Psychoeducational Video Series - Proof of Concept

Psychoeducation Clinical Trial

Official title:

Psychoeducational Video Series - Proof of Concept

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04170868
• Other study ID #: 7850
• Status: Withdrawn
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: August 2020
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Psychoeducation

Intervention

Other:
• ADHD Psycheducation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Video Review Survey (VRS)	The VRS is a short questionnaire that participants will answer twice, each time following completion of a two-week video access block. The VRS requests participants to provide their opinions on the video-and the strategies contained within-that they had access to for the previous month. Through specific opinions, the investigators are better able to adapt future psychoeducational resources to the needs of people with ADHD.	Administered on day 10 and day 30. These are the points in which participants will have completed exposure to videos one and two, respectively.
Primary	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 at days 0 and 10. Day 0 serves as a baseline for changes at Day 10 following exposure to video one.
Primary	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 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	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 at days 0 and 10. Day 0 serves as a baseline for changes at Day 10 following exposure to video one.
Secondary	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 at days 20 and 30. Day 20 serves as a quasi-baseline--following washout--for changes at Day 30 following exposure to video two.