Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder (DIR-IDD)
Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder: A Randomized Controlled Trial
調査の概要
詳細な説明
Intellectual Developmental Disorder (IDD) is characterized by significant limitations in intellectual functioning and adaptive behavior, affecting conceptual, social, and practical skills. Although conventional therapeutic interventions support developmental progress, many children continue to experience challenges in communication, social interaction, daily living skills, and functional emotional development. The Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ model is a relationship-based intervention designed to enhance emotional, social, and developmental capacities through child-led interactions.
This study is a parallel-group randomized controlled trial evaluating the effectiveness of Integrated DIR/Floortime™ in children with IDD. Participants aged 4-12 years will be randomly assigned to either an experimental group receiving DIR/Floortime™ in addition to standard therapy or a control group receiving standard therapy alone. The intervention will be delivered over a period of 10 weeks.
The primary outcomes include communication, socialization, daily living skills, and functional emotional development. These outcomes will be measured using the Vineland Adaptive Behavior Scales (VABS) and the Functional Emotional Assessment Scale (FEAS) at baseline and after completion of the 10-week intervention. The findings will contribute to the evidence regarding the effectiveness of DIR/Floortime™ for children with Intellectual Developmental Disorder.
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 Intellectual Developmental Disorder (IDD) according to DSM-5-TR criteria.
- Mild to moderate intellectual developmental impairment.
- Receiving routine therapeutic services.
- Able to participate in the 10-week DIR/Floortime™ intervention and study assessments.
- Written informed consent obtained from a parent or legal guardian.
Exclusion Criteria:
- Profound or severe Intellectual Developmental Disorder preventing meaningful participation in the intervention.
- Severe visual, hearing, or physical impairments that would interfere with assessments 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 written 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 |
|---|---|
|
実験的：DIR/Floortime + Standard Therapy
Participants receive Integrated DIR/Floortime™ in addition to their routine standard therapeutic services for 10 weeks.
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Integrated Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ intervention delivered for 10 weeks in addition to standard therapy
|
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アクティブコンパレータ：Standard Therapy
Participants continue to receive routine standard therapeutic services without the addition of DIR/Floortime™ for 10 weeks.
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Routine therapeutic services provided without 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 |
|---|---|---|
|
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.
|
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.
|
Baseline and Week 10
|
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Daily Living Skills
時間枠：Baseline and Week 10
|
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.
|
Baseline and Week 10
|
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Functional Emotional Development
時間枠：Baseline and Week 10
|
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
|
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
追加の関連 MeSH 用語
その他の研究ID番号
- GIFT/PSY/MS/2025/001B
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
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