Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)
2021年3月9日 更新者：Rebecca Landa、Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
A Comprehensive Approach to Intervention for Toddlers at Risk for ASD
This research is being done to test the effectiveness of an early intervention model for very young children at high risk for autism spectrum disorders (ASD) and their families.
If children show improvement in this intervention, the investigators hope that the availability of public services of this type will be increased.
Children between 11 months and 21 months old with Autism Spectrum Disorders, or with social and communication delays that indicate high risk for Autism Spectrum Disorders, and their parents may join the study.
Treatment must start prior to the second birthday.
調査の概要
研究の種類
介入
入学 (実際)
49
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
11ヶ月～1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:
- Children will be ascertained between 11 months and 21 months of age
- Must be able to enter the study prior to their second birthday
- Must then pass an eligibility assessment to determine whether the child meets criteria for ASD and thus qualifies for the study. This assessment will consist of the Baby ADOS and the Mullen Scales of Early Learning. Children must meet criteria for ASD or autism on the ADOS, score more than one standard deviation below the mean on the Receptive or Expressive Language scale of the MSEL, and have a clinical judgment of ASD to be eligible for enrollment into treatment.
- Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months
- The parent (or other primary caregiver, such as grandparent) in the Parent Enrichment/Training condition must agree to attend the training sessions
Exclusion Criteria:
- Fail hearing or vision screening (by pediatrician's office, audiologist, or ophthalmologist)
- Family's first language being other than English (language measures are normed on English speakers, putting non-English speakers at a disadvantage. In addition, the treatment is delivered in English. Children from non-English speaking homes may not make progress, but for reasons other than the efficacy of the intervention.)
- Head injury (because this may cause some of the symptoms, which may not be due to autism and therefore we would not be able to assess the effects of the intervention on autism)
- Identified reason for the autism (e.g., fragile X syndrome, Rett syndrome, Tuberous Sclerosis)
- Inability of the family to attend the playgroup sessions and parent trainings
- Parents whose hearing or vision is not within normal limits after correction (e.g., hearing aid, glasses)
- Parents with developmental delays, language or learning impairments, or a psychiatric diagnosis IF the impairment would interfere with parent training (PI will assess on a case by case basis by talking to the parent)
- Foster children
- Refusal to allow videotaping of the children's assessments or intervention or to allow videotaped footage to be used for teaching purposes.
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：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 |
|---|---|
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実験的：Playgroup and Parent Training
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The playgroup will be conducted at our center and focuses on providing an invigorating learning environment in which emerging skills/knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally.
Learning with and through peers, provides the opportunity to address abnormal peer relationships for developmental level.
Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement we offer the children experiences that they would not otherwise have.
Parent training sessions will focus on strategies aimed at improving child social engagement and communication.
Parent education sessions will focus on topics related to autism, learning styles, interventions, and resources.
The 1-2 hour individual therapeutic sessions with parent training in the home or clinic (1x every week over six months) are based on our own program which is in development.
This program focuses on teaching parents how to encourage social and communication skills in their toddlers and also provides comprehensive information about development.
Sessions will focus on knowledge of autism, current access to services, general knowledge of strategies used to facilitate child development, advocacy, knowledge of how to access services, and coping strategies.
他の名前：
In the once-a-week 1 to 2 hour parent training/enrichment, we will ask parents to target specific play and care routines in which they may stimulate their child's development in the ways identified by the therapist.
These stimulation times may be provided by the parents, other family members, friends, volunteers or hired assistants.
Parents will be encouraged to have their child in direct skill-enhancing engagement for 1-2 hour per day.
The therapist will work with the family to identify times during the day that best lend themselves to accomplishing this goal.
他の名前：
|
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アクティブコンパレータ：Parent Training
|
The 1-2 hour individual therapeutic sessions with parent training in the home or clinic (1x every week over six months) are based on our own program which is in development.
This program focuses on teaching parents how to encourage social and communication skills in their toddlers and also provides comprehensive information about development.
Sessions will focus on knowledge of autism, current access to services, general knowledge of strategies used to facilitate child development, advocacy, knowledge of how to access services, and coping strategies.
他の名前：
In the once-a-week 1 to 2 hour parent training/enrichment, we will ask parents to target specific play and care routines in which they may stimulate their child's development in the ways identified by the therapist.
These stimulation times may be provided by the parents, other family members, friends, volunteers or hired assistants.
Parents will be encouraged to have their child in direct skill-enhancing engagement for 1-2 hour per day.
The therapist will work with the family to identify times during the day that best lend themselves to accomplishing this goal.
他の名前：
|
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 |
|---|---|---|
|
Developmental Level
時間枠：3 months into treatment, 6 months into treatment, and 6 months after treatment ends
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Using the Mullen Scales of Early Learning to assess.
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3 months into treatment, 6 months into treatment, and 6 months after treatment ends
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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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Communication
時間枠：3 months after treatment starts
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Using Communication and Symbolic Behavior Scales to assess.
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3 months after treatment starts
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Communication
時間枠：6 months into treatment
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Using Communication and Symbolic Behavior Scales to assess.
|
6 months into treatment
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Communication
時間枠：6 months after treatment ends
|
Using Communication and Symbolic Behavior Scales to assess.
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6 months after treatment ends
|
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Presence and Severity of Autism
時間枠：3 months after treatment starts
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Using Autism Diagnostic Observation Schedule to assess.
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3 months after treatment starts
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Presence and Severity of Autism
時間枠：6 months into treatment
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Using Autism Diagnostic Observation Schedule to assess.
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6 months into treatment
|
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Presence and Severity of Autism
時間枠：6 months after treatment ends
|
Using Autism Diagnostic Observation Schedule to assess.
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6 months after treatment ends
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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。
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
- Keen D, Rodger S, Doussin K, Braithwaite M. A pilot study of the effects of a social-pragmatic intervention on the communication and symbolic play of children with autism. Autism. 2007 Jan;11(1):63-71. doi: 10.1177/1362361307070901.
- Solomon R, Necheles J, Ferch C, Bruckman D. Pilot study of a parent training program for young children with autism: the PLAY Project Home Consultation program. Autism. 2007 May;11(3):205-24. doi: 10.1177/1362361307076842.
- Howlin P, Gordon RK, Pasco G, Wade A, Charman T. The effectiveness of Picture Exchange Communication System (PECS) training for teachers of children with autism: a pragmatic, group randomised controlled trial. J Child Psychol Psychiatry. 2007 May;48(5):473-81. doi: 10.1111/j.1469-7610.2006.01707.x.
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
2008年1月1日
一次修了 (実際)
2011年12月1日
研究の完了 (実際)
2011年12月1日
試験登録日
最初に提出
2010年7月21日
QC基準を満たした最初の提出物
2010年8月10日
最初の投稿 (見積もり)
2010年8月11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_00006553
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。