Effectiveness of DIR/Floortime™ in Children With Autism Spectrum Disorder (DIR-ASD)
Efficacy of Integrated DIR/Floortime™ for Children With Autism Spectrum Disorder: A Randomized Controlled Trial
調査の概要
詳細な説明
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition that significantly affect emotional development, communication, and social interaction. Although conventional interventions target specific developmental domains, many children continue to experience challenges in functional emotional capacities and daily living skills.
Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ is a relationship-based intervention that promotes emotional regulation, communication, social engagement, and higher-order thinking through child-led, developmentally appropriate interactions. This study investigates the effectiveness of integrating DIR/Floortime™ with standard therapeutic services.
This study uses a parallel-group randomized controlled design. Eligible children aged 4-12 years diagnosed with ASD are randomly assigned to either an intervention group receiving DIR/Floortime™ plus standard therapies or a control group receiving standard therapies alone. Outcomes are measured before and after the intervention using the Functional Emotional Assessment Scale (FEAS) and the Vineland Adaptive Behavior Scales (VABS). The findings are expected to contribute evidence regarding the effectiveness of DIR/Floortime™ in improving functional emotional development and adaptive behavior among children with ASD and IDD.
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
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Punjab Province
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Gujranwala、Punjab Province、パキスタン
- SEND Therapy Center
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Children aged 4-12 years.
- Clinical diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5-TR criteria according to DSM-5-TR criteria.
- Mild to moderate ASD severity.
- Receiving routine therapeutic services.
- Eligible to participate in the 10-week DIR/Floortime™ intervention.
- Parent or legal guardian willing to provide written informed consent.
Exclusion Criteria:
- Severe Autism Spectrum Disorder that would prevent participation in the intervention.
- Severe visual, hearing, or physical impairments interfering with assessment or intervention.
- Major neurological or genetic disorders that could affect study participation.
- Serious medical or psychiatric conditions requiring intensive treatment.
- Participation in another intervention study during the study period.
- Parent or legal guardian unwilling to provide informed consent.
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：単一グループの割り当て
- 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 |
|---|---|
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実験的：DIR/Floortime + Standard Therapy
Participants received Integrated DIR/Floortime™ in addition to their ongoing standard therapies.
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Participants received Integrated DIR/Floortime™ intervention for 10 weeks in addition to their ongoing standard therapies.
The intervention focused on promoting functional emotional development, communication, social interaction, and adaptive functioning through child-led, relationship-based sessions conducted according to the DIR/Floortime™ model.
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アクティブコンパレータ：Standard Therapy
Participants continued to receive standard therapies without DIR/Floortime
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Participants continued to receive routine standard therapeutic services without the addition of DIR/Floortime™ during the 10-week study period.
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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 |
|---|---|---|
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Socialization Skills
時間枠：Baseline and Week 10
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Change in Socialization Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Socialization domain Growth Scale Values (GSVs).
GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
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Baseline and Week 10
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Communication Skills
時間枠：Baseline and Week 10
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Change in Communication Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Communication domain Growth Scale Values (GSVs).
GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
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Baseline and Week 10
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Daily Living Skills
時間枠：Baseline and Week 10
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Change in Daily Living Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Daily Living Skills domain Growth Scale Values (GSVs).
GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
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Baseline and Week 10
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Functional Emotional Development
時間枠：Baseline and Week 10
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Change in functional emotional development measured using the Functional Emotional Assessment Scale (FEAS).
FEAS items are scored from 0 to 2, with higher scores indicating better functional emotional development.
Symbolic, Sensory, and Examiner scores are assessed.
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Baseline and Week 10
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協力者と研究者
スポンサー
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- GIFT/PSY/MS/2025/001
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
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。