An Emotion Regulation Intervention for Early Adolescent Risk Prevention

NCT ID: NCT03430570

Last Updated: 2019-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-19
• Study Completion Date: 2019-10-31

Brief Summary

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.

Detailed Description

Emotion regulation in adolescence is associated with health risk behaviors, including sex and substance use, and early onset of these behaviors represents a risk factor for negative health outcomes throughout life. Thus, interventions appropriate for early adolescence, when these behaviors commonly begin, are critical for prevention efforts. The research team has developed and tested a novel, engaging, and efficacious intervention that addresses emotion regulation, a theoretically important and under-researched factor associated with risk. The efficacy trial of this intervention, Project TRAC, showed that an intervention strategy using emotion regulation was significantly more successful than an active comparison condition on the primary target, delaying onset of sexual activity over a two and a half year follow-up, as well as on other risk behaviors, such as condom use, fighting, and partner violence. While efficacious, the current face-to-face, small group format of the program is a difficult model to sustain and implement on a larger scale. With a long-term goal toward dissemination, this two-year project will translate the emotion regulation components of this successful program for tablet-based delivery to enable it to reach a large audience in a format that can be related to a variety of health behavior education topics (e.g., sexual health, violence, substance use). For the proposed project, the Rhode Island Hospital/ Brown University research team will collaborate with Klein Buendel, a health communications technology company, to translate the emotion regulation content of Project TRAC for tablet computers. This translation, using well-established theoretical frameworks, will be approached in consultation with members of the target population (early adolescents) and experts in the field. After the intervention has been translated to a tablet form, ten adolescents will test the program to assess acceptability and usability. Finally, a small pilot study (n=100) will assess feasibility of the translated intervention and compare it to a waitlist control group.

Conditions

Risk Behavior; Risk Reduction; Emotion Regulation

Keywords

Adolescent risk behavior; digital; early adolescence; emotion regulation; prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Tablet TRAC Emotion Regulation Intervention

Group Type: EXPERIMENTAL

Tablet TRAC Emotion Regulation Intervention

Intervention Type: BEHAVIORAL

The intervention focuses on developmentally appropriate strategies for emotion regulation during difficult situations, particularly those related to risk, using 3 primary groups of strategies identified during qualitative work in Project TRAC (R34 MH078750): 1) getting away (physically or cognitively) from triggers for strong emotions, 2) releasing emotional energy in healthy ways (physically or verbally) or 3) changing cognitions and appraisals about emotional triggers. Using strategies effective in TRAC, teens will engage in games to practice and apply strategies to risk scenarios, as well as personalize content learned.

Waitlist Control

Control participants are assessed on the same schedule as the treatment condition and offered the intervention after the 3-month follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tablet TRAC Emotion Regulation Intervention

The intervention focuses on developmentally appropriate strategies for emotion regulation during difficult situations, particularly those related to risk, using 3 primary groups of strategies identified during qualitative work in Project TRAC (R34 MH078750): 1) getting away (physically or cognitively) from triggers for strong emotions, 2) releasing emotional energy in healthy ways (physically or verbally) or 3) changing cognitions and appraisals about emotional triggers. Using strategies effective in TRAC, teens will engage in games to practice and apply strategies to risk scenarios, as well as personalize content learned.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• attending the seventh grade at a participating school
• being between the ages of 12 and 14

Exclusion Criteria

• those who cannot read English at a 4th grade level
• those with developmental delays

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Houck, PhD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Rhode Island Hospital- Bradley Hasbro Children's Research Center

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

R21HD089979

Identifier Type: NIH

Identifier Source: secondary_id

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R21HD089979

Identifier Type: NIH

Identifier Source: org_study_id

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