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

NCT05386251 | Withdrawn Phase 2

• 1 other identifier: 00003308
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ADHD

Keywords

ADHD; Behavioral Intervention; Telehealth

Outcome Measures

Primary Outcomes (3)

• ADHD Symptoms

  Parent and Self Ratings on the SNAP Rating Scale, SNAP (0-3)

  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 Outcomes (9)

• Academic Motivation

  Change from Baseline through 3 months after Post-Treatment, an average of 6 months

• Academic Motivation

  Change from Baseline through 3 months after Post-Treatment, an average of 6 months

• Executive Functions

  Change from Baseline through 3 months after Post-Treatment, an average of 6 months

• Organization, Time Management, and Planning

  Change from Baseline through 3 months after Post-Treatment, an average of 6 months

• Parent Academic Involvement

  Change from Baseline through 3 months after Post-Treatment, an average of 6 months

Other Outcomes (7)

• Treatment Satisfaction

  At Post-treatment, approximately 8 weeks after initial group session

• Treatment Fidelity

  Through Treatment Completion, an average of 8 weeks

• Treatment Barriers

  At Post-treatment, approximately 8 weeks after initial group session

Study Arms (2)

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.

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.

Behavioral: Peer Support

Interventions

BPT/OST BEHAVIORAL

See Arm description.

Also known as: STAND-Group

Behavioral Parent Training/Organization Skills Training

Peer Support BEHAVIORAL

See Arm description

Peer support

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The same providers will deliver both treatment arms and so it will be difficult to fully mask the providers to which group is active (based on their natures). However, participants will be told that both groups are active and outcomes assessors will not be informed about group membership.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: May 23, 2022
• Study Start: May 18, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within six months of the completion of the trial