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Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)

2026年10月29日 更新者:Yale University

This study aims to test the efficacy of a parent-based approach to treating Avoidant/Restrictive Food Intake Disorder (ARFID) in children, SPACE-ARFID (Supportive Parenting for Anxious Childhood Emotions, adapted for ARFID), by comparing it to Nutritional Support (NS). The study design is a randomized controlled trial with 2 treatment arms and 3 assessment points (pre, post, and follow-up) using questionnaire data and clinical interviews.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

The primary objective is to examine if SPACE-ARFID is more efficacious than NS in reducing adolescent ARFID symptoms. The secondary objective is to examine if SPACE-ARFID produces greater change than NS in improving family accommodation and family functioning. SPACE and NS will be delivered over 16-20 weekly sessions, pre-assessment will take place before sessions begin and post-assessment will take place once sessions end, there will also be a midpoint assessment halfway through treatment (sessions 8-10) and one more follow-up assessment 6 months later.

研究の種類

介入

入学 (推定)

110

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。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Connecticut
      • New Haven、Connecticut、アメリカ、06519
        • Yale Child Study Center
        • コンタクト:

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~12年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Be between 6 and 12 years old.
  • Meet DSM-5 diagnostic criteria for ARFID, as determined by the PARDI diagnostic interview.
  • Cease all other psychotherapeutic treatment targeting eating or feeding behaviors, upon consultation with project staff and the current service provider.
  • Not currently use any psychotropic medication, unless on a stable dose for a minimum of 4 weeks prior to enrollment; no changes anticipated during the course of the study.
  • BMI at or above the 5th percentile for age and sex.
  • Have an eligible and willing participating parent (see parent exclusions below).

Exclusion Criteria:

Adolescents:

  • Meet criteria for any other DSM-5 disorder as determined by the ADIS diagnostic interview and health history form, that is sufficiently impairing or disruptive so as to make treatment focused on ARFID not feasible.
  • Have any of the following disorders: intellectual disability; bipolar disorder; schizophrenia and other psychotic disorders; and alcohol and substance use disorders, as determined by the health history form.
  • Report a suicide attempt in the last 3 months, or current suicide intent and/or plans.
  • Be a victim of past or present undisclosed abuse requiring investigation or ongoing supervision by the Department of Children and Families.
  • Not have sufficient proficiency in English to complete assessments.
  • Require a level of medical care for nutritional compromise that exceeds what can be safely provided in an outpatient setting.

Parents:

  • Have any of the following: intellectual disability; untreated bipolar disorder; untreated schizophrenia and other psychotic disorders; and untreated alcohol and substance use disorders, report a suicide attempt in the last 3 months, or current suicide intent and/or plans.
  • Not be living with the child at least 50% of the time.
  • Not have sufficient proficiency in English to complete assessments and participate in treatment.

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: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:Supportive Parenting for Anxious Childhood Emotions (SPACE)

Parent-only approach to treating anxiety disorders in adolescents delivered over 16-20 sessions.

Parent-based treatment delivered by therapist for 16-20 weekly sessions.

アクティブコンパレータ:Nutritional Support (NS)

Parent-only approach comparator arm delivered over 16-20 sessions.

Nutritional Support from Registered Dietician for 16-20 weekly sessions with parents.

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
Pica, ARFID, and Rumination Disorder Interview (PARDI-C/P)
時間枠:Weeks 1 and 16-20

This semi-structured clinical interview will assess ARFID presence and severity. Symptoms are rated on a 0 (no symptoms) to 6 (severe symptoms) scale. It yields an overall severity score and three profile scores (sensory sensitivity, lack of interest in eating or food, fear of aversive consequences). Score range = 0 to 6 with higher scores indicating greater severity.

Weeks 1 and 16-20
Nine-Item Avoidant/Restrictive Food Intake Disorder Screen - Parent and Child Report (NIAS-C/P)
時間枠:Weeks 1, 8-10, 16-20 and 6 months later

This measure is a screener of ARFID severity. It contains 9 items, each rated on a 6-point scale from 0 ("strongly disagree") to 5 ("strongly agree"). It yields a total score and three subscale scores (picky/selective eating, poor appetite/limited interest, fear of negative consequences). Total score range = 0 to 45, with higher scores indicating greater severity.

Weeks 1, 8-10, 16-20 and 6 months later
Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I)
時間枠:Weeks 1 and 16-20

This measure will be used to assess overall severity (CGI-S) and improvement (CGI-I) in adolescent ARFID. Total score range for each is 1-7. (Scores of 1 ("very much improved/normal") or 2 ("much improved/borderline ill") indicate a positive treatment response; all other responses are considered negative responses. Higher scores indicate worse outcome.

Weeks 1 and 16-20

二次結果の測定

結果測定
メジャーの説明
時間枠
Children's Food Neophobia Scale - six item version (CFNS-6)
時間枠:Weeks 1, 8-10, 16-20 and 6 months later

This measure of children's reluctance to try new or unfamiliar foods contains 6 items rated on a 4-point scale from 1 ("strongly disagree") to 4 ("strongly agree"), with 2 items reverse-scored. Total score range = 1 to 24, with higher scores indicating greater food neophobia.

Weeks 1, 8-10, 16-20 and 6 months later
Caregiver Strain Questionnaire (CGSQ)
時間枠:Weeks 1, 8-10, 16-20 and 6 months later

This scale will measure the strain caregivers experience as a result of their child's emotional and behavioral problems. It contains 21 items, each rated on a 5-point scale from 1 ("not at all a problem") to 5 ("very much a problem") for how much each occurrence or feeling was a problem in the past 6 months. The items form three subscales: objective strain (11 items), subjective internalized strain (6 items), and subjective externalized strain (4 items). Subscale and global scores are item means, 1 item ("relating well to child") is reverse scored. Scores range = 1 to 5, with higher scores indicating greater strain.

Weeks 1, 8-10, 16-20 and 6 months later
Parent-Rated Food Flexibility Scale (FFS)
時間枠:Weeks 1, 8-10, 16-20 and 6 months later

This scale is a 10-item parent-report measure of the child's tolerance of variability across food-related domains. Parents rate each domain on a 5-point scale from 0 ("very inflexible") to 4 ("very flexible"), with "mostly inflexible" (1), "some flexibility" (2), and "mostly flexible" (3) in between. Ratings are summed to a total score (range = 0 to 40), with higher scores indicating greater flexibility.

Weeks 1, 8-10, 16-20 and 6 months later
Acceptance and Confidence Scale - Anxiety
時間枠:Weeks 1, 8-10, 16-20 and 6 months later

This scale is a measure of the extent to which parents express acceptance of and confidence in the face of their child's anxiety, a key clinical target of SPACE. It contains 8 items, each rated on a 6-point scale from 1 ("strongly disagree") to 6 ("strongly agree"). Total score range = 8 to 48, with higher scores indicating greater acceptance and confidence.

Weeks 1, 8-10, 16-20 and 6 months later
Weekly Food Update
時間枠:Weeks 1-20

This brief questionnaire tracks changes in the child's eating over the course of treatment. Parents complete it before each weekly session, thinking back over the past week. The form has two parts. In the first, parents indicate whether their child ate each food already being tracked, and if so, how much (a taste, some, or a full portion), and whether the child now eats it regularly. In the second, parents record foods that are new that week: foods the child has never eaten before, foods the child is eating again after a long period of avoidance, and familiar foods eaten in a new way (for example, a different brand, preparation, or setting).

Weeks 1-20
Parent-completed Glasgow Sensory Questionnaire, short form (rGSQ-P)
時間枠:Weeks 1, 8-10, 16-20 and 6 months later

This scale has 24 items and measures children's sensory hyper- and hypo-sensitivity across six sense domains (visual, auditory, gustatory, olfactory, tactile, vestibular). Parents rate items on a 5-point scale from 0 ("never") to 4 ("always"), yielding total (0-96), hyper-sensitivity (0-48), and hypo-sensitivity (0-48) scores, with higher scores indicating greater sensory sensitivity.

Weeks 1, 8-10, 16-20 and 6 months later
Client Satisfaction Questionnaire (CSQ-8)
時間枠:Week 16-20

This 8-item measure assesses client satisfaction. Parents and adolescents rate items on a 0-4 scale, with higher summed scores indicating greater satisfaction with services (range = 0 to 32).

Week 16-20

その他の成果指標

結果測定
メジャーの説明
時間枠
Family Accommodation Scale - Anxiety (FASA-C/P)
時間枠:Weeks 1 and 16-20

This scale is a widely used measure of family accommodation. Adolescents and parents rate 9 items on a 5-point scale from 0 ("never") to 4 ("daily"). Total score range = 0 to 36.

Weeks 1 and 16-20
Family Assessment Device - General Functioning Scale (FAD-GF)
時間枠:Weeks 1 and 16-20

This scale measures overall family functioning. Adolescents and parents rate 12-items on a 4-point scale from 0 ("strongly disagree") to 3 ("strongly agree"). Total score range = 0 to 36.

Weeks 1 and 16-20

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

捜査官

  • 主任研究者:Eli Lebowitz、Yale University

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 (推定)

2026年12月1日

一次修了 (推定)

2030年12月1日

研究の完了 (推定)

2030年12月1日

試験登録日

最初に提出

2026年10月29日

QC基準を満たした最初の提出物

2026年10月29日

最初の投稿 (実際)

2026年11月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月4日

QC基準を満たした最後の更新が送信されました

2026年10月29日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2000044082

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いいえ

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