Psychoeducational Video Series - Proof of Concept

NCT04170868 | Withdrawn

• 1 other identifier: 7850
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Psychoeducation

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Adult ADHD Self-Report Scale (ASRS) Change (Video One)

  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)

  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.

Other Outcomes (1)

• Video Review Survey (VRS)

  Administered on day 10 and day 30. These are the points in which participants will have completed exposure to videos one and two, respectively.

Study Arms (3)

Video 1

OTHER

Ten-day exposure to one of two randomly assigned psychoeducational videos. Administration of outcome measures pre and post.

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.

Other: ADHD Psycheducation

Interventions

ADHD Psycheducation OTHER

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.

Video 1; Video 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• McMaster University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 20, 2019
• Study Start: November 22, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share