自閉症の若年者の自己調節に馬を統合する作業療法の予備的有効性
自閉症スペクトラム障害の若者の自己調整に馬を統合する作業療法の予備的有効性
The goal of this clinical trial is to learn about occupational therapy integrating horses for autistic youth. The main questions it aims to answer are:
- Does occupational therapy integrating horses improve self-regulation in autistic youth
- Does occupational therapy integrating horses affect salivary cortisol and alpha-amylase
Participants will receive 10 weeks of occupational therapy, and will be asked to provide saliva samples each week.
Researchers will compare occupational therapy integrating horses to occupational therapy in a clinic to see if integrating horses affects self-regulation.
調査の概要
詳細な説明
The goal of this project is to quantify the unique benefits of integrating horses in occupational therapy compared to occupational therapy in a clinic (i.e., OTEE HORS vs. OT Clinic) for improving self-regulation in youth with ASD.
To address both aims we will randomize 64 youth with ASD ages 6-11 years old to OTEE HORS or OT clinic.
Specific Aim 1: Examine the preliminary efficacy of OTEE HORS compared to OT Clinic on self-regulation. Hypotheses: The OTEE HORS group will demonstrate significantly larger improvements than the OT Clinic group in five domains of self-regulation (hyperactivity [primary], irritability, emotional reactivity, dysphoria, and individual goal attainment).
Specific Aim 2: Identify potential physiological mechanisms that explain how integration of horses in occupational therapy impacts self-regulation in youth with ASD. Hypotheses 2A & B: The OTEE HORS group will demonstrate significantly larger decreases in salivary cortisol after each 60-minute therapy session and after the 10-week treatment course in comparison to the OT Clinic group. Hypotheses 2C & 2D: The OTEE HORS group will demonstrate significantly greater increases in salivary alpha-amylase after each 60-minute therapy session, and significantly greater decreases in salivary alpha-amylase over time as measured after the 10-week treatment course in comparison to the OT Clinic group. Exploratory Hypothesis 2E: Changes in physiological measures will significantly correlate with changes in Aim 1 behavioral measures.
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
-
-
Colorado
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Denver、Colorado、アメリカ、80216
- Temple Grandin Equine Center
-
-
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:
- meet clinical cut-offs for ASD on the Autism Diagnostic Observation Schedule, Second Edition(ADOS-2) and Social Communication Questionnaire (≥ 11)
- nonverbal IQ≥65 on Leiter International Performance Scale Third Edition (Leiter-3)
- verbally fluent defined by meeting standard administration criteria for ADOS-2 module 3
- score >10 on the irritability subscale of the aberrant behavior checklist
- able to tolerate a helmet and ride a horse for 10 minutes while following safety rules
- and able to provide a saliva sample
Exclusion Criteria:
- weigh more than 200 pounds
- smoke or regularly use steroids
- receive outpatient occupational therapy
- have 10+ hours horseback riding experience in the previous 6 months
- history of animal abuse or phobia of horses
- have a sibling previously enrolled in the study
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：並列代入
- 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：Occupational Therapy Integrating Horses
10 weeks of occupational therapy focused on self-regulation skills, provided while participants are riding horses |
10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses |
|
アクティブコンパレータ：Occupational Therapy in a Clinic
10 weeks of occupational therapy focused on self-regulation skills, provided in a traditional clinic environment |
10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic |
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 Hyperactivity
時間枠：Week 1 & Week 10
|
The Hyperactivity subscale of the Aberrant Behavior Checklist, Second Edition (ABC-2) measures parent/caregiver-reported hyperactive and impulsive behaviors, including excessive activity, impulsivity, and difficulty remaining still or attending. The subscale consists of 16 items, with total scores ranging from 0-48. Higher scores indicate greater hyperactivity and more severe behavioral difficulties, while lower scores indicate less hyperactivity and better behavioral functioning. Item scores are summed to produce the subscale score. |
Week 1 & Week 10
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Irritability
時間枠：Week 1 & Week 10
|
The Irritability subscale of the Aberrant Behavior Checklist, Second Edition (ABC-2) measures behaviors associated with irritability, including aggression, self-injury, tantrums, and mood instability. The subscale consists of 15 items, with total scores ranging from 0-45. Higher scores indicate greater irritability and more severe behavioral difficulties, while lower scores indicate less irritability and better behavioral functioning. Items are rated based on the presence and severity of behaviors, and item scores are summed to produce the subscale score. |
Week 1 & Week 10
|
|
Change in Emotional Reactivity
時間枠：Week 1 & Week 10
|
The Emotional Reactivity subscale of the Emotion Dysregulation Inventory (EDI) measures the tendency to experience intense, rapidly escalating, and prolonged negative emotional responses. T-scores are standardized scores derived from the raw Emotional Reactivity score and have a mean of 50 and standard deviation of 10 in the normative sample. Higher T-scores indicate greater emotional reactivity and more severe emotion dysregulation, while lower T-scores indicate less emotional reactivity and better emotional regulation. |
Week 1 & Week 10
|
|
Change in Dysphoria
時間枠：Week 1 & Week 10
|
The Dysphoria subscale of the Emotion Dysregulation Inventory (EDI) measures symptoms of negative mood, including sadness, hopelessness, and emotional distress. T-scores are standardized scores derived from the raw Dysphoria score and have a mean of 50 and standard deviation of 10 in the normative sample. Higher T-scores indicate greater dysphoria and more severe negative mood symptoms, while lower T-scores indicate less dysphoria and better emotional well-being. |
Week 1 & Week 10
|
|
Change in Concentration of Salivary Cortisol
時間枠：Pre-session, Post-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
|
Change in Concentration of Salivary Cortisol from before-session, after-session, and 20 mins after-session. Saliva samples from Weeks 2, 6, and 10 at pre-session, post-session, and post-session +20, were assayed for cortisol content and included in the linear mixed model analyses. |
Pre-session, Post-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
|
|
Change in Concentration of Salivary Alpha-amylase
時間枠：Pre-session, Within-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
|
Change in concentration of salivary alpha-amylase from before-session, during-session, and 20 mins after-session. Saliva samples from Weeks 2, 6, and 10 at pre-session, within-session, and post-session +20, were assayed for alpha-amylase content and included in the linear mixed model analyses. |
Pre-session, Within-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
|
|
Emotional Awareness Goal Attainment
時間枠：Week 10
|
Attainment of individualized emotional awareness goal. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal, level 0 indicates goal was met. |
Week 10
|
|
Self-regulation Tool Identification Goal Attainment
時間枠：Week 10
|
Attainment of individualized goal related to identifying self-regulation tools. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal, level 0 indicates goal was met. |
Week 10
|
|
Self-regulation Tool Use Goal Attainment
時間枠：Week 10
|
Attainment of individualized goal related to using self-regulation tools. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal, level 0 indicates goal was met. |
Week 10
|
協力者と研究者
協力者
捜査官
- 主任研究者：Brittany C Peters, PhD、Colorado State University
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 (実際)
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 (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
追加の関連 MeSH 用語
その他の研究ID番号
- 4049
- 1R21HD109957-01 (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
De-identified data will be shared in an appropriate data repository, such as the "Data and Specimen Hub" (DASH) or the "National Database for Autism Research" (NDAR). Data will be shared no later than the acceptance for publication of the main findings from the final dataset. Salimetrics will discard saliva samples after testing, and therefore saliva samples will not be available for sharing.
IPD 共有時間枠
We will share in an appropriate data repository indefinitely, no later than the acceptance for publication of the main findings from the final dataset
IPD 共有サポート情報タイプ
- 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
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。