NCT03430570

An Emotion Regulation Intervention for Early Adolescent Risk Prevention

Completed NA Last updated 6 December 2019

What this trial tests

NA trial testing Tablet TRAC Emotion Regulation Intervention in Risk Behavior in 85 participants. Completed in 31 October 2019.

Timeline

19 February 2019

Primary endpoint
31 October 2019

31 October 2019

Quick facts

Lead sponsor	Rhode Island Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	85
Start date	19 February 2019
Primary completion	31 October 2019
Estimated completion	31 October 2019
Sites	1 location across United States

Drugs / interventions tested

• Tablet TRAC Emotion Regulation Intervention

Conditions studied

• Risk Behavior — all drugs for Risk Behavior →
• Risk Reduction — all drugs for Risk Reduction →
• Emotion Regulation — all drugs for Emotion Regulation →

Sponsor

Rhode Island Hospital

Who can join

Adults 12 to 14, any sex, with Risk Behavior or Risk Reduction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will take a group-based intervention for adolescents that reduced sexual risk behavior and create a computer-based version, which is a format that adolescents like and that is more cost-effective. The intervention focuses on teaching adolescents skills for managing their emotions when they are making decisions that could put them at risk (like whether to have sex or drink alcohol). The investigators are hoping to learn whether a computer version of the program will be useful in helping adolescents learn about emotional competence and reducing risky behaviors. The investigators will make a version of the intervention as games on tablet computers in a partnership with a technology company, Klein Buendel. The research team will begin by getting advice from adolescents and experts (in separate groups) about how to convey the ideas from the group program into computer games. Klein Buendel will then create the games. Then, about 10 adolescents will be asked to try out the program and give us feedback about things to change. Klein Buendel will make those changes. Then the investigators will ask about 100 adolescents to volunteer to be randomly placed in one of two groups. One group will do the computer program right away; the other will wait for three months. Both groups will be asked to answer questions and do computer tasks when the team meets them, one month later, and three months later. The investigators will compare the groups to see if the group that received the computer intervention reports being more emotionally competent than the group that has not yet done the computer intervention. The research team will also ask them about their risk behaviors. If this is useful, it may be a good way to enhance health education taught in schools.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.