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ASD青年の精神医学集団における治療的乗馬介入効果の生理学的メカニズム

2026年7月24日 更新者：University of Colorado, Denver

自閉症スペクトラム障害の若者の精神医学集団における即時および長期の治療的乗馬介入効果に関連する生理的作用機序

この無作為化対照試験 (RCT) は、ASD の若者、特に併発する精神障害を持つ若者に以前に観察された治療的乗馬 (THR) の根底にあるメカニズムを評価し、耐久性、用量、およびサブ集団に関する情報を精緻化することを目指しています。介入の効果。

調査の概要

状態

完了

条件

介入・治療

詳細な説明

この無作為対照試験 (RCT) は、唾液コルチゾール、心臓血管、および皮膚電気活動の生理学的反応パターンが、以前に観察された重要な結果 (すなわち、過敏性と活動亢進の減少、社会的およびコミュニケーションの改善)、および追加の結果を説明するという仮説をテストします (情動調節 介護者 生活の質と危機 メンタルヘルスケアの使用)、6-16 歳の青少年。 ASD と同時発生する精神医学的診断を伴う 10 週間の手動化された THR 介入に無作為化され、馬のない納屋活動 (BA) 対照 (目的 1) と比較されました。 介入期間（目的2）の6か月後に、BAコントロールグループと比較して、THRグループの目的1の結果の持続性を評価します。 最後に、THR および BA 群の効果サイズの違いを (a) 10 週間の待機リスト対照群と比較することにより、THR および BA 介入の用量および部分母集団への影響を調査します。 (b) ハイブリッド介入グループ (5 週間の BA に続いて 5 週間の THR); （c）精神科入院後に無作為化されたTHR研究集団のサブサンプル（目的3）。

研究の種類

介入

入学 (実際)

236

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

  • アメリカ
    • Colorado
      • Aurora、Colorado、アメリカ、80218
        • University of Colorado Anschutz Medical Campus
    • Maine
      • Portland、Maine、アメリカ、04102
        • Maine Health

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

6年～17年 (子)

健康ボランティアの受け入れ

はい

説明

包含基準:

  • 文書化されたASD診断と併発する精神障害
  • ABC過敏性サブスケールスコア≧8
  • Leiter-III非言語的IQ≧40
  • 症状基準スコア (CASI-5 の DSM-V (気分、不安、または ADHD 診断) に必要な症状の最小数) を満たす
  • SCQ (≥ 11) および ADOS-2 で ASD カットオフを満たす
  • 独立した観察を維持するために、家族ごとにASDを持つ子供は1人だけです
  • 一貫した介護者 (すなわち、親または法定後見人) が研究成果測定を完了します。

除外基準:

  • 参加を妨げる医学的または行動上の問題
  • 州の病棟
  • ライディングセンターの画面で、かなりのライディング経験があると判断された
  • 喫煙または経口、吸入、または局所ステロイドの定期的な使用、コルチゾールレベルに影響を与えることが知られている要因
  • 乗馬センターの安全方針により、体重が 200 ポンド以上の参加者は除外されます
  • 参加者は、THR 効果の 6 か月の維持に関するパイロットの証拠を考慮して、マウント EAAT に最後に従事した時点から少なくとも 6 か月が経過するまで、ベースライン評価を開始することはできません。

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：独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし：順番待ちリスト
待機リスト グループに割り当てられた者は、10 週間の待機期間中、馬に関連する介入を受けません。 この待機期間と事後評価の完了後、この状態の参加者はハイブリッド グループを開始します (ハイブリッド アームを参照)。
実験的：セラピー乗馬
この Arm は、THR インストラクターが率いる 10 週間の 1 時間の小グループ (参加者 2 ～ 4 人) です。 このグループには、研究の THR マニュアルに概要が記載されている馬術スキルを学ぶための 45 分間の馬上活動が含まれます。 唾液コルチゾールを収集するためのグループ時間は午後 1 時から 5 時までとなります。 毎週、参加者は皮膚電気活動と心拍数モニタリング装置の両方を装着するという一貫したルーチンに従い、授業前にグループアートテーブルに座り、その後、研究担当者が参加者に長さ10cmのフォーム綿棒を舌の下に置くように指示します。 1分タイマーを見ながら1分間。 その後、参加者は乗馬ヘルメットをかぶって乗馬アリーナに入ります。 毎週、THR 介入終了後、参加者は再びグループと一緒にアートテーブルに 5 分間座り、その後再度唾液サンプルを採取します。
他の：セラピー乗馬
ホースセラピー
他の名前：
  • 馬介助活動
アクティブコンパレータ：納屋でのアクティビティ
このアームは、THR インストラクターが指導し、メンタルヘルスまたは作業療法の提供者が共同指導する 10 週間の 1 時間の小グループ (参加者 2 ～ 4 人) です。 参加者にはボランティアが 1 名割り当てられ、乗馬センターでは馬との物理的な接触はなく、遠くから馬を眺めるだけになります。 等身大の馬のぬいぐるみがあり、BA 学習マニュアルに従って毎週のトピックに関連した実践学習が行われます。 唾液コルチゾールを収集するためのグループ時間は午後 1 時から 5 時までとなります。 毎週、参加者は皮膚電気活動と心拍数モニタリング装置の両方を装着するという一貫したルーチンに従い、授業前にグループアートテーブルに座り、その後、研究担当者が参加者に長さ10cmのフォーム綿棒を舌の下に置くように指示します。 1分タイマーを見ながら1分間。 BA 介入終了後、毎週、参加者は再びグループと一緒にアートテーブルに 5 分間座り、その後再度唾液サンプルを採取します。
他の：納屋の活動
馬術班
他の名前：
  • ホースコントロールなし
実験的：ハイブリッド
待機リストのアームとポストアセスメントを完了した参加者は、午後 1 時から午後 5 時の間にハイブリッド グループを開始します。 このグループは、THR インストラクターが指導し、メンタルヘルス カウンセラーまたは OT が共同指導する、5 週間 1 時間の BA 少人数グループ (参加者 2 ～ 4 人) で構成されます。 参加者にはボランティアが 1 名割り当てられ、乗馬センターでは馬との物理的な接触はなく、遠くから馬を眺めるだけです。 等身大の馬のぬいぐるみがあり、BA 学習マニュアルに従って毎週のトピックを実践的に学習できます。 グループ。 その後、参加者は、THR インストラクターが率いる小グループ (参加者 2 ～ 4 名) での 5 週間の治療的乗馬を完了します。 このグループには、馬術スキルを学ぶための 45 分間の馬上アクティビティが含まれます。その後、THR マニュアルに従って、15 分間の馬に乗らない馬の手入れと馬具のアクティビティが含まれます。 参加者には割り当てられた馬とボランティアが割り当てられます。
他の：ハイブリッド
グラウンドと乗馬のアクティビティ
他の名前：
  • 馬介助活動

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
Aberrant Behavior Checklist-Community (ABC-C) - Baseline
時間枠：Baseline
The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e. Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale. THIS MEASURE DOES NOT GENERATE A TOTAL SCORE. Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems. The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
Baseline
Aberrant Behavior Checklist-Community (ABC-C) - End of Treatment
時間枠：End of Treatment
The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e. Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale. THIS MEASURE DOES NOT GENERATE A TOTAL SCORE. Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems. The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
End of Treatment
Aberrant Behavior Checklist-Community (ABC-C) - 6 Months Post Treatrment
時間枠：6 months post intervention
The ABC is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e. Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale. THIS MEASURE DOES NOT GENERATE A TOTAL SCORE. Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems. The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
6 months post intervention
Social Responsiveness Scale™, Second Edition - End of Treatment
時間枠：End of Treatment
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD. THIS STUDY USED RAW SCORES FOR ANALYSES. FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME. Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134. Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19. Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of g 28. Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26. Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
End of Treatment
Social Responsiveness Scale™, Second Edition - 6 Months Post Treatment
時間枠：6 months post intervention
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD. THIS STUDY USED RAW SCORES FOR ANALYSES. FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME. Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134. Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19. Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28. Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26. Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
6 months post intervention
Emotion Dysregulation Inventory (EDI) - Baseline
時間枠：Baseline
The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately. The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions. The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness. Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here). The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
Baseline
Emotion Dysregulation Inventory (EDI) - End of Treatment
時間枠：End of Treatment
The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately. The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions. The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness. Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here). The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
End of Treatment
Emotion Dysregulation Inventory (EDI) - 6 Months Post Treatment
時間枠：6 months post intervention
The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately. The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions. The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness. For each scale (Reactivity and Dysphoria), raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here). The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
6 months post intervention
Systematic Analysis of Language Transcripts (SALT) - Baseline
時間枠：Baseline
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD. The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database. A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment. Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
Baseline
Systematic Analysis of Language Transcripts (SALT) - End of Treatment
時間枠：End of Treatment
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD. The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database. A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment. Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
End of Treatment
Systematic Analysis of Language Transcripts (SALT) - 6 Months Post Treatment
時間枠：6 months post treatment
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD. The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database. A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment. Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
6 months post treatment
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - Baseline
時間枠：Baseline
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale. Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here. Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
Baseline
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - End of Treatment
時間枠：End of Treatment
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale. Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here. Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
End of Treatment
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - 6 Months Post Treatment
時間枠：6 months post intervention
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale. Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
6 months post intervention
Social Responsiveness Scale™, Second Edition - Baseline
時間枠：Baseline
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD. The Social Responsiveness Scale™-Second Edition generates raw scores and t-scores for both the combined total score as well as for each of the 5 subscales (social awareness, social cognition, social communication, social motivation, and restricted/repetitive behaviors). NOTE: THIS STUDY USED THE RAW SCORES FOR ANALYSES. The combined Social Responsiveness Scale™-Second Edition total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134. HIGHER SCORES ON THIS SCALE INDICATE WORSE OUTCOMES. The Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19. HIGHER SCORES ON THIS SUBSCALE INDICATE WORSE OUTCOMES. The Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28. HIGHER SCORES ON THIS SUBSCALE.
Baseline

その他の成果指標

結果測定
メジャーの説明
時間枠
Salivary Cortisol - Baseline Baseline
時間枠：Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before (i.e., "Pre-session") and 20 minutes after (i.e., "Post-Session) each THR or BA group session weeks 1-10. Salivary cortisol collected pre- and -post intervention activities were analyzed separately.
Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
Salivary Cortisol - Mid-Point
時間枠：Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10. Salivary cortisol collected pre- and -post intervention activities were analyzed.
Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
Salivary Cortisol - End of Treatment
時間枠：Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10. Salivary cortisol collected pre- and -post intervention activities were analyzed.
Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
Heart Rate Variability - Baseline
時間枠：Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
The Shimmer3 cardiac (ECG) monitor was used in this study. This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion. The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively. It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125 It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing. Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson. Unit of measure is ms log-10 transformed.
Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
Heart Rate Variability - Mid-point
時間枠：Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
The Shimmer3 cardiac (ECG) monitor was used in this study. This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion. The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively. It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125 It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing. Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson. Unit of measure is ms log-10 transformed.
Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
Heart Rate Variability - End of Treatment
時間枠：Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
The Shimmer3 cardiac (ECG) monitor was used in this study. This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion. The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively. It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125 It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing. Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson. Unit of measure is ms log-10 transformed.
Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
Electrodermal Activity -- Baseline
時間枠：Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes. As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used. EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range. Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile. The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry. Participants' Shimmer3 EDA assessments were measured during the intervention lesson. Unit of measure is microsiemens.
Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
Electrodermal Activity - Mid-point
時間枠：Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes. As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used. EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range. Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile. The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry. Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson. Unit of measure is microsiemens.
Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
Electrodermal Activity - End of Treatment
時間枠：Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).
The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes. As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used. EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range. Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile. The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry. Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson. Unit of measure is microsiemens.
Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).

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。

スポンサー

University of Colorado, Denver

協力者

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Boston Children's Hospital
Baylor University
Colorado State University
Riding To The Top Therapeutic Riding Center
Hearts and Horses Therapeutic Riding Center
Salimetrics, LLC
Maine Health/Spring Harbor Hospital

捜査官

  • 主任研究者：Robin L Gabriels, Psy.D.、University of Colorado Anzchutz Medical Campus

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)

2020年12月22日

一次修了 (実際)

2025年2月22日

研究の完了 (実際)

2025年2月22日

試験登録日

最初に提出

2020年10月15日

QC基準を満たした最初の提出物

2020年10月22日

最初の投稿 (実際)

2020年10月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月18日

QC基準を満たした最後の更新が送信されました

2026年7月24日

最終確認日

2026年7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

  • 19-1962
  • 1R01HD097693-01A1 (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?

いいえ

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

いいえ

米国FDA規制機器製品の研究

いいえ

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