Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders
Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum (The ESI Study)
調査の概要
状態
条件
詳細な説明
Autism is a problem with normal social development and is characterized by impairments in three categories: social skills, language, and behavior. Symptoms include disinterest or inability to have normal social relationships, abnormal speech or usage of phrases, and repetitive movements or rituals; these symptoms generally emerge by 18 months of age. Autism is a spectrum disorder, meaning that its symptoms can range in severity from mild to severe. There is no cure for autism, nor is there a single known cause. There are only factors known to make it more likely for children to develop autism. These include being a male, having siblings with the disorder, having certain other disorders, or having an older father. Treatments for autism generally include therapies that help children develop social communication skills and that help structure family time and school so that parents and teachers can address particular difficulties children with autism might have. Medications may also be used to counteract anxieties or compulsive behaviors.
Research has shown that earlier interventions in children who are at risk of autism may lead to better outcomes. This study will compare two interventions for developing social communication skills in children who are at risk of autism and are between 16 and 20 months old. The parent-implemented intervention (PII) will be a more intense, individualized approach, teaching parents to embed 25 hours of social communication skills practice per week in their children's daily lives. The information, education, and support (IES) intervention will offer parents a support group and place to practice methods of helping their children learn adaptive social communication.
Participation in this study will last 18 months. Participants will be randomly assigned to first receive 9 months of either PII or IES and then receive 9 months of whichever intervention they did not receive initially. The PII intervention will involve three weekly sessions for 7 months, then two weekly sessions for 2 months. The IES intervention will involve group meetings twice monthly and offer a playground where parents can practice intervention strategies with their children. All parents will complete questionnaires about family resources and social and emotional issues before the first intervention begins, after 9 months when the intervention changes, and after 18 months when the second intervention ends. Children and parents will also be assessed once a month throughout the study on social communication, autism symptoms, developmental level, and hours spent on learned strategies or techniques outside the study visits. These assessments will involve clinical assessments of parent and child behaviors (some of which will be videotaped), tests of children's abilities, and reports by parents on strategies and techniques used outside the clinic.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Florida
-
Tallahassee、Florida、アメリカ、32306
- Florida State University
-
-
Michigan
-
Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Presence of autism risk factors and a clinical diagnosis of autism spectrum disorder based on a diagnostic evaluation conducted by the project team
- Families agree to twice monthly play group sessions for 9 months and two to three intervention sessions per week for 9 months, usually to be scheduled within workday hours
- Families agree to monthly evaluations, videotaping of intervention sessions, and weekly or monthly video checks during the 18 months of treatment
Exclusion Criteria:
- Child does not have normal hearing or adequate motor control to make simple actions, such as giving and reaching gestures
- Primary language of family is not English
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:クロスオーバー割り当て
- 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 |
|---|---|
|
実験的:ESI--Individual PII First Condition
This group will first receive the Early Social Interaction (ESI) model individual parent-implemented intervention (PII) for 9 months, followed by the ESI model group information, education, and support (IES) intervention for 9 months.
|
The PII is an intensive, individualized treatment that teaches parents how to support social communication skills in children with autism by embedding skills practice within everyday routines, activities, and places.
Participants will have three 75-minute sessions weekly with study administrators for the first 7 months of the study.
Participants will then have two sessions per week for the final 2 months of the study.
Children will also practice socialization embedded in normal activities for 25 hours a week outside of study visits.
The IES intervention provides access to a support group meeting twice monthly for children with autism and their parents.
The support group provides information to families and a playgroup where parents may practice intervention strategies under the supervision of study officials knowledgeable about autism spectrum disorders.
|
|
実験的:ESI--Group IES First Condition
The group will first receive ESI group IES condition for 9 months, followed by ESI individual PII for 9 months.
|
The PII is an intensive, individualized treatment that teaches parents how to support social communication skills in children with autism by embedding skills practice within everyday routines, activities, and places.
Participants will have three 75-minute sessions weekly with study administrators for the first 7 months of the study.
Participants will then have two sessions per week for the final 2 months of the study.
Children will also practice socialization embedded in normal activities for 25 hours a week outside of study visits.
The IES intervention provides access to a support group meeting twice monthly for children with autism and their parents.
The support group provides information to families and a playgroup where parents may practice intervention strategies under the supervision of study officials knowledgeable about autism spectrum disorders.
|
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 |
時間枠 |
|---|---|
|
Child measures of autism symptoms, social communication, developmental level, and adaptive behavior
時間枠:Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month
|
Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Parent report measures of family functioning, daily hassles, and treatment satisfaction
時間枠:Measured before treatment, at crossover, and after treatment
|
Measured before treatment, at crossover, and after treatment
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Amy M. Wetherby, PhD、Florida State University
- 主任研究者:Catherine Lord, PhD、University of Michigan
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
- R01MH077730 (米国 NIH グラント/契約)
- DDTR B2-MBA (その他の助成金/資金番号:National Institute of Mental Health)
- 1R01MH077730-01A2 (米国 NIH グラント/契約)
- 1R01MH078165-01A2 (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。