Risk BehaviorNCT03430570
An Emotion Regulation Intervention for Early Adolescent Risk Prevention
A study testing Tablet TRAC Emotion Regulation Intervention in people with Risk Behavior and Risk Reduction, run by Rhode Island Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Behavior, Risk Reduction, Emotion Regulation
- What is being tested?
- Tablet TRAC Emotion Regulation Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2019to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- attending the seventh grade at a participating school
- being between the ages of 12 and 14
Who cannot join
- those who cannot read English at a 4th grade level
- those with developmental delays
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital- Bradley Hasbro Children's Research Center
Providence, Rhode Island, 02903
About this study
Official title: An Emotion Regulation Intervention for Early Adolescent Risk Behavior Prevention
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.
Read the 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
- Being tested
- Tablet TRAC Emotion Regulation Intervention
- Keywords
- Adolescent risk behavior, digital, early adolescence, emotion regulation, prevention
- Medical subject headings
- Risk-Taking, Risk Reduction Behavior, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet TRAC Emotion Regulation InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tablet TRAC Emotion Regulation Intervention | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Nonacceptance of emotional response (6 items)
- Difficulties engaging in goal directed behavior [goals] (5 items)
- Impulse control difficulties [impulse] (6 items)
- Lack of emotion awareness [awareness] (6 items)
- Limited access to emotion regulation strategies [strategies] (8 items)
- 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)
Measured: baseline- 3 month follow up
Secondary outcomes (8)
Emotion Recognition/DANVA
Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2) is a computer-based measure that asks participants to identify the emotion of facial expressions displayed in a series of 24 photographs and in 24 oral presentations of a neutral sentence, with higher scores indicating higher accuracy of emotion recognition. Total possible range = 0-48.
Measured: Baseline-3 month follow up
Emotion Regulation/Emotion Regulation Checklist
The Emotion Regulation Checklist contains 24 items on a 4-point Likert scale (1=never through 4= almost always; Total Range: 15-360). Parents rate 24 behavioral descriptions, yielding 2 subscales: 1) Lability/Negativity (α= .95), and 2) Emotion Regulation (α=.84). The Emotion Regulation subscale contains 8 items, while the Lability/Negativity scale contains 15 items. Higher scores on the Lability/Negativity scale indicate higher inflexibility, emotional reactivity, and dysregulated negative affect; higher scores on the emotion regulation subscale indicate greater situationally appropriate affective displays, empathy, and emotional self-awareness (Shields \& Cicchetti, 1997). Alphas for the subscales are good (L/N α = .96; ER α = .83). One single measurement of emotion regulation is generated from the overall scores in both sub-scales (α = .89; Shields \& Cicchetti, 1997).
Measured: baseline-3 month follow up
Emotion Regulation/ The Regulation of Emotions Questionnaire
The Regulation of Emotions Questionnaire* (21 items) assesses frequency of use of both functional and dysfunctional emotion regulation strategies (α= >.66). Participants rate their responses on a 5-point Likert scale from 1- "never" through 5- "always". (Total Range: 21-110). Higher scores indicate higher frequency of use of emotion regulation strategies.
Measured: baseline-3 month follow up
Emotion Regulation/Self Efficacy Questionnaire for Children
The Emotional Self-efficacy subscale of the Self-Efficacy Questionnaire for Children (8 items) assesses perception of one's ability to cope with negative emotions (α= .83). It has been shown to be valid, reliable, and related to risk behaviors among US adolescents. Subjects rate their responses on a 5-point Likert scale from 1 "not at all" through 5 "very well". (Range: 8-40, with lower scores indicating low perception of ability to cope with negative emotions).
Measured: baseline-3 month follow-up
Emotion Regulation/Emotion Regulation Behavior Scale
The Emotion Regulation Behaviors Scale (8 items) measures use of the specific emotion regulation strategies taught in Project TRAC (α= .73). Participants respond on a scale of 1 (never) to 5 (all the time) across 8 items, with higher scores indicating more regulatory behaviors (range: 8-40).
Measured: baseline-3 month follow up
Emotion Regulation/Affect Dysregulation Scale
The Affect Dysregulation Scale contains 6 items used to assess frequency of difficulty with affect regulation on 4-point Likert scale from 1=not at all to 4=often (α= .72), with higher scores indicating more difficulty managing feelings. affect (range: 6-36).
Measured: baseline-3 month follow up
Assessment Risk Behavior/Youth Risk Behavior Surveillance System
7 items taken from the Center for Disease Control's Youth Risk Behavior Surveillance System will be used to assess adolescents' engagement in substance use, violence, and other risk behaviors. Participants will be asked risk behavior questions similar to the following item: "During the past 30 days, on how many days did you smoke cigarettes?" with answer choices ranging from 0, 1-2, 3-5, 6-9, 10-19, 20-29, 30.
Measured: Baseline-3 month follow up
Distress Tolerance
Behavioral Indicator of Resiliency to Distress (BIRD) and Mirror Tracing Persistence Task (MTPT) are 5-minute computerized distress tolerance tasks that generate a score of time spent persisting on a dysregulating task that provides negative feedback (aversive noise) when users do not succeed at very challenging tasks, with more time spent on the tasks indicating greater distress tolerance. Possible range = 0-300 seconds.
Measured: baseline-3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start19 Feb 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to complete a computerized intervention or a wait list control.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Christopher Houck, PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430570
- Sponsor's protocol ID
- R21HD089979
- Other IDs
- R21HD089979
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2018
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After analyses are completed for the aims of the study, deidentified databases will be made available to qualified researchers through standard data sharing procedures.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Emotion Regulation Intervention for Early Adolescent Risk Behavior Prevention
- ClinicalTrials.gov ID
- NCT03430570
- Acronym / sponsor ID
- R21HD089979
- Conditions
- Risk Behavior, Risk Reduction, Emotion Regulation
- Keywords
- Adolescent risk behavior, digital, early adolescence, emotion regulation, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to complete a computerized intervention or a wait list control.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- attending the seventh grade at a participating school
- being between the ages of 12 and 14
Key exclusion criteria (2 listed)
- those who cannot read English at a 4th grade level
- those with developmental delays
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet TRAC Emotion Regulation InterventionThe 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. | Behavioural | Tablet TRAC Emotion Regulation Intervention |
Primary outcome
Emotion Regulation/Difficulties in Emotion Regulation Scale
Time frame: baseline- 3 month follow up
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)
8 secondary outcomes
Emotion Recognition/DANVA
Time frame: Baseline-3 month follow up
Emotion Regulation/Emotion Regulation Checklist
Time frame: baseline-3 month follow up
Emotion Regulation/ The Regulation of Emotions Questionnaire
Time frame: baseline-3 month follow up
Emotion Regulation/Self Efficacy Questionnaire for Children
Time frame: baseline-3 month follow-up
Emotion Regulation/Emotion Regulation Behavior Scale
Time frame: baseline-3 month follow up
Emotion Regulation/Affect Dysregulation Scale
Time frame: baseline-3 month follow up
Assessment Risk Behavior/Youth Risk Behavior Surveillance System
Time frame: Baseline-3 month follow up
Distress Tolerance
Time frame: baseline-3 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Individual participant dataSharing planned: Yes. After analyses are completed for the aims of the study, deidentified databases will be made available to qualified researchers through standard data sharing procedures.
Related trials for Risk Behavior
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Houck, PhD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet TRAC Emotion Regulation Intervention in people with Risk Behavior and Risk Reduction, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Regulation/Difficulties in Emotion Regulation Scale (time frame: baseline- 3 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.