Adolescent BehaviorNCT03304574
CheckED Yourself Study
A study testing Integrated personalized feedback in people with Adolescent Behavior and Risk Behavior, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
During adolescence, the most common causes of morbidity and mortality are related to risky behaviors. The American Academy of Pediatrics recommends that adolescents be screened for these behaviors during primary care visits, but many adolescents do not receive the recommended risk behavior screening and counseling, in… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Risk Behavior, Motivation
- What is being tested?
- Integrated personalized feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 30 Nov 2018
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 13-18 years of age
- Ability of patient and parent of patient <18 years old to fluently speak and read English
- Has email address and/or cell phone
Who cannot join
- Inability to independently complete the assessment due to intellectual disability
- Acute cognitive impairment due to injury and/or intoxication
- Administration of IV sedation or pain medications during Emergency Department visit
- Presenting to the Emergency Department due to a psychiatric or mental health complaint
- Emergency Department visit results in hospital admission
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Lindsey Johnson, 206-884-1075, lindsey.johnson@seattlechildrens.org
Taraneh Shafii, MD, MPH
About this study
Official title: CheckED Yourself: Using Emergency Department Screening to Impact Adolescent Risk Behavior
During adolescence, the most common causes of morbidity and mortality are related to risky behaviors. The American Academy of Pediatrics recommends that adolescents be screened for these behaviors during primary care visits, but many adolescents do not receive the recommended risk behavior screening and counseling, in part because they are infrequently seen in primary care. The objective of this study is to evaluate if the electronic health screening tool, which includes an electronic health assessment with integrated personalized feedback, reduces risk behaviors in adolescents seen in the Emergency Department (ED).
Read the detailed description
Adolescents and their parents (if participant is under the age of 18 years) will be approached and invited to participate in the study during their Emergency Department (ED) visit. Following consent, adolescents will be randomized to the intervention or control group. A tablet computer will be provided to the participants for use during their baseline assessment in the ED. The CheckED Yourself App will be pre-loaded on the tablet. The CheckED Yourself App (eHA-IPF) is an innovative electronic health screening tool with integrated personalized feedback about risk behaviors. The CheckED Yourself App (eHA-IPF) will be divided into an assessment about risk behaviors and a personalized feedback portion. Participants will be randomized to a control or intervention group at the time of consent. Those in the intervention group will receive both parts of the CheckED Yourself App, while the control group will receive only the assessment with no feedback.
Those in the Intervention arm will complete the health risk behavior assessment and receive integrated personalized feedback from the CheckED Yourself App (eHA-IPF), and those in the control group will complete the health risk behavior assessment only. Participants will complete the questionnaire at some point during their ED visit and prior to discharge.
Follow-up assessments will be completed at 1-day and 3 months post ED visit via an online survey. Reminders for the 1-day and 3-month follow-ups will be sent via email or text message. The 1-day assessment will focus on adolescent-reported motivation to make a health behavior change, the content of the ED visit including what, if any, risk behaviors their ED provider discussed with the participant, and satisfaction with care in the ED. The 3-month assessment will include a re-assessment of risk behaviors.
- Conditions
- Adolescent Behavior, Risk Behavior, Motivation
- Being tested
- Integrated personalized feedback
- Medical subject headings
- Adolescent Behavior, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated personalized feedbackBehavioural
Integrated personalized feedback about self-reported risk behaviors will be generated and shown to participants as they complete their baseline health risk assessment using the CheckED Yourself app. The integrated personalized feedback is based on motivational feedback strategies such as normative feedback (comparison to peer behaviors and age-based health guidelines), increasing knowledge regarding potential consequences of behaviors, and providing practical tips for changing behavior.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will complete the electronic health assessment only and will not receive integrated personalized feedback |
| Intervention | Experimental | Participants will complete the electronic health assessment and will receive integrated personalized feedback Receives: Behavioral: Integrated personalized feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation to change
To evaluate if adolescents who received integrated personalized feedback had higher levels of motivation to change their risk behaviors post-Emergency Department visit compared to adolescents who completed the electronic health assessment only and did not receive personalized feedback
Measured: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
Decreased risk behaviors
To evaluate if adolescents who received integrated personalized feedback reported decreased risk behaviors 3 months post-Emergency Department visit compared to adolescents who completed the electronic health assessment only and did not receive personalized feedback.
Measured: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
Prevalence of risk behaviors
To describe the prevalence of risk behaviors among adolescents who present to the Emergency Department for care.
Measured: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start1 Mar 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups, a control or intervention group. Those assigned to the control group will complete the electronic health assessment only and will not receive integrated personalized feedback. Those assigned to the intervention group will complete the electronic health assessment and will receive integrated personalized feedback.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taraneh Shafii, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304574
- Sponsor's protocol ID
- 00000365
- Status last verified
- Sep 2018
- First submitted
- 3 Oct 2017
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CheckED Yourself: Using Emergency Department Screening to Impact Adolescent Risk Behavior
- ClinicalTrials.gov ID
- NCT03304574
- Acronym / sponsor ID
- 00000365
- Conditions
- Adolescent Behavior, Risk Behavior, Motivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 9 Oct 2017 (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.
During adolescence, the most common causes of morbidity and mortality are related to risky behaviors. The American Academy of Pediatrics recommends that adolescents be screened for these behaviors during primary care visits, but many adolescents do not receive the recommended risk behavior screening and counseling, in part because they are infrequently seen in primary care. The objective of this study is to evaluate if the electronic health screening tool, which includes an electronic health assessment with integrated personalized feedback, reduces risk behaviors in adolescents seen in the Emergency Department (ED).
Detailed description
Adolescents and their parents (if participant is under the age of 18 years) will be approached and invited to participate in the study during their Emergency Department (ED) visit. Following consent, adolescents will be randomized to the intervention or control group. A tablet computer will be provided to the participants for use during their baseline assessment in the ED. The CheckED Yourself App will be pre-loaded on the tablet. The CheckED Yourself App (eHA-IPF) is an innovative electronic health screening tool with integrated personalized feedback about risk behaviors. The CheckED Yourself App (eHA-IPF) will be divided into an assessment about risk behaviors and a personalized feedback portion. Participants will be randomized to a control or intervention group at the time of consent. Those in the intervention group will receive both parts of the CheckED Yourself App, while the control group will receive only the assessment with no feedback.
Those in the Intervention arm will complete the health risk behavior assessment and receive integrated personalized feedback from the CheckED Yourself App (eHA-IPF), and those in the control group will complete the health risk behavior assessment only. Participants will complete the questionnaire at some point during their ED visit and prior to discharge.
Follow-up assessments will be completed at 1-day and 3 months post ED visit via an online survey. Reminders for the 1-day and 3-month follow-ups will be sent via email or text message. The 1-day assessment will focus on adolescent-reported motivation to make a health behavior change, the content of the ED visit including what, if any, risk behaviors their ED provider discussed with the participant, and satisfaction with care in the ED. The 3-month assessment will include a re-assessment of risk behaviors.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups, a control or intervention group. Those assigned to the control group will complete the electronic health assessment only and will not receive integrated personalized feedback. Those assigned to the intervention group will complete the electronic health assessment and will receive integrated personalized feedback.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will complete the electronic health assessment only and will not receive integrated personalized feedback |
| Intervention | Experimental | Behavioral: Integrated personalized feedbackParticipants will complete the electronic health assessment and will receive integrated personalized feedback |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 13-18 years of age
- Ability of patient and parent of patient <18 years old to fluently speak and read English
- Has email address and/or cell phone
Key exclusion criteria (5 listed)
- Inability to independently complete the assessment due to intellectual disability
- Acute cognitive impairment due to injury and/or intoxication
- Administration of IV sedation or pain medications during Emergency Department visit
- Presenting to the Emergency Department due to a psychiatric or mental health complaint
- Emergency Department visit results in hospital admission
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 |
|---|---|---|
| Integrated personalized feedbackIntegrated personalized feedback about self-reported risk behaviors will be generated and shown to participants as they complete their baseline health risk assessment using the CheckED Yourself app. The integrated personalized feedback is based on motivational feedback strategies such as normative feedback (comparison to peer behaviors and age-based health guidelines), increasing knowledge regarding potential consequences of behaviors, and providing practical tips for changing behavior. | Behavioural | Intervention |
Primary outcome
Motivation to change
Time frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
To evaluate if adolescents who received integrated personalized feedback had higher levels of motivation to change their risk behaviors post-Emergency Department visit compared to adolescents who completed the electronic health assessment only and did not receive personalized feedback
Decreased risk behaviors
Time frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
To evaluate if adolescents who received integrated personalized feedback reported decreased risk behaviors 3 months post-Emergency Department visit compared to adolescents who completed the electronic health assessment only and did not receive personalized feedback.
Prevalence of risk behaviors
Time frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
To describe the prevalence of risk behaviors among adolescents who present to the Emergency Department for care.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: No. N/A IPD will not be shared
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated personalized feedback in people with Adolescent Behavior and Risk Behavior, run by Seattle Children's 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taraneh Shafii, MD, MPH (206-987-2028, taraneh.shafii@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation to change (time frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.). The study lists 3 primary outcomes in all. 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 Sep 2018.