Viewing Study NCT05386251


Ignite Creation Date: 2025-12-24 @ 11:51 PM
Ignite Modification Date: 2025-12-25 @ 9:46 PM
Study NCT ID: NCT05386251
Status: UNKNOWN
Last Update Posted: 2022-05-23
First Post: 2021-09-24
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges
Sponsor: Seattle Children's Hospital
Organization:

Study Overview

Official Title: Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges
Status: UNKNOWN
Status Verified Date: 2022-05
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: STAND-G
Brief Summary: The purpose of this study is to test the effectiveness of a telehealth-delivered skills training versus active control group for middle and high school students with ADHD symptoms. Both programs will be delivered digitally (via Zoom).

Investigators will measure student functioning at baseline, post-group, and three-month follow-up. The primary outcomes are ADHD symptoms, student grade point average, and attendance as reported in the gradebook. Secondary outcomes include parent academic support, autonomy, academic motivation, and organization skills. Participant satisfaction with the group will be measured post-group. Group attendance and homework completion will also be measured.
Detailed Description: 120 middle and high school students with elevated ADHD symptoms will be recruited for this study, which will take place over the course of the 2021-2022 academic year. The recruitment strategy will be to distribute information about the study opportunity to educator email lists in South Florida (see appended email template). Educators will be instructed to share information about the study to the parents of students who perceive to experience ADHD symptoms in their schools, regardless of special education status or documentation of a disability.

Students who enroll will be randomly assigned to either receive the STAND-G strategy-based group or a peer-support-based, active control group. Investigators will blind participants and their parents to which group is the active treatment by informing parents and students that participant will be randomly assigned to one of two groups to help improve school difficulties in youth. The two groups will be of equal duration, both will be led by the same instructors; and will differ only in content (teaching strategies vs. facilitating peer support and problem-solving conversations).

Students (and their parents) will complete assessments at baseline, post-group, and three months post-group. School records will be obtained for all time points.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: