Clinical trial NCT05386251: Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges
Official title: Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: ADHD
Keywords: ADHD
Behavioral Intervention
Telehealth
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 120
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Students are randomized in a 1:1 allocation ratio to the active treatment of the control group. Participants will be randomized to the strategies or peer support groups using a stratified randomization procedure that randomizes within grade level (i.e., middle school or high school). After 20 students are randomized to a group, the group will be scheduled to begin.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Students will be required to,

* be in the sixth through twelfth grade,
* have elevated ADHD symptoms
* documented impairment according to the SNAP
* documented impairment according to Impairment Rating Scale.
* Students must be 17.5 or younger at the time of enrollment to ensure that they are still under 18 at the expected completion of the study.

Parents of eligible students will also participate.

Exclusion Criteria:

Students may not be,

* in a self-contained special education classroom,
* possess intellectual disability
* be non-English speaking
* be older than 18 years old at time of enrollment

Primary outcomes:
measure: ADHD Symptoms
timeFrame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
measure: Academic Impairment: Grade Point Average
timeFrame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
measure: Academic Impairment: School Attendance
timeFrame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Secondary outcomes:
measure: Academic Motivation
timeFrame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
measure: Academic Motivation
timeFrame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
measure: Executive Functions
timeFrame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
measure: Organization, Time Management, and Planning
timeFrame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
measure: Parent Academic Involvement
timeFrame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
measure: Academic Impairment Rating Scale
timeFrame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
measure: Parent-Teen Conflict
timeFrame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
measure: Goal Setting
timeFrame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
measure: Parent Autonomy Support
timeFrame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Other outcomes:
measure: Treatment Satisfaction
timeFrame: At Post-treatment, approximately 8 weeks after initial group session
measure: Treatment Fidelity
timeFrame: Through Treatment Completion, an average of 8 weeks
measure: Treatment Barriers
timeFrame: At Post-treatment, approximately 8 weeks after initial group session
measure: Treatment Credibility
timeFrame: At Post-treatment, approximately 8 weeks after initial group session
measure: Video Conferencing Feasibility
timeFrame: At Post-treatment, approximately 8 weeks after initial group session
measure: Treatment Attendance
timeFrame: Through study completion, an average of 8 weeks, at each Session of Treatment
measure: Treatment Homework Completion
timeFrame: Through study completion, an average of 8 weeks, at each Session of Treatment
Locations:
Study officials:
References: