ADHDPhase 2/3STAND-GNCT05386251
Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges
A Phase 2/3 study testing BPT/OST and Peer Support in people with ADHD, run by Seattle Children's Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- BPT/OST and Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2022to 30 Sep 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- ADHD
- Being tested
- BPT/OST, Peer Support
- Keywords
- ADHD, Behavioral Intervention, Telehealth
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPT/OSTBehavioural
Also called STAND-Group
See Arm description.
Peer SupportBehavioural
See Arm description
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Parent Training/Organization Skills Training | Experimental | 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. Receives: Behavioral: BPT/OST |
| Peer support | Sham comparator | 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. Receives: Behavioral: Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Symptoms
Parent and Self Ratings on the SNAP Rating Scale, SNAP (0-3)
Measured: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Impairment: Grade Point Average
Official School Records
Measured: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Impairment: School Attendance
Official School Records
Measured: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Secondary outcomes (9)
Academic Motivation
Expectancy-Value Questionnaire -Self Version, (1-5) Higher scores can mean better outcome
Measured: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Motivation
Change Ruler -Self Version
Measured: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Executive Functions
BRIEF Rating Scale -Parent Version, BRIEF
Measured: 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, AAPC
Measured: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent Academic Involvement
Parent Academic Management Scale - Parent Version, PAMS (0-5) Higher scores can mean better outcome
Measured: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Impairment Rating Scale
Impairment Rating Scale - Parent Version
Measured: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent-Teen Conflict
Conflict Behavior Questionnaire-20 - Parent, Self Version, CBQ
Measured: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Goal Setting
Goal Setting Questionnaire- Parent and Self
Measured: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent Autonomy Support
Parent Promotion of Volitional Functioning- Self Report
Measured: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start18 May 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Why it stopped: Lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Sibley, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386251
- Sponsor's protocol ID
- 00003308
- Acronym
- STAND-G
- Status last verified
- Apr 2026
- First submitted
- 24 Sep 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will submit data from this trial to the OSF data repository upon completion of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges
- ClinicalTrials.gov ID
- NCT05386251
- Acronym / sponsor ID
- STAND-G / 00003308
- Conditions
- ADHD
- Keywords
- ADHD, Behavioral Intervention, Telehealth
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Behavioral Parent Training/Organization Skills Training | Experimental | Behavioral: BPT/OSTParents 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. |
| Peer support | Sham comparator | Behavioral: Peer SupportParents 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. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPT/OSTAlso: STAND-GroupSee Arm description. | Behavioural | Behavioral Parent Training/Organization Skills Training |
| Peer SupportSee Arm description | Behavioural | Peer support |
Primary outcome
ADHD Symptoms
Time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent and Self Ratings on the SNAP Rating Scale, SNAP (0-3)
Academic Impairment: Grade Point Average
Time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Official School Records
Academic Impairment: School Attendance
Time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Official School Records
9 secondary outcomes
Academic Motivation
Time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Motivation
Time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Executive Functions
Time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Organization, Time Management, and Planning
Time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent Academic Involvement
Time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Impairment Rating Scale
Time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent-Teen Conflict
Time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Goal Setting
Time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent Autonomy Support
Time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. We will submit data from this trial to the OSF data repository upon completion of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BPT/OST and Peer Support in people with ADHD, run by Seattle Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Symptoms (time frame: Change from Baseline through 3 months after Post-Treatment, an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.