Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder
2020年9月2日 更新者：University of California, Davis
Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder- Infant TeleHelp Study
Caregiver coaching will be provided using telehealth technology, in order to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.
調査の概要
詳細な説明
Ideally, all caregivers with an infant identified with concern for ASD would have immediate access to good quality caregiver coaching provided in the most natural environment possible.
However, this is currently not the case for the majority of families.
There are no empirically validated treatment programs for infants showing ASD risk.
The proposed research project will use Applied Behavior Analysis-based single-subject experimental designs to further develop a promising caregiver-mediated intervention designed for infants showing early signs of ASD.
Caregiver coaching will be provided using telehealth technology, in order to maximize recruitment opportunities and to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.
研究の種類
介入
入学 (実際)
12
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
-
-
California
-
Sacramento、California、アメリカ、95834
- MIND institute
-
-
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
5ヶ月～1年 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Infants must exhibit early symptoms of ASD as indicated by a combination of Autism Observation Scale for Infants (AOSI) scores of 7 or higher
- and Infant Toddler Checklist (ITC) scores in the autism concern range
- Expression of clinical concern about ASD risk by the assessor and caregiver
- Caregivers must be identified as the infants' primary caregivers
- Caregivers be English speaking
- Caregivers must have access to wired or wireless network technology to access the internet in their homes.
Exclusion Criteria:
- Infants may not have had significant abnormalities in the pre-, peri-, and postnatal period or gestational age younger than 34 weeks
- Infants may not have serious medical conditions involving repeated or lengthy hospitalizations, head injuries, seizures, cerebral palsy or impaired hand use
- Infants may not have multiple daily administrations of medical treatment (e.g., nebulizers daily)
- Infants may not have known genetic syndrome associated with ASD (e.g., fragile X syndrome) Infants may not have moderate to severe visual, auditory, or motor impairments
- A caregiver may be excluded from participation if the caregiver is engaging in the majority of all possible caregiver treatment target behaviors at therapeutic levels during intake (Fidelity of Implementation scores of 80% or higher on each caregiver target behavior).
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：なし
- 介入モデル：順次割り当て
- 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 |
|---|---|
|
実験的：infant telehelp condition
caregiver coaching to improve infant behaviors that indicate they are at risk for autism spectrum disorder
|
Adapted from Early Start Denver Model (ESDM), a naturalistic developmental behavioral intervention
|
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 |
|---|---|---|
|
Child Behaviors Targeted by Intervention
時間枠：7 months
|
Treatment-targeted child behaviors (e.g., visual fixations on objects, abnormal repetitive behaviors, lack of age-appropriate phonemic development, lack of coordination of gaze, affect, and voice in reciprocal, turn-taking interactions) will be coded from 10-minute caregiver-infant dyad intervention video probes taken throughout all phases of the study.
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7 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Autism Observation Scale for Infants
時間枠：7 months
|
(AOSI; Bryson et al., 2006) The AOSI will be administered by caregivers at intake and exit.
During the AOSI, infants are engaged in semi-structured play and systematic presses are designed to assess various target behaviors, including visual tracking and attention disengagement, coordination of eye gaze and action, imitation, affective responses, early social-communicative behaviors, behavioral reactivity, and sensory-motor development.
|
7 months
|
|
Ages and Stages Questionnaires, 3rd Edition
時間枠：7 months
|
(ASQ-3; Squires & Bricker, 2015) The ASQ-3 are a series of questionnaires completed by a child's caregiver designed to assess the developmental performance of infants and children ages 1-66 months across five developmental areas: communication, gross motor, fine motor, problem solving, and personal-social.
The ASQ-3 takes approximately 15 minutes to be completed.
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7 months
|
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Individual Growth and Development Indices
時間枠：7 months
|
(IGDIs; Carta et al., 2010) IGDIs were developed to gather very frequent assessment of child developmental progress.
We will use the Early Communication Index, ECI, and the Early Problem Solving Index, EPSI, domains appropriate for ages 5 to 50 mos.
Two 6-minute semi-structured and video recorded play procedures will be carried out at intake and exit.
|
7 months
|
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Vineland Adaptive Behavior Scales, 2nd edition
時間枠：7 months
|
(VABS-II; Sparrow et al., 2005) The VABS-II consists of four domains of adaptive behavior: communication, self-care, social, and motor skills.
The VABS-II is a semi-standardized caregiver questionnaire or interview designed to assess children's behavior in real life, everyday settings.
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7 months
|
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Parent Satisfaction Rating
時間枠：7 months
|
(Charlop-Christy & Carpenter, 2000) This is a measure of social validity, or acceptability, of the experimental treatment, to caregivers.
This scale will be administered to the caregivers at intake and exit.
This tool allows caregivers to rate the ease of implementation in the home and their opinions concerning treatment utility.
|
7 months
|
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Working Alliance Scale for Interventions with Children
時間枠：7 months
|
(Davis et al., 2006).
These measures will be administered to the caregivers at intake and exit and will be used to describe the response of the families to the experimental intervention, and thus constitutes another measure of social validity.
|
7 months
|
|
Caregiver Fidelity of Treatment Implementation
時間枠：7 months
|
Caregiver fidelity of implementation (FI) of the Infant Start intervention will be coded from 10-minute caregiver-child dyad intervention video probes to determine caregivers' FI of intervention techniques over the course of the study.
The fidelity tool involves having experts in Infant Start rate caregiver use of each of the intervention strategies on a 1-5 Likert rating scale, with a code of "1" meaning the caregiver did not implement the technique throughout the session and a code of "5" meaning the caregiver implemented the technique correctly throughout the session.
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7 months
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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。
捜査官
- 主任研究者：Sarah Dufek, PhD、UC Davis
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 (実際)
2018年7月1日
一次修了 (実際)
2019年9月18日
研究の完了 (実際)
2019年10月1日
試験登録日
最初に提出
2018年6月25日
QC基準を満たした最初の提出物
2018年7月17日
最初の投稿 (実際)
2018年7月19日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月4日
QC基準を満たした最後の更新が送信されました
2020年9月2日
最終確認日
2020年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1249018
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?
いいえ
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いいえ
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いいえ
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