An Emotion Regulation Intervention for Early Adolescent Risk Prevention

NCT03430570 | Completed

• 1 other identifier: R21HD089979
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Risk Behavior; Risk Reduction; Emotion Regulation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Emotion Regulation/Difficulties in Emotion Regulation Scale

  Difficulties in Emotion Regulation Scale- The Difficulties in Emotion Regulation Scale (36 items) uses 6 subscales (all α \> .80) to assess perceptions of skill in ER, awareness, and impulse control based on Linehan's theoretical work. The six subscales are: 1. Nonacceptance of emotional response (6 items) 2. Difficulties engaging in goal directed behavior \[goals\] (5 items) 3. Impulse control difficulties \[impulse\] (6 items) 4. Lack of emotion awareness \[awareness\] (6 items) 5. Limited access to emotion regulation strategies \[strategies\] (8 items) 6. Lack of emotional clarity \[clarity\]. (5 items) Participants rate their responses on a 5-point Likert scale ranging from 1 (almost never)- 5 (almost always). The total score is calculated from the sum of all the items, with higher scores indicating greater problems with emotion regulation. (Total possible range: 36-180)

  baseline- 3 month follow up

Secondary Outcomes (8)

• Emotion Recognition/DANVA

  Baseline-3 month follow up

• Emotion Regulation/Emotion Regulation Checklist

  baseline-3 month follow up

• Emotion Regulation/ The Regulation of Emotions Questionnaire

  baseline-3 month follow up

• Emotion Regulation/Self Efficacy Questionnaire for Children

  baseline-3 month follow-up

• Emotion Regulation/Emotion Regulation Behavior Scale

  baseline-3 month follow up

Study Arms (2)

Tablet TRAC Emotion Regulation Intervention

EXPERIMENTAL

Behavioral: Tablet TRAC Emotion Regulation Intervention

Waitlist Control

NO INTERVENTION

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

Interventions

Tablet TRAC Emotion Regulation Intervention 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.

Tablet TRAC Emotion Regulation Intervention

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Rhode Island Hospital- Bradley Hasbro Children's Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Risk-Taking; Risk Reduction Behavior; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavior; Self-Control; Social Behavior

Study Officials

• Christopher Houck, PhD

  Rhode Island Hospital

  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 will be randomized to complete a computerized intervention or a wait list control.

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: February 19, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: December 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)