Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Behavioral: BPT/OST
* Behavioral: Peer Support


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Parent Training/Organization Skills Training<br>Parents will receive 8 weeks of a 90 minute behavioral parent training protocol that focuses on supporting academic and behavioral success in adolescents with ADHD. Teens will receive a simultaneous 8 weeks of a 90 minute organization skills training group. Both groups will be delivered via telehealth. | Behavioral: BPT/OST<br>* See Arm description.<br>* Other names: STAND-Group;|
| Sham Comparator: Peer support<br>Parents and teens will each participate in 8 weeks of a 90 minute peer support group focused on exchange of shared experience and group problem-solving difficulties. Both groups will be delivered via telehealth. | Behavioral: Peer Support<br>* See Arm description<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD Symptoms | Parent and Self Ratings on the SNAP Rating Scale | Change from Baseline through 3 months after Post-Treatment, an average of 6 months | 
| Academic Impairment: Grade Point Average | Official School Records | Change from Baseline through 3 months after Post-Treatment, an average of 6 months | 
| Academic Impairment: School Attendance | Official School Records | Change from Baseline through 3 months after Post-Treatment, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Academic Motivation | Expectancy-Value Questionnaire -Self Version | Change from Baseline through 3 months after Post-Treatment, an average of 6 months | 
| Academic Motivation | Change Ruler -Self Version | Change from Baseline through 3 months after Post-Treatment, an average of 6 months | 
| Executive Functions | BRIEF Rating Scale -Parent Version | Change from Baseline through 3 months after Post-Treatment, an average of 6 months | 
| Organization, Time Management, and Planning | Adolescent Academic Problems Checklist-Parent and Self Version will be used to measure organization, time management and planning | Change from Baseline through 3 months after Post-Treatment, an average of 6 months | 
| Parent Academic Involvement | Parent Academic Management Scale - Parent Version | Change from Baseline through 3 months after Post-Treatment, an average of 6 months | 
| Academic Impairment Rating Scale | Impairment Rating Scale - Parent Version | Change from Baseline through 3 months after Post-Treatment, an average of 6 months | 
| Parent-Teen Conflict | Conflict Behavior Questionnaire-20 - Parent, Self Version | Change from Baseline through 3 months after Post-Treatment, an average of 6 months | 
| Goal Setting | Goal Setting Questionnaire- Parent and Self | Change from Baseline through 3 months after Post-Treatment, an average of 6 months | 
| Parent Autonomy Support | Parent Promotion of Volitional Functioning- Self Report | Change from Baseline through 3 months after Post-Treatment, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, Behavioral Intervention, Telehealth