Depression Anxiety and Co-occurring Rural YouthNCT04928001
Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings
A study testing internet based iCBT program, Youth Thrive in people with Depression Anxiety and Co-occurring Rural Youth, run by Montana State University at 1 site in United States.
Trial summary
This research study examines rural youth's experience of an internet based cognitive behavioral therapy intervention, and their experience of symptoms of depression, anxiety and co-occurring disorders. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression Anxiety and Co-occurring Rural Youth
- What is being tested?
- internet based iCBT program, Youth Thrive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to 9 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- participants are youth enrolled in participating schools
- ages 13 - 18 years old
- have access to electronic device to access iCBT intervention
Who cannot join
- none.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study for Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings and Its Impact on Adolescent Mental and Behavioral Health
This research study examines rural youth's experience of an internet based cognitive behavioral therapy intervention, and their experience of symptoms of depression, anxiety and co-occurring disorders.
Read the detailed description
In the United States, and rural Montana, a substantial health disparity exists for rural youths' mental health and mental health care access. In 2017, nearly a third of all Montana high school students reported being impacted by depression; 21% considered suicide compared to 17% nationally. Over 30% of Montana adolescents indicated drinking alcohol and 20% indicated using marijuana. Rural Montanans face enormous barriers to behavioral health care including low mental health care provider coverage, long distances to adequate care, and stigma. We have developed a culturally and developmentally appropriate Internet-based Cognitive Behavior Therapy (iCBT) program designed to teach skills that address mental and behavioral health challenges common to adolescents. Building on previous development and evaluation of an adult version of iCBT (Thrive), the investigators propose to pilot the newly developed youth version of Thrive (Y-T), a fully automated stand-alone program. Y-T will deliver CBT skills through educational, real life adolescent scenarios, and tailored feedback videos to address symptoms of depression, anxiety and co-occurring (addiction) behaviors. The investigators intend to conduct feasibility analyses of pilot study implementation in school communities. The investigators will document and assess organization-level facilitators and barriers that impact the study processes at each study site. Short-term goal for this research are to understand how to effectively conduct trials within school community settings and to obtain preliminary information on the acceptability and effectiveness of the Y-T program to address depression and anxiety symptoms, and addictive behaviors. The investigators will conduct post-intervention focus groups to assess the program as experienced by participants and insight on the extent of program engagement and learning. The investigators hypothesize that those using Y-T over an 8-week period will report markedly decreased scores on anxiety, depression, and addictive behaviors. The long-term goal is to conduct a larger trial of the program to determine the evidence of impact among youth. Provided that this research demonstrates such programs to be evidence-based, the investigators will work on a broader dissemination plan with the ultimate aim of decreasing mental and behavioral health and respective health care disparities among rural youth.
- Being tested
- internet based iCBT program, Youth Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet based iCBT program, Youth ThriveOther
iCBT program is a skills program which teaches assertive communication, constructive thinking and rewarding activities
| Study group | Role | What they receive |
|---|---|---|
| Youth Thrive iCBT program | Other | Youth Thrive iCBT online program Receives: Other: internet based iCBT program, Youth Thrive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck's Anxiety Inventory, Youth Version
The inventory measures anxiety symptoms and utilizes T Scores. 52.45 indicates the population mean with a standard deviation of 11.4 55 or less minimal, average symptoms of anxiety 55-59 mild symptoms of anxiety 60-69 moderate symptoms of anxiety 70+ severe symptoms of anxiety
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start17 Feb 2021
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression Anxiety and Co-occurring Rural YouthStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- multiple baseline pre-post design
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Franklin, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928001
- Sponsor's protocol ID
- KF072420
- Status last verified
- Dec 2024
- First submitted
- 9 Jun 2021
- Last updated
- 30 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franklin K, Tribbit T. A Feasibility Study for Implementing and Evaluating an Internet-Based Cognitive Behavior Therapy Intervention in Rural School Settings and its Impact on Adolescent Mental and Behavioral Health. Chronicle of Rural Education. 2024; 2(1).
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings and Its Impact on Adolescent Mental and Behavioral Health
- ClinicalTrials.gov ID
- NCT04928001
- Acronym / sponsor ID
- KF072420
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Posted 30 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study examines rural youth's experience of an internet based cognitive behavioral therapy intervention, and their experience of symptoms of depression, anxiety and co-occurring disorders.
Detailed description
In the United States, and rural Montana, a substantial health disparity exists for rural youths' mental health and mental health care access. In 2017, nearly a third of all Montana high school students reported being impacted by depression; 21% considered suicide compared to 17% nationally. Over 30% of Montana adolescents indicated drinking alcohol and 20% indicated using marijuana. Rural Montanans face enormous barriers to behavioral health care including low mental health care provider coverage, long distances to adequate care, and stigma. We have developed a culturally and developmentally appropriate Internet-based Cognitive Behavior Therapy (iCBT) program designed to teach skills that address mental and behavioral health challenges common to adolescents. Building on previous development and evaluation of an adult version of iCBT (Thrive), the investigators propose to pilot the newly developed youth version of Thrive (Y-T), a fully automated stand-alone program. Y-T will deliver CBT skills through educational, real life adolescent scenarios, and tailored feedback videos to address symptoms of depression, anxiety and co-occurring (addiction) behaviors. The investigators intend to conduct feasibility analyses of pilot study implementation in school communities. The investigators will document and assess organization-level facilitators and barriers that impact the study processes at each study site. Short-term goal for this research are to understand how to effectively conduct trials within school community settings and to obtain preliminary information on the acceptability and effectiveness of the Y-T program to address depression and anxiety symptoms, and addictive behaviors. The investigators will conduct post-intervention focus groups to assess the program as experienced by participants and insight on the extent of program engagement and learning. The investigators hypothesize that those using Y-T over an 8-week period will report markedly decreased scores on anxiety, depression, and addictive behaviors. The long-term goal is to conduct a larger trial of the program to determine the evidence of impact among youth. Provided that this research demonstrates such programs to be evidence-based, the investigators will work on a broader dissemination plan with the ultimate aim of decreasing mental and behavioral health and respective health care disparities among rural youth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multiple baseline pre-post design
| Arm | Type | Receives |
|---|---|---|
| Youth Thrive iCBT program | Other | Other: internet based iCBT program, Youth ThriveYouth Thrive iCBT online program |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- participants are youth enrolled in participating schools
- ages 13 - 18 years old
- have access to electronic device to access iCBT intervention
Key exclusion criteria (1 listed)
- none.
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 |
|---|---|---|
| internet based iCBT program, Youth ThriveiCBT program is a skills program which teaches assertive communication, constructive thinking and rewarding activities | Other | Youth Thrive iCBT program |
Primary outcome
Beck's Anxiety Inventory, Youth Version
Time frame: 8 weeks
The inventory measures anxiety symptoms and utilizes T Scores. 52.45 indicates the population mean with a standard deviation of 11.4 55 or less minimal, average symptoms of anxiety 55-59 mild symptoms of anxiety 60-69 moderate symptoms of anxiety 70+ severe symptoms of anxiety
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationFranklin K, Tribbit T. A Feasibility Study for Implementing and Evaluating an Internet-Based Cognitive Behavior Therapy Intervention in Rural School Settings and its Impact on Adolescent Mental and Behavioral Health. Chronicle of Rural Education. 2024; 2(1).
- Link to published article and resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internet based iCBT program, Youth Thrive in people with Depression Anxiety and Co-occurring Rural Youth, run by Montana State University 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 1 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 30 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Beck's Anxiety Inventory, Youth Version (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04928001, which also lists 1 linked publication.
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 30 Jan 2025.