Clinical trial NCT03430570: An Emotion Regulation Intervention for Early Adolescent Risk Prevention
Official title: An Emotion Regulation Intervention for Early Adolescent Risk Behavior Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Behavior
Risk Reduction
Emotion Regulation
Keywords: Adolescent risk behavior
digital
early adolescence
emotion regulation
prevention
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-02-13
Enrollment: 85
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to complete a computerized intervention or a wait list control.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Emotion Regulation/Difficulties in Emotion Regulation Scale
timeFrame: baseline- 3 month follow up
Secondary outcomes:
measure: Emotion Recognition/DANVA
timeFrame: Baseline-3 month follow up
measure: Emotion Regulation/Emotion Regulation Checklist
timeFrame: baseline-3 month follow up
measure: Emotion Regulation/ The Regulation of Emotions Questionnaire
timeFrame: baseline-3 month follow up
measure: Emotion Regulation/Self Efficacy Questionnaire for Children
timeFrame: baseline-3 month follow-up
measure: Emotion Regulation/Emotion Regulation Behavior Scale
timeFrame: baseline-3 month follow up
measure: Emotion Regulation/Affect Dysregulation Scale
timeFrame: baseline-3 month follow up
measure: Assessment Risk Behavior/Youth Risk Behavior Surveillance System
timeFrame: Baseline-3 month follow up
measure: Distress Tolerance
timeFrame: baseline-3 month follow up
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital- Bradley Hasbro Children's Research Center
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Christopher Houck, PhD
role: PRINCIPAL_INVESTIGATOR
References: