School-Age Children With Autism With Limited Expressive Language Skills
2021年3月9日 更新者：Rebecca Landa、Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
School-Age Children With Autism With Limited Expressive Language Skills: An Intervention Study
This project will address a major challenge to the field of autism research: improving expressive communication in children with autism who have reached school age but have not acquired functional spoken language (non-verbal school aged children with autism; NVSACA).
Fifteen children who completed the RO1 ICAN intervention (NCT01018407) at the Kennedy Krieger site and follow-up testing but continue to have minimal functional spoken language will be participants in this study. After eligibility is established, participants will be randomly assigned to a baseline duration of one week, two weeks or three weeks before the start of active treatment. Once the baseline duration is completed, participants begin active treatment one hour of intervention three days per week in the participants' school setting. In month 2, weekly teacher trainings begin. In month 5, weekly parent trainings begin to improve the child's generalization of skills and teach parents the strategies implemented in their child's treatment. Post-baseline and post-treatment assessments will be completed in the lab at a time that is convenient for the participants' families.
調査の概要
研究の種類
介入
入学 (実際)
13
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
-
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Maryland
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Baltimore、Maryland、アメリカ、21211
- Kennedy Krieger Institute
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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
4年～7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:
- Diagnosis of autism by a licensed psychologist or board certified developmental pediatrician, or child and adolescent psychiatrist, confirmed by the Autism Diagnostic Observation Schedule (ADOS; Lord, Rutter, DiLavore, & Risi, 1999)
- Chronological age between 4.0 years and 7 years, 11 months
- Reynell developmental score ≤ 24 months, ADOS A1 score of 2, 3 or 8
- Nonverbal IQ of ≥ 40 (Leiter International Performance Scale-Revised (Leiter-R), Roid & Miller, 2007)
- Children have participated in and completed follow-up testing for the ICAN study.
Exclusion Criteria:
- Major medical conditions other than autism (e.g., genetic disorders [e.g., Fragile X, Down syndrome, tuberous sclerosis], blindness or deafness, and motor disabilities such as cerebral palsy;
- Uncontrolled seizures;
- Self-injurious behavior or moderate to severe aggression.
- Children in foster care.
- Children who are exposed to < 50% English throughout their typical day.
- Children currently participating in another intervention/treatment study.
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：単一グループの割り当て
- 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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実験的：1 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist.
In this case, the duration is 1 week before your child begins active treatment with their interventionist.
|
The intervention has 3 components:
|
|
実験的：2 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist.
In this case, the duration is 2 weeks before your child begins active treatment with their interventionist.
|
The intervention has 3 components:
|
|
実験的：3 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist.
In this case, the duration is 3 weeks before your child begins active treatment with their interventionist.
|
The intervention has 3 components:
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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 |
|---|---|---|
|
Change in Baseline Spontaneous Language
時間枠：Weekly throughout the 5 month intervention (baseline and 5 months)
|
The number of unprompted spontaneous language during a 15min play sample.
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Weekly throughout the 5 month intervention (baseline and 5 months)
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change in Baseline Autism Diagnostic Observation Schedule
時間枠：5 months into treatment (at completion of intervention)
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5 months into treatment (at completion of intervention)
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Change in Baseline Reynell
時間枠：5 months into treatment (at completion of intervention)
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5 months into treatment (at completion of intervention)
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Changes in Baseline Early Social Communication Scales (ESCS)
時間枠：5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
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5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
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Changes in Baseline Structured Play Assessment
時間枠：5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
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5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
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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。
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1月1日
一次修了 (実際)
2013年12月1日
研究の完了 (実際)
2013年12月1日
試験登録日
最初に提出
2012年2月6日
QC基準を満たした最初の提出物
2012年2月8日
最初の投稿 (見積もり)
2012年2月9日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月10日
QC基準を満たした最後の更新が送信されました
2021年3月9日
最終確認日
2021年3月1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
- NA_00049467
- 3R01MH085048-03S1 (米国 NIH グラント/契約)
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。