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Exploring the Group Visit Model for Pediatric ADHD Management in the Medical Home

2014年5月22日 更新者：Nerissa Bauer、Indiana University
Attention deficit hyperactivity disorder (ADHD) affects 8% of US youth. Even though evidence shows medications are effective in reducing ADHD symptoms, many families experience ongoing parenting stress around parent-child interactions. Children often have ongoing impairments in functioning. ADHD is a common condition identified and managed by primary care pediatricians. However current care in the clinic is not optimal to address parents' and children's needs around ADHD chronic care. Time is the biggest barrier. Group visits are a viable option to improve pediatric ADHD care, but requires extensive study. The goal of this proposed study is to test the feasibility and effectiveness of the group visit model for ADHD management within pediatric primary care. This study will be a randomized feasibility study that will generate important pilot data, as well as result in an innovative, exportable pediatric ADHD group curriculum for primary care practice.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

The specific research aims of this proposal are:

Aim 1: Develop and test a group curriculum for parents of children (age 6 to 18 years) with ADHD to increase parental knowledge about ADHD and self-confidence in managing issues related to their child's functioning in school and home.

Aim 2: Develop and test a group curriculum for children (age 6 to 18 years) with ADHD to teach social and educational skills to improve adaptive functioning at home and school.

Aim 3: To assess any added benefits to the parents, children and providers (related to group visit logistics and satisfaction) the group visit model has over usual care.

Aim 4: To assess whether the group visit model can be done efficiently and effectively in the setting of an actual general pediatric practice.

研究の種類

介入

入学 (実際)

56

段階

  • 適用できない

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。

研究場所

  • アメリカ
    • Indiana
      • Indianapolis、Indiana、アメリカ、46202
        • General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health

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

6年～18年 (子、大人)

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:

  • children with ADHD and their parents
  • children receiving routine ADHD follow-up care at the study clinic
  • if on medication, must be "stable" for 3 months and therefore not needing monthly clinic appointments to titrate medication

Exclusion Criteria:

  • conduct disorder
  • autism
  • moderate to severe intellectual disability

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：ヘルスサービス研究
  • 割り当て：ランダム化
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：ADHD Group Curriculum
Participants assigned to the group visit intervention agree to participate in 5 group visits every 3 months rather than individual ADHD follow-up visits to the clinic. Parents and children participate in separate but simultaneously run groups. Group portion is 60 minutes and then parent-child dyads complete individual visits for medication titration and physical exam.
行動：ADHD Group Curriculum
Study specific ADHD Group curriculum was designed and implemented for the study. Parent curriculum included the following topics: What is ADHD, medications, educational advocacy, how to prevent behavioral issues and how to defuse common behavioral challenges and manage stress. Child curriculum included the following topics: what is ADHD, social skills and friendships, handling school and organization skills, understanding feelings and managing negative emotions
介入なし：Control
Participants continue to go to the clinic for 5 routine ADHD follow-up visits to the clinic every 3 months as usual clinical protocol.

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
Number of clinic visits during study period
時間枠：12 months
Feasibility of group visit model was measured as number of visits to the clinic by chart review. We also looked at the number of group visits a family attended based on the sign in sheet provided at the beginning of each session.
12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Parent-rated ADHD symptoms
時間枠：Baseline
Parents completed validated Vanderbilt Rating Scale regarding child's ADHD symptoms. Measures response to ADHD treatment, primarily medication.
Baseline
Parent-rated ADHD symptoms
時間枠：12 months
Parents complete validated Vanderbilt Rating Scale to report child symptoms of ADHD. Used to assess response to treatment, usually medication.
12 months
Child functioning at home
時間枠：Baseline
Parent report of adaptive functioning of child in the home setting using the Home Situations Questionnaire
Baseline
Child functioning at home
時間枠：12 months
Parents report of child's adaptive functioning in the home setting using the Home Situations Questionnaire.
12 months
Teacher report of child's ADHD symptoms
時間枠：baseline
teachers received the validated Vanderbilt rating scale to rate student's ADHD symptoms in the classroom. Parents were given the tool at time of enrollment and asked to give to teacher as per clinical care guidelines. Monitors impact of ADHD treatment, usually medication.
baseline
teacher report of child's ADHD symptoms in school
時間枠：12 months
teachers received the validated Vanderbilt rating scale to rate student's ADHD symptoms in the classroom. Parents were given the tool at time of enrollment and asked to give to teacher as per clinical care guidelines. Monitors impact of ADHD treatment, usually medication.
12 months
Child functioning at school
時間枠：baseline
teachers were invited to provide rating of child's adaptive functioning at school. Parent given the tool at time of enrollment and instructed to give to teacher as per clinical care guidelines.
baseline
teacher rating of child's functioning in school
時間枠：12 months
teachers were invited to provide rating of child's adaptive functioning at school. Parent given the tool at time of enrollment and instructed to give to teacher as per clinical care guidelines.
12 months
Quality of Life
時間枠：baseline
Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.
baseline
Quality of Life
時間枠：12 months
Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.
12 months
Parenting self-efficacy
時間枠：Baseline
Parent reported sense of confidence using the Parenting Sense of Confidence Scale
Baseline
Parenting Self-efficacy
時間枠：12 months
Parent-reported sense of confidence using Parenting Sense of Confidence scale
12 months
Parental knowledge, satisfaction towards medication treatment
時間枠：baseline
Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment
baseline
Parent knowledge and satisfaction towards medication treatment
時間枠：12 months
Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment
12 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Participant feedback about the curriculum
時間枠：after each group visit over 365 days
parents and children separately complete a short 4 question survey about what they liked, what they did not like, what they are excited about doing after the group visit and suggestions for improvement. Data used to continually refine the curriculum. At the 5th group visit, participants participated in informal discussion about the group visit model and overall satisfaction with the intervention
after each group visit over 365 days
Pediatric facilitator and staff feedback
時間枠：at the end of each group visit over 365 days
collected informal feedback and reflection about the process, barriers and positive experiences overall about the group visit model and impact on the clinical workflow, suggestions for improvement that was used to continually refine the model for quality improvement
at the end of each group visit over 365 days

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

Indiana University

捜査官

  • 主任研究者：Nerissa S Bauer, MD, MPH、Indiana University School of Medicine

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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

2012年6月1日

一次修了 (実際)

2013年10月1日

研究の完了 (実際)

2013年11月1日

試験登録日

最初に提出

2014年5月18日

QC基準を満たした最初の提出物

2014年5月20日

最初の投稿 (見積もり)

2014年5月23日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年5月26日

QC基準を満たした最後の更新が送信されました

2014年5月22日

最終確認日

2014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

  • 1204008526

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

ADHD Group Curriculumの臨床試験

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