STI/pregnancy prevention knowledge, teaching efficacy, and teaching skills.

The scientific premise is that avatar-based virtual training will prepare educators to implement the popular evidence-based MPC as effectively as traditional (and expensive) face-to-face trainings. The specific aims are:

- Aim 1: Develop a prototype for a novel, online avatar-based virtual training for select components of the evidence-based STI/pregnancy risk reduction program Making Proud Choices.

- Aim 2: Using mixed methods (survey, focus groups, observations), evaluate the avatar-based training's preliminary impact on facilitator STI/pregnancy prevention knowledge, teaching efficacy, and teaching skills compared to in-person training, as well as its usability and acceptability.

By developing novel tools/platforms to improve the dissemination and implementation of evidence-based behavioral interventions to prevent STIs/teen pregnancy, this application is in line with the priorities of the NICHD Population Dynamics Branch, which supports reproductive health research on STIs and family planning. If successful, not only will dfusion proceed to Phase II, but the findings could inform other nascent efforts to develop avatar facilitator trainings that could make a range of evidence-based programs more accessible to community-based organizations.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date April 17, 2019
Est. primary completion date April 17, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- age 21+ and have no prior experience with MPC or providing STI or pregnancy prevention education

Exclusion Criteria:

- non-English speaking

Study Design


Related Conditions & MeSH terms


Intervention

Other:
E-based virtual facilitator training for Making Proud Choices
Participants complete the Making Proud Choices (MPC) facilitator training using an e-based virtual trainer on a computer. Making Proud Choices! (MPC) is an evidence-based pregnancy and HIV/STI risk-reduction program for youth. The facilitator training prepares educators to effectively deliver the MPC curriculum.
In-person facilitator training for Making Proud Choices
Participants complete the Making Proud Choices (MPC) facilitator training using the standard in-person training method. Making Proud Choices! (MPC) is an evidence-based pregnancy and HIV/STI risk-reduction program for youth. The facilitator training prepares educators to effectively deliver the MPC curriculum.

Locations

Country Name City State
United States Dfusion, Inc Scotts Valley California

Sponsors (2)

Lead Sponsor Collaborator
RAND DFUSION, INC.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implementation Fidelity Participants teach an activity that is video recorded and coded for fidelity to the Making Proud Choices curriculum. Participants are scored on completion of curriculum tasks, ability to answer sensitive questions, ability to foster a safe and inclusive environment, and engagement of students. Each of the nine sub-activities from the Making Proud Choices module were rated independently by two coders as 2=done correctly, 1=done partially correct, or 0=not done correctly. up to 1 hour post teacher training
Primary Pre-Training Knowledge of Condom Line-Up Activity 7-item survey measure of knowledge related to condom safety and objectives of the condom line-up module of Making Proud Choices. Responses were coded as correct (1) and incorrect (0). 30 minutes before teacher training
Primary Post-Training Knowledge of Condom Line-Up Activity 7-item survey measure of knowledge related to condom safety and objectives of the condom line-up module of Making Proud Choices. Responses were coded as correct (1) and incorrect (0). 30 minutes after teacher training
Primary Pre-Training Teaching Self-efficacy 4-item self-efficacy measure assessing confidence in teaching condom safety, rated from 1 (not at all) to 7(extremely). Scores were averaged to create a self-efficacy scale score. 30 minutes before teacher training
Primary Post-Training Teaching Self-efficacy 4-item self-efficacy measure assessing confidence in teaching condom safety, rated from 1 (not at all) to 7(extremely). Scores were averaged to create a self-efficacy scale score. 30 minutes after teacher training
Secondary Acceptability of training 19-item measure of perceived acceptability of Making Proud Choices e-based facilitator training. The overall score and the three scales (System Usefulness, Information Quality, and Interface Quality) use a 7-point scale (strongly agree to strongly disagree). Higher scores equal greater acceptability/ 30 minutes after teacher training
Secondary Applicability of training 10-item measure of perceived applicability and usability of Making Proud Choices e-based facilitator training. Items were rated on a 7-point scale (strongly agree to strongly disagree), with higher scores representing greater perceptions of applicability. 30 minutes after teacher training
Secondary Overall Impression Participants overall impressions of the training were assessed using 4 item measure, rated on a 7-point Likert scale ("very difficult to use" to "very easy to use", "very boring" to "very interesting", "very amateurish" to "very professional", and "very basic" to "very informative"). Items were average to create an overall impression score, with higher scores reflecting greater overall impression. 30 minutes after teacher training
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