Mental DisordersNCT02680899
Adolescent Mental Health InSciEd Out
A study testing Curricular Intervention in people with Mental Disorders and Substance-Related Disorders, run by Mayo Clinic at 1 site in United States.
Trial summary
The study herein seeks to determine whether students undergoing InSciEd Out curriculum in mental health and addiction (called My Mind, My Body) experience changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders, Substance-Related Disorders, Social Stigma
- What is being tested?
- Curricular Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to May 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Inclusion Criteria: Partner school students who do not opt out of and assent to the study
Exclusion Criteria: Partner school students opting out of or not assenting to the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Adolescent Outcomes in Mental Health InSciEd Out
The study herein seeks to determine whether students undergoing InSciEd Out curriculum in mental health and addiction (called My Mind, My Body) experience changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. The research group hypothesizes that students undergoing InSciEd Out mental health and addiction curriculum will exhibit pre-post increases in mental health literacy, decreases in mental health stigmatization, and increases in mental health help-seeking behavioral intentions.
Read the detailed description
Integrated Science Education Outreach (InSciEd Out) is one novel program that seeks to promote scientific and health literacy through fostering scientific inquiry. The guiding premise of InSciEd Out's health promotion arm is a concept called Prescription Education (PE), which uses science education as a direct and early intervention for disease behaviors. The underlying hypothesis of InSciEd Out PE is that a student who lives a scientific experience in his or her own voice (undergoes true inquiry-based science) will be empowered to elect healthier behaviors in any targeted health paradigm. PE's proposed mechanism of change is that inquiry-based science catalyzes transitions from knowledge to understanding to attitudes to intents to actual behavioral change.
InSciEd Out partnership with the the school in this study began in Spring of 2013 with a projected health promotion arm targeting mental health and addiction. The current iteration of the partnership commenced in Summer of 2014 under the annual InSciEd Out summer internship. This internship led to creation of grades 7 and 8 curriculum in mental health and addiction. Version 1 of this curriculum was piloted last year. A revised version of the curriculum will be implemented in Spring of 2016. Although there are education-specific metrics for assessment already built into program evaluation of InSciEd Out, there are currently no clinically relevant inventories in place to specifically probe efficacy of the lesson plans upon key mental health outcomes.
The study herein is the establishment of clinically relevant inventories around implemented InSciEd Out curriculum in mental health and addiction (called My Mind, My Body). These inventories are selected to measure student changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. The research group hypothesizes that students undergoing InSciEd Out mental health and addiction curriculum will exhibit pre-post increases in mental health literacy, decreases in mental health stigmatization, and increases in mental health help-seeking behavioral intentions.
- Conditions
- Mental Disorders, Substance-Related Disorders, Social Stigma, Mental Health Wellness 1, Mental Health Impairment
- Being tested
- Curricular Intervention
- Keywords
- science education, health promotion, mental health promotion, stigmatization, behavioral intervention
- Medical subject headings
- Mental Disorders, Substance-Related Disorders, Social Stigma, Stereotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curricular InterventionBehavioural
The intervention is a novel grades 7 and 8 InSciEd Out curriculum in mental health and addiction called My Mind, My Body.
| Study group | Role | What they receive |
|---|---|---|
| Curricular Intervention | Experimental | The intervention is a novel science education curriculum in mental health and addiction called My Mind, My Body. Receives: Behavioral: Curricular Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Score on General Help-Seeking Questionnaire at 1 month
The general help-seeking questionnaire: vignette version (GHSQ-V) will be used to assess help-seeking behavioral intentions.
Measured: Baseline and then at study completion, estimated to be ~1 month
Change from Baseline Score on Westbrook Mental Health Knowledge Test at 1 month
The Westbrook Knowledge Test assesses mental health knowledge.
Measured: Baseline and then at study completion, estimated to be ~1 month
Change from Baseline Score on Adolescent Attribution Questionnaire at 1 month
The adolescent attribution questionnaire (AQ-8-C) will be used to assess mental illness stigmatization.
Measured: Baseline and then at study completion, estimated to be ~1 month
Secondary outcomes (1)
Teacher Report of Student Outcomes
Teacher quotes from semi-structured interviews concerning student outcomes in mental health knowledge, attitudes, and behaviors will be used to form a student narrative.
Measured: Conducted at study completion, estimated to be ~1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Pierret, Mayo Clinic
- Investigators
- Christopher Pierret, PhD, Principal investigator, Mayo ClinicStephen C Ekker, PhD, Principal investigator, Mayo ClinicJoanna Yang, BS, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680899
- Sponsor's protocol ID
- 15-009107
- Status last verified
- Nov 2017
- First submitted
- 2 Feb 2016
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yang J, Lopez Cervera R, Tye SJ, Ekker SC, Pierret C. Adolescent mental health education InSciEd Out: a case study of an alternative middle school population. J Transl Med. 2018 Apr 3;16(1):84. doi: 10.1186/s12967-018-1459-x.
PubMed 29615090
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Outcomes in Mental Health InSciEd Out
- ClinicalTrials.gov ID
- NCT02680899
- Acronym / sponsor ID
- 15-009107
- Conditions
- Mental Disorders, Substance-Related Disorders, Social Stigma, Mental Health Wellness 1, Mental Health Impairment
- Keywords
- science education, health promotion, mental health promotion, stigmatization, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 Feb 2016 (estimated)
- 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.
The study herein seeks to determine whether students undergoing InSciEd Out curriculum in mental health and addiction (called My Mind, My Body) experience changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. The research group hypothesizes that students undergoing InSciEd Out mental health and addiction curriculum will exhibit pre-post increases in mental health literacy, decreases in mental health stigmatization, and increases in mental health help-seeking behavioral intentions.
Detailed description
Integrated Science Education Outreach (InSciEd Out) is one novel program that seeks to promote scientific and health literacy through fostering scientific inquiry. The guiding premise of InSciEd Out's health promotion arm is a concept called Prescription Education (PE), which uses science education as a direct and early intervention for disease behaviors. The underlying hypothesis of InSciEd Out PE is that a student who lives a scientific experience in his or her own voice (undergoes true inquiry-based science) will be empowered to elect healthier behaviors in any targeted health paradigm. PE's proposed mechanism of change is that inquiry-based science catalyzes transitions from knowledge to understanding to attitudes to intents to actual behavioral change.
InSciEd Out partnership with the the school in this study began in Spring of 2013 with a projected health promotion arm targeting mental health and addiction. The current iteration of the partnership commenced in Summer of 2014 under the annual InSciEd Out summer internship. This internship led to creation of grades 7 and 8 curriculum in mental health and addiction. Version 1 of this curriculum was piloted last year. A revised version of the curriculum will be implemented in Spring of 2016. Although there are education-specific metrics for assessment already built into program evaluation of InSciEd Out, there are currently no clinically relevant inventories in place to specifically probe efficacy of the lesson plans upon key mental health outcomes.
The study herein is the establishment of clinically relevant inventories around implemented InSciEd Out curriculum in mental health and addiction (called My Mind, My Body). These inventories are selected to measure student changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. The research group hypothesizes that students undergoing InSciEd Out mental health and addiction curriculum will exhibit pre-post increases in mental health literacy, decreases in mental health stigmatization, and increases in mental health help-seeking behavioral intentions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curricular Intervention | Experimental | Behavioral: Curricular InterventionThe intervention is a novel science education curriculum in mental health and addiction called My Mind, My Body. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Curricular InterventionThe intervention is a novel grades 7 and 8 InSciEd Out curriculum in mental health and addiction called My Mind, My Body. | Behavioural | Curricular Intervention |
Primary outcome
Change from Baseline Score on General Help-Seeking Questionnaire at 1 month
Time frame: Baseline and then at study completion, estimated to be ~1 month
The general help-seeking questionnaire: vignette version (GHSQ-V) will be used to assess help-seeking behavioral intentions.
Change from Baseline Score on Westbrook Mental Health Knowledge Test at 1 month
Time frame: Baseline and then at study completion, estimated to be ~1 month
The Westbrook Knowledge Test assesses mental health knowledge.
Change from Baseline Score on Adolescent Attribution Questionnaire at 1 month
Time frame: Baseline and then at study completion, estimated to be ~1 month
The adolescent attribution questionnaire (AQ-8-C) will be used to assess mental illness stigmatization.
1 secondary outcome
Teacher Report of Student Outcomes
Time frame: Conducted at study completion, estimated to be ~1 month
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 30 Nov 2017.
- Derived from this study: PubMed 29615090Yang J, Lopez Cervera R, Tye SJ, Ekker SC, Pierret C. Adolescent mental health education InSciEd Out: a case study of an alternative middle school population. J Transl Med. 2018 Apr 3;16(1):84. doi: 10.1186/s12967-018-1459-x.
- Individual participant dataSharing planned: No
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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.
Christopher Pierret, PhD principal investigator
Mayo Clinic
Stephen C Ekker, PhD principal investigator
Mayo Clinic
Joanna Yang, BS study director
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curricular Intervention in people with Mental Disorders and Substance-Related Disorders, run by Mayo Clinic 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?
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 Nov 2017. 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?
Change from Baseline Score on General Help-Seeking Questionnaire at 1 month (time frame: Baseline and then at study completion, estimated to be ~1 month). 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?
On the ClinicalTrials.gov record for NCT02680899, 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 Nov 2017.