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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ADHD
• Intervention / Treatment: Behavioral: BPT/OST; Behavioral: Peer Support

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Margaret Sibley, Ph.D.; Phone Number: 206) 884-1424; Email: margaret.sibley@seattlechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Parent Training/Organization Skills Training; 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; See Arm description.; Other Names: STAND-Group
Sham Comparator: Peer support; 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; See Arm description

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Satisfaction	Parent and Self Report Satisfaction Survey	At Post-treatment, approximately 8 weeks after initial group session
Treatment Fidelity	Blinded Observers will observe to code for fidelity	Through Treatment Completion, an average of 8 weeks
Treatment Barriers	Parent an Self Reported Barriers Survey	At Post-treatment, approximately 8 weeks after initial group session
Treatment Credibility	Client Credibility Questionnaire-Parent and Self	At Post-treatment, approximately 8 weeks after initial group session
Video Conferencing Feasibility	Video-Conferencing Questionnaire-Parent and Self	At Post-treatment, approximately 8 weeks after initial group session
Treatment Attendance	Group records	Through study completion, an average of 8 weeks, at each Session of Treatment
Treatment Homework Completion	Group records	Through study completion, an average of 8 weeks, at each Session of Treatment

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 18, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: ADHD; Telehealth; Behavioral Intervention
• Other Study ID Numbers: 00003308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will submit data from this trial to the OSF data repository upon completion of the trial.
• IPD Sharing Time Frame: Within six months of the completion of the trial
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No