Executive Function Play Opportunities for Children With Down Syndrome (EXPO)
Executive Function Intervention for Young Children With Down Syndrome
調査の概要
詳細な説明
The Executive Function Play Opportunities (EXPO) study is a sequential, multiple assignment, randomized trial (SMART) evaluating adaptive caregiver-mediated intervention pathways for improving executive function (EF) in children with Down syndrome (DS). At baseline, all participants will complete an assessment including laboratory-based measures of EF, parent-report measures of EF, and intensive ecological measurement of EF using the iBehavior app. Participants will then be randomized in a 1:4 ratio to receive either a delayed-treatment control condition or the EXPO intervention, with a target total sample size of 150.
During stage 1, participants in the EXPO condition will complete 4 weeks of standard EXPO intervention. The initial weeks of EXPO consist of 2 weeks of EXPO Ready activities followed by 2 weeks of Working Memory activities, and all participants in the EXPO intervention receive ongoing support from an EXPO coach.
At the stage 1 evaluation, conducted 4 weeks after starting EXPO, all participants will complete the laboratory-based EF assessment battery. EXPO participants will be assessed for response to the intervention and classified as early or slower responders based on prespecified criteria for improvement in laboratory-based EF performance.
Early responders will be assigned to the standard EXPO intervention in stage 2 and continue with activities targeting inhibition, cognitive flexibility, planning, and consolidation of skills for a total of 12 weeks. Slower responders will be randomly assigned in a 1:1 ratio to either the EXPO Extended or EXPO Foundations pathway. The EXPO Extended pathway will include the same core activities as the EXPO standard pathway but will provide additional intervention time, for a total of 18 weeks. The EXPO Foundations pathway will begin with a block of activities targeting early social communication and regulation to provide a foundation for activity engagement, followed by more foundational versions of activities targeting inhibition and cognitive flexibility. The EXPO Foundations pathway will continue for a total of 12 weeks.
All participants will complete laboratory and parent-report measures of EF immediately post-intervention and 3 months later. Participants in the delayed-treatment control condition will not receive EXPO during the initial study period but will complete the same assessments as participants in the EXPO intervention. Following completion of the 3-month follow-up, participants in the delayed-treatment control condition will be offered the EXPO intervention.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kaylyn Van Deusen, MS
- 電話番号：9704911969
- メール：kaylyn.van_deusen@colostate.edu
研究連絡先のバックアップ
- 名前：Miranda Pinks, MS
- 電話番号：970-4911969
- メール：miranda.pinks@colostate.edu
研究場所
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Colorado
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Fort Collins、Colorado、アメリカ、80523
- Colorado State University
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主任研究者：
- Deborah Fidler, PhD
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コンタクト：
- Deborah Fidler, PhD
- 電話番号：9702194288
- メール：Deborah.fidler@colostate.edu
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コンタクト：
- Kaylyn Van Deusen, MS
- 電話番号：970-4911969
- メール：kaylyn.Van_Deusen@colostate.edu
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副調査官：
- Nathaniel Riggs, Phd
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副調査官：
- Susan Hepburn, PhD
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副調査官：
- Lisa Daunhauer, ScD
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CO
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Padova、CO、イタリア、80526
- University of Padova
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コンタクト：
- Silvia Lanfranchi, PhD
- 電話番号：9702194288
- メール：silvia.lanfranchi@unipd.it
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- confirmed medical diagnosis of Down syndrome
Exclusion Criteria:
- no complete hearing or vision loss
- primary exposure to English or Italian
研究計画
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：順次割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし：Delayed-Treatment Control
Participants do not receive EXPO during the initial study period and complete the same EF assessments as participants in the EXPO intervention pathways.
Participants are offered the EXPO intervention following completion of the 3-month follow-up.
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実験的：EXPO Standard Pathway
Early responders to EXPO at the stage 1 evaluation are assigned to the standard, 12 -week intervention with activities refined from EXPO 2.0.
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EXPO is a novel intervention that targets the development of EF through play-based opportunities for children with DS and their primary caregivers.
EXPO is a 'syndrome-informed' intervention in that all activities are tailored to phenotypic strengths and challenges associated with DS, accounting for cognitive, language, and motor presentations frequently observed in this population.
EXPO is also designed to elicit maximal engagement and enjoyment for children and their caregivers by embedding opportunities to strengthen EF component processes in the context of play and games.
他の名前：
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アクティブコンパレータ：Adaptive Pathway 1/EXPO Extended
Half of participants classified as slower responders to EXPO at the stage 1 evaluation are randomly assigned to EXPO Extended.
EXPO Extended provides the standard pathway activities with an extended 18-week schedule.
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Alternative EXPO pathway that extends the length of the EXPO intervention from 12 to 18 weeks to provide more time and opportunity for skill acquisition.
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アクティブコンパレータ：Adaptive Pathway 2/EXPO Foundations
Half of participants classified as slower responders to EXPO at the stage 1 evaluation are randomly assigned to EXPO Foundations.
EXPO Foundations provides a more foundational pathway with simplified activities, and additional activities that emphasize early communication and regulatory processes.
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An augmented version of EXPO that places a greater emphasis on precursors to EXPO activity engagement, including an increased number of social routine activities, enhanced presses for social communication behaviors like joint attention, enhanced focus on early self-regulation skills, and adaptations of all EXPO activities in each block that emphasize more foundational aspects of play.
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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 |
|---|---|---|
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Adapted Reverse Categorization
時間枠：From enrollment to the end of treatment, with a 3-month follow-up
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Rule switch task that involves sorting by color, and then reversing the sort rule
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From enrollment to the end of treatment, with a 3-month follow-up
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Zoo Animal Switch
時間枠：From enrollment to the end of treatment, with a 3-month follow-up
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Rule switch task that involves sorting large and small animal pairs by size into large and small buckets, then reversing the rule to put large animals into the small bucket, and small animals into the large bucket
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From enrollment to the end of treatment, with a 3-month follow-up
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Developmental Profiles-4 Cognitive domain
時間枠：From enrollment to the end of treatment, with a 3-month follow-up
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Growth Scale Values in the Developmental Profiles-4 Cognitive domain
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From enrollment to the end of treatment, with a 3-month follow-up
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Developmental Profiles-4 Social-emotional domain
時間枠：From enrollment to the end of treatment, with a 3-month follow-up
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Growth Scale Values in the Developemental Profiles-4 Social-Emotional domain
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From enrollment to the end of treatment, with a 3-month follow-up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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iBehavior Ecological Momentary Assessment
時間枠：From enrollment to the end of treatment, with a 3-month follow-up
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From enrollment to the end of treatment, with a 3-month follow-up
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Self ordered pointing: Garage Game
時間枠：From enrollment to the end of treatment, with a 3-month follow-up
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Self-ordered pointing task that requires working memory/updating
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From enrollment to the end of treatment, with a 3-month follow-up
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BRIEF-Preschool Inhibition Domain
時間枠：From enrollment to the end of treatment, with a 3-month follow-up
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Standardized Caregiver Report of Executive Functioning for Preschool aged children
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From enrollment to the end of treatment, with a 3-month follow-up
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Hearts and Flowers
時間枠：From enrollment to the end of treatment, with a 3-month follow-up
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Opposites task that involves matching cards to the opposite type of card
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From enrollment to the end of treatment, with a 3-month follow-up
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Developmental Profiles-4 Adaptive Behavior domain
時間枠：From enrollment to the end of treatment, with a 3-month follow-up
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Growth Scale Values in the Developmental Profiles-4 Adaptive Behavior domain
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From enrollment to the end of treatment, with a 3-month follow-up
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Building Task
時間枠：From enrollment to the end of treatment, with a 3-month follow-up
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Shape design task that involves reproducing a pattern of blocks according to a design produced by the examiner
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From enrollment to the end of treatment, with a 3-month follow-up
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協力者と研究者
協力者
捜査官
- 主任研究者：Deborah Fidler、Colorado State University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 7190 (CTEP)
- R61HD115161 (米国 NIH グラント/契約)
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?
IPD プランの説明
Upon completion of this study, and annually throughout the thre-year project period, our team will share all developmental and behavioral with the NIH INCLUDE Data Coordinating Center.
Data will also be collected from a parent or guardian via questionnaire and the iBehavior smartphone application. Data that will be preserved and shared include demographic information, developmental assessments composite scores, caregiver rating composite scores for behavioral dimensions, and caregiver-reported iBehavior composite data. The data transformation approach for all aggregate-level data will be specified in detail in a protocol manual for reproducibility. Information regarding data content, format, and organization will be available to any research colleagues accessing the DCC database. All shared data will be formatted in accordance with current standards and norms in the field of
IPD 共有時間枠
IPD 共有アクセス基準
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
米国FDA規制機器製品の研究
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