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

2022年5月17日 更新者：Margaret Sibley、Seattle Children's Hospital

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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (予想される)

120

段階

  • フェーズ2
  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

11年～17年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：BPT/OST
See Arm description.
他の名前：
  • STAND-Group
偽コンパレータ：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.
行動：Peer Support
See Arm description

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
ADHD Symptoms
時間枠：Change from Baseline through 3 months after Post-Treatment, an average of 6 months
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
時間枠：Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Official School Records
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Impairment: School Attendance
時間枠：Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Official School Records
Change from Baseline through 3 months after Post-Treatment, an average of 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Academic Motivation
時間枠：Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Expectancy-Value Questionnaire -Self Version
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Motivation
時間枠：Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Change Ruler -Self Version
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Executive Functions
時間枠：Change from Baseline through 3 months after Post-Treatment, an average of 6 months
BRIEF Rating Scale -Parent Version
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Organization, Time Management, and Planning
時間枠：Change from Baseline through 3 months after Post-Treatment, an average of 6 months
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
時間枠：Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent Academic Management Scale - Parent Version
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Impairment Rating Scale
時間枠：Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Impairment Rating Scale - Parent Version
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent-Teen Conflict
時間枠：Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Conflict Behavior Questionnaire-20 - Parent, Self Version
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Goal Setting
時間枠：Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Goal Setting Questionnaire- Parent and Self
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent Autonomy Support
時間枠：Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent Promotion of Volitional Functioning- Self Report
Change from Baseline through 3 months after Post-Treatment, an average of 6 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Treatment Satisfaction
時間枠：At Post-treatment, approximately 8 weeks after initial group session
Parent and Self Report Satisfaction Survey
At Post-treatment, approximately 8 weeks after initial group session
Treatment Fidelity
時間枠：Through Treatment Completion, an average of 8 weeks
Blinded Observers will observe to code for fidelity
Through Treatment Completion, an average of 8 weeks
Treatment Barriers
時間枠：At Post-treatment, approximately 8 weeks after initial group session
Parent an Self Reported Barriers Survey
At Post-treatment, approximately 8 weeks after initial group session
Treatment Credibility
時間枠：At Post-treatment, approximately 8 weeks after initial group session
Client Credibility Questionnaire-Parent and Self
At Post-treatment, approximately 8 weeks after initial group session
Video Conferencing Feasibility
時間枠：At Post-treatment, approximately 8 weeks after initial group session
Video-Conferencing Questionnaire-Parent and Self
At Post-treatment, approximately 8 weeks after initial group session
Treatment Attendance
時間枠：Through study completion, an average of 8 weeks, at each Session of Treatment
Group records
Through study completion, an average of 8 weeks, at each Session of Treatment
Treatment Homework Completion
時間枠：Through study completion, an average of 8 weeks, at each Session of Treatment
Group records
Through study completion, an average of 8 weeks, at each Session of Treatment

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Seattle Children's Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2022年5月18日

一次修了 (予想される)

2022年9月30日

研究の完了 (予想される)

2022年9月30日

試験登録日

最初に提出

2021年9月24日

QC基準を満たした最初の提出物

2022年5月17日

最初の投稿 (実際)

2022年5月23日

学習記録の更新

投稿された最後の更新 (実際)

2022年5月23日

QC基準を満たした最後の更新が送信されました

2022年5月17日

最終確認日

2022年5月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 00003308

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

We will submit data from this trial to the OSF data repository upon completion of the trial.

IPD 共有時間枠

Within six months of the completion of the trial

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

ADHDの臨床試験

BPT/OSTの臨床試験

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スポンサーと協力者

医学的状態

薬物療法

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条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
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