PsychoeducationNCT04170868
Psychoeducational Video Series - Proof of Concept
A study testing ADHD Psycheducation in people with Psychoeducation, run by McMaster University.
Trial summary
The purpose of this study is to produce and then assess a psychoeducational video series intended for use amongst an adult attention deficit/hyperactive clinical population. The videos will disseminate evidence-based strategies for the management of Attention Deficit Hyperactivity Disorder (ADHD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychoeducation
- What is being tested?
- ADHD Psycheducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Nov 2019to 1 Apr 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and up
- Ability to fill out a computerized form
- Ability to access the Internet
- Ability/Willingness to watch several psychoeducational videos
- Ability/Willingness to understand and abide by the procedures and the acknowledge disclosure statement
- The participants in the ADHD group must be diagnosed by a psychiatrist. Diagnosis will be confirmed by re-evaluation using the Adult ADHD Self-Report Scale (ASRS)
Who cannot join
- Under 18 years of age
- Inability to fill out a computerized form
- Does not currently have Internet access
- Inability/Unwillingness to watch several psychoeducational videos
- Inability/Unwillingness to understand and abide by the procedures and acknowledge disclosure statement
- The participant has not been diagnosed with ADHD by a psychiatrist. Or, the diagnosis does not meet confirmation following re-evaluation using the Adult ADHD Self-Report Scale (ASRS)
About this study
The purpose of this study is to produce and then assess a psychoeducational video series intended for use amongst an adult attention deficit/hyperactive clinical population. The videos will disseminate evidence-based strategies for the management of Attention Deficit Hyperactivity Disorder (ADHD). Each video, roughly two minutes, will both introduce the viewer to a single ADHD management strategy and explain how said strategy can effectively be applied. The collective of the finished video series will aim to cover the breadth of common ADHD-related issues. An example of the animated video styling can be found at the following link: bit.ly/ADHD_Ethics. The investigators will evaluate these videos in a proof of concept program, looking at outcomes in both functional skill development and patient perspective. The results will be presented in an undergraduate thesis presentation.
Read the detailed description
The study will consist of four phases, each involving the completion of several self-report metrics following video exposure or the lack thereof. The investigators expect 30-40 patients to progress through a quadriphasic design.
Phase 1:
Upon understanding and signing an informed consent form, participants will complete a short demographics questionnaire that will enquire into their age, education level, and gender, but will not include specific identifying information such as name, initials, email, or home address.
Next, participants will be asked to complete a survey containing both the Tuckman Condensed Procrastination Scale (TCPS) and the Adult ADHD Self-Report Scale (ASRS). The data that are gathered from the ASRS will be used as a core inclusion-exclusion metric.
Finally, participants will be briefed on the video access system and then given their unique login credentials, which allow the investigators to track individual usage metrics. The investigators will then explain that for the next ten days the participant will have unlimited access to a single, randomly assigned experimental video (with participants split between one of two videos) adding that at the third and seventh days the participant will receive-pending consent-a friendly email reminder of their ability to access the video. Any questions will be addressed at this point.
All in, the time required to complete Phase 1 for a single participant will be 30-45 minutes.
Phase 2:
After ten days have elapsed, the participant will be sent an online survey link containing the TCPS, ASRS, and a Video Review Survey. The email will also explain how video access over the upcoming ten days will be restricted-as Phase 3 of the study commences-but that they need not worry as full-access will be reinstated following completion of the study. With that, participants will be reminded of the investigator's contact information and left to continue using the learned strategies for the upcoming ten days.
Phase 3:
Following the ten day washout period, participants will be sent another online survey link containing the TCPS and ASRS. The email will also contain access to the second of the two videos, along with a re-explanation of how the investigators hope they use it. From here, another ten-day exposure period will begin.
Phase 4:
After completing the second ten-day exposure period (totalling one month's time), the participant will be asked to answer a final Future Video Survey. Once the survey has been answered, the participant will have finished the study and will be thanked for their time. A contact address and number will be included in the email in the case of any unresolved question, and a link will be provided to reinstate participant video access.
- Conditions
- Psychoeducation
- Being tested
- ADHD Psycheducation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADHD PsycheducationOther
The videos will disseminate evidence-based strategies for the management of Attention Deficit Hyperactivity Disorder (ADHD). Each video, roughly two minutes, will both introduce the viewer to a single ADHD management strategy and explain how said strategy can effectively be integrated into their life.
| Study group | Role | What they receive |
|---|---|---|
| Video 1 | Other | Ten-day exposure to one of two randomly assigned psychoeducational videos. Administration of outcome measures pre and post. Receives: Other: ADHD Psycheducation |
| Video 1 Washout | No intervention | Ten-day washout period between access to the first and second videos. |
| Video 2 | Other | Ten-day exposure to the second of the two randomly assigned psychoeducational videos. Administration of outcome measures pre and post. Receives: Other: ADHD Psycheducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tuckman Condensed Procrastination Scale (TCPS) Change (Video One)
The TCPS is a 16-question condensed version of the original Tuckman Procrastination Scale and has been validated as the gold standard for the evaluation of procrastination proclivity. The TCPS assesses respondent behaviour by posing self-statements that can either be agreed or disagreed with on a four-point Likert-type scale. Out of the sixteen questions, five are reversed coded to promote accurate responding.
Measured: Measured at days 0 and 10. Day 0 serves as a baseline for changes at Day 10 following exposure to video one.
Tuckman Condensed Procrastination Scale (TCPS) Change (Video Two)
The TCPS is a 16-question condensed version of the original Tuckman Procrastination Scale and has been validated as the gold standard for the evaluation of procrastination proclivity. The TCPS assesses respondent behaviour by posing self-statements that can either be agreed or disagreed with on a four-point Likert-type scale. Out of the sixteen questions, five are reversed coded to promote accurate responding.
Measured: Measured at days 20 and 30. Day 20 serves as a quasi-baseline--following washout--for changes at Day 30 following exposure to video two.
Secondary outcomes (2)
Adult ADHD Self-Report Scale (ASRS) Change (Video One)
The ASRS is an 18-item self-report screening scale used to assess adult ADHD. Each ASRS item contains a five-point scale where participants indicate how frequently they conduct themselves in the described manner; item responses can range from 'Never' to 'Very Often', where responses of 'Often' or 'Very Often' are consistent with ADHD typical dysfunction. When participant responses meet the criterion for ADHD typical dysfunction on at least 4 out of 6 screener items (denoted as 'Part A'), said participant will meet inclusion for the study. The remaining 12 ASRS items ('Part B') will be administered for use in the event that the screener criteria are met, and thus a need for further psychometric gradation arises.
Measured: Measured at days 0 and 10. Day 0 serves as a baseline for changes at Day 10 following exposure to video one.
Adult ADHD Self-Report Scale (ASRS) Change (Video Two)
The ASRS is an 18-item self-report screening scale used to assess adult ADHD. Each ASRS item contains a five-point scale where participants indicate how frequently they conduct themselves in the described manner; item responses can range from 'Never' to 'Very Often', where responses of 'Often' or 'Very Often' are consistent with ADHD typical dysfunction. When participant responses meet the criterion for ADHD typical dysfunction on at least 4 out of 6 screener items (denoted as 'Part A'), said participant will meet inclusion for the study. The remaining 12 ASRS items ('Part B') will be administered for use in the event that the screener criteria are met, and thus a need for further psychometric gradation arises.
Measured: Measured at days 20 and 30. Day 20 serves as a quasi-baseline--following washout--for changes at Day 30 following exposure to video two.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start22 Nov 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychoeducationStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The videos will be evaluated in a split-exposure clinical trial, whereby outpatients will be randomly assigned access to one of the two proof-of-concept videos for unlimited viewing. After ten days of access, the patients will spend an additional ten days without video access. The first ten-day procedure will then be repeated once over, with each participant now gaining access to the opposing proof-of-concept video. Clinical impairment data along with patient perspectives will be gathered at each transition junction for use in pre- and post-exposure analyses. The investigators hope to find meaningful improvements in patient functioning-along with a positive reception to the video format-such as to warrant further clinical investigation.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170868
- Sponsor's protocol ID
- 7850
- Status last verified
- Aug 2020
- First submitted
- 12 Nov 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A as the data are a simple proof-of-concept.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducational Video Series - Proof of Concept
- ClinicalTrials.gov ID
- NCT04170868
- Acronym / sponsor ID
- 7850
- Conditions
- Psychoeducation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 20 Nov 2019 (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.
The purpose of this study is to produce and then assess a psychoeducational video series intended for use amongst an adult attention deficit/hyperactive clinical population. The videos will disseminate evidence-based strategies for the management of Attention Deficit Hyperactivity Disorder (ADHD). Each video, roughly two minutes, will both introduce the viewer to a single ADHD management strategy and explain how said strategy can effectively be applied. The collective of the finished video series will aim to cover the breadth of common ADHD-related issues. An example of the animated video styling can be found at the following link: bit.ly/ADHD_Ethics. The investigators will evaluate these videos in a proof of concept program, looking at outcomes in both functional skill development and patient perspective. The results will be presented in an undergraduate thesis presentation.
Detailed description
The study will consist of four phases, each involving the completion of several self-report metrics following video exposure or the lack thereof. The investigators expect 30-40 patients to progress through a quadriphasic design.
Phase 1:
Upon understanding and signing an informed consent form, participants will complete a short demographics questionnaire that will enquire into their age, education level, and gender, but will not include specific identifying information such as name, initials, email, or home address.
Next, participants will be asked to complete a survey containing both the Tuckman Condensed Procrastination Scale (TCPS) and the Adult ADHD Self-Report Scale (ASRS). The data that are gathered from the ASRS will be used as a core inclusion-exclusion metric.
Finally, participants will be briefed on the video access system and then given their unique login credentials, which allow the investigators to track individual usage metrics. The investigators will then explain that for the next ten days the participant will have unlimited access to a single, randomly assigned experimental video (with participants split between one of two videos) adding that at the third and seventh days the participant will receive-pending consent-a friendly email reminder of their ability to access the video. Any questions will be addressed at this point.
All in, the time required to complete Phase 1 for a single participant will be 30-45 minutes.
Phase 2:
After ten days have elapsed, the participant will be sent an online survey link containing the TCPS, ASRS, and a Video Review Survey. The email will also explain how video access over the upcoming ten days will be restricted-as Phase 3 of the study commences-but that they need not worry as full-access will be reinstated following completion of the study. With that, participants will be reminded of the investigator's contact information and left to continue using the learned strategies for the upcoming ten days.
Phase 3:
Following the ten day washout period, participants will be sent another online survey link containing the TCPS and ASRS. The email will also contain access to the second of the two videos, along with a re-explanation of how the investigators hope they use it. From here, another ten-day exposure period will begin.
Phase 4:
After completing the second ten-day exposure period (totalling one month's time), the participant will be asked to answer a final Future Video Survey. Once the survey has been answered, the participant will have finished the study and will be thanked for their time. A contact address and number will be included in the email in the case of any unresolved question, and a link will be provided to reinstate participant video access.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The videos will be evaluated in a split-exposure clinical trial, whereby outpatients will be randomly assigned access to one of the two proof-of-concept videos for unlimited viewing. After ten days of access, the patients will spend an additional ten days without video access. The first ten-day procedure will then be repeated once over, with each participant now gaining access to the opposing proof-of-concept video. Clinical impairment data along with patient perspectives will be gathered at each transition junction for use in pre- and post-exposure analyses. The investigators hope to find meaningful improvements in patient functioning-along with a positive reception to the video format-such as to warrant further clinical investigation.
| Arm | Type | Receives |
|---|---|---|
| Video 1 | Other | Other: ADHD PsycheducationTen-day exposure to one of two randomly assigned psychoeducational videos. Administration of outcome measures pre and post. |
| Video 1 Washout | No intervention | –Ten-day washout period between access to the first and second videos. |
| Video 2 | Other | Other: ADHD PsycheducationTen-day exposure to the second of the two randomly assigned psychoeducational videos. Administration of outcome measures pre and post. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 and up
- Ability to fill out a computerized form
- Ability to access the Internet
- Ability/Willingness to watch several psychoeducational videos
- Ability/Willingness to understand and abide by the procedures and the acknowledge disclosure statement
Key exclusion criteria (6 listed)
- Under 18 years of age
- Inability to fill out a computerized form
- Does not currently have Internet access
- Inability/Unwillingness to watch several psychoeducational videos
- Inability/Unwillingness to understand and abide by the procedures and acknowledge disclosure statement
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 |
|---|---|---|
| ADHD PsycheducationThe videos will disseminate evidence-based strategies for the management of Attention Deficit Hyperactivity Disorder (ADHD). Each video, roughly two minutes, will both introduce the viewer to a single ADHD management strategy and explain how said strategy can effectively be integrated into their life. | Other | Video 1, Video 2 |
Primary outcome
Tuckman Condensed Procrastination Scale (TCPS) Change (Video One)
Time frame: Measured at days 0 and 10. Day 0 serves as a baseline for changes at Day 10 following exposure to video one.
The TCPS is a 16-question condensed version of the original Tuckman Procrastination Scale and has been validated as the gold standard for the evaluation of procrastination proclivity. The TCPS assesses respondent behaviour by posing self-statements that can either be agreed or disagreed with on a four-point Likert-type scale. Out of the sixteen questions, five are reversed coded to promote accurate responding.
Tuckman Condensed Procrastination Scale (TCPS) Change (Video Two)
Time frame: Measured at days 20 and 30. Day 20 serves as a quasi-baseline--following washout--for changes at Day 30 following exposure to video two.
The TCPS is a 16-question condensed version of the original Tuckman Procrastination Scale and has been validated as the gold standard for the evaluation of procrastination proclivity. The TCPS assesses respondent behaviour by posing self-statements that can either be agreed or disagreed with on a four-point Likert-type scale. Out of the sixteen questions, five are reversed coded to promote accurate responding.
2 secondary outcomes
Adult ADHD Self-Report Scale (ASRS) Change (Video One)
Time frame: Measured at days 0 and 10. Day 0 serves as a baseline for changes at Day 10 following exposure to video one.
Adult ADHD Self-Report Scale (ASRS) Change (Video Two)
Time frame: Measured at days 20 and 30. Day 20 serves as a quasi-baseline--following washout--for changes at Day 30 following exposure to video two.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No. N/A as the data are a simple proof-of-concept.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ADHD Psycheducation in people with Psychoeducation, run by McMaster University.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Tuckman Condensed Procrastination Scale (TCPS) Change (Video One) (time frame: Measured at days 0 and 10. Day 0 serves as a baseline for changes at Day 10 following exposure to video one.). The study lists 2 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 2 Sep 2020.