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

NCT ID: NCT05386251

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-18

Study Completion Date

2022-09-30

Brief Summary

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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

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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

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

BPT/OST

Intervention Type BEHAVIORAL

See Arm description.

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.

Group Type SHAM_COMPARATOR

Peer Support

Intervention Type BEHAVIORAL

See Arm description

Interventions

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BPT/OST

See Arm description.

Intervention Type BEHAVIORAL

Peer Support

See Arm description

Intervention Type BEHAVIORAL

Other Intervention Names

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STAND-Group

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Margaret Sibley

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Margaret Sibley, Ph.D.

Role: CONTACT

206) 884-1424

Other Identifiers

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00003308

Identifier Type: -

Identifier Source: org_study_id

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