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

ADHD Clinical Trial

— STAND-G  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05386251
• Other study ID #: 00003308
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: May 18, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2022
• Source: Seattle Children's Hospital
• Contact: Margaret Sibley, Ph.D.
• Phone: 206) 884-1424
• Email: margaret.sibley[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• BPT/OST
See Arm description.
• Peer Support
See Arm description

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Satisfaction	Parent and Self Report Satisfaction Survey	At Post-treatment, approximately 8 weeks after initial group session
Other	Treatment Fidelity	Blinded Observers will observe to code for fidelity	Through Treatment Completion, an average of 8 weeks
Other	Treatment Barriers	Parent an Self Reported Barriers Survey	At Post-treatment, approximately 8 weeks after initial group session
Other	Treatment Credibility	Client Credibility Questionnaire-Parent and Self	At Post-treatment, approximately 8 weeks after initial group session
Other	Video Conferencing Feasibility	Video-Conferencing Questionnaire-Parent and Self	At Post-treatment, approximately 8 weeks after initial group session
Other	Treatment Attendance	Group records	Through study completion, an average of 8 weeks, at each Session of Treatment
Other	Treatment Homework Completion	Group records	Through study completion, an average of 8 weeks, at each Session of Treatment
Primary	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
Primary	Academic Impairment: Grade Point Average	Official School Records	Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Primary	Academic Impairment: School Attendance	Official School Records	Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Secondary	Academic Motivation	Expectancy-Value Questionnaire -Self Version	Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Secondary	Academic Motivation	Change Ruler -Self Version	Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Secondary	Executive Functions	BRIEF Rating Scale -Parent Version	Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Secondary	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
Secondary	Parent Academic Involvement	Parent Academic Management Scale - Parent Version	Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Secondary	Academic Impairment Rating Scale	Impairment Rating Scale - Parent Version	Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Secondary	Parent-Teen Conflict	Conflict Behavior Questionnaire-20 - Parent, Self Version	Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Secondary	Goal Setting	Goal Setting Questionnaire- Parent and Self	Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Secondary	Parent Autonomy Support	Parent Promotion of Volitional Functioning- Self Report	Change from Baseline through 3 months after Post-Treatment, an average of 6 months