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Technology-supported Behavioral Feeding Intervention

2015年3月16日 更新者:William Sharp, PhD、Emory University

Development of a Manual-based, Technology-supported, Behavioral Feeding Intervention

This investigation proposes to examine the effectiveness of a technology supported treatment manual for pediatric feeding disorders. Children with pediatric feeding disorders display intense avoidance behaviors (e.g., crying, tantrums, and disruptions) that prevent appropriate nutritional intake during meals and lead to a number of negative and potentially life threatening medical outcomes, including chronic malnutrition, growth retardation, and placement of a feeding tube. To date, behavioral intervention involving extinction-based procedures represents the only treatment for pediatric feeding disorders supported by research to improve mealtime behaviors. Due to the chronic and extreme nature of food refusal, treatment typically requires intensive, daily intervention conducted at highly specialized clinics to improve feeding behaviors. The cost and duration of intervention can total as much as $60,000 per child requiring up to 6 to 8 weeks, respectively. The potential for serious consequences associated with chronic food refusal, combined with the high cost of treatment, intensifies the need to identify means to disseminate effective treatment approaches to the broader community of healthcare providers.

The proposed study represents the first attempt to systematically investigate the use of a treatment manual to address chronic food aversion through a randomized, waitlist control trial in children treated at the Marcus Autism Center's Pediatrics Feeding Disorders Program. This study will involve a total of 20 participants randomly assigned to experimental conditions: technology supported treatment manual or waitlist control group (10 in each group). Children assigned to the waitlist control group will receive the technology supported treatment manual after the specified time on the waitlist. All participants will receive the same behavioral protocol involving three treatment sessions per day (45 minutes in length), for a total of 15 sessions across five consecutive days. Data will be collected on feeding behaviors during each treatment session and at follow-up using trained observers to collect data on mealtime behaviors, including acceptance, swallowing, disruption, expulsion, and grams consumed. This type of data collection and treatment is standard practice in the feeding disorders program; however, the use of a touch screen application for data capture with integrated manual is novel to this project.

調査の概要

研究の種類

介入

入学 (実際)

20

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

    • Georgia
      • Atlanta、Georgia、アメリカ、30329
        • The Marcus Autism Center

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

1年~6年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

Participants must demonstrate failure to meet appropriate nutritional and/or energy needs based on DSM-V criteria (American Psychiatric Association, 2013) for Avoidant/Restrictive Food Intake Disorder, focusing exclusively on children with dependence on enteral feeding or oral supplementation with a nutritionally complete formula. Specifically, participants must have a history of food refusal as evidenced by tube, formula, or bottle dependence, receiving at least 50% of their nutritional needs from this method of intake. In order to be considered eligible, participants will need to meet the following inclusion criteria: 1) Present with partial food refusal as evidenced by greater than 50% of caloric needs met by bottle, formula, or tube feedings; 2) Have a medical history significant for an organic factor (e.g., gastrointestinal issues) which precipitated or played a role in the development of feeding concern; 3) Fall between the ages of 12 months and 6 years, which will ensure a sample of children appropriate for the introduction of solid food; and 4) Patients must be English literate.

Exclusion Criteria:

The following will be considered ineligible to participate in the study: 1) Patients with active medical diagnoses requiring hospitalization or significant oversight from a physician; and 2) Patients with active medical, structural, or functional limitations preventing safe oral intake of pureed foods (e.g., aspiration, upper airway obstruction).

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:Technology Supported Manual
Participants in this arm will receive behavioral intervention for a period of 5 consecutive days. A total of 3, 45-minute meals will be held at regularly scheduled times (e.g., 9:00 a.m., 10:30 a.m., and 12:00 p.m.) each day for a total of 15 meals throughout treatment.
介入なし:Waitlist
Participants will serve as the control condition.

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
Mealtime Behaviors
時間枠:1 week
Behavioral ratings will document such variables as acceptance, mouth clean, combined inappropriate behavior, expulsions, and grams consumed. Data on each of these variables will be collected on computers using an event-recording program built into the computerized manual. Acceptance will be scored when a child takes one or more bites independently every 30 seconds or allows the entire bite of food to be deposited in his/her mouth within 5 seconds of the initial presentation. A mouth clean will be scored when the child swallows all the food within 30 seconds. Data will also be collected on combined inappropriate mealtime behaviors, which are defined as head turns and disruptions. Expulsions will be defined as the presence of food greater than the size of a pea visible outside the mouth after the bite enters the child's mouth.
1 week

二次結果の測定

結果測定
メジャーの説明
時間枠
Parenting Stress Index- Short Form
時間枠:1 month
The PSI-SF is a screening instrument designed to provide an indication of the overall level of parenting stress an individual is experiencing through self-report. It is comprised of three subscales of 12 items each: Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC). It has been used in pediatric samples and has exhibited high internal reliability.
1 month

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

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

2014年1月1日

一次修了 (実際)

2014年12月1日

研究の完了 (実際)

2015年3月1日

試験登録日

最初に提出

2014年3月24日

QC基準を満たした最初の提出物

2014年4月18日

最初の投稿 (見積もり)

2014年4月22日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年3月17日

QC基準を満たした最後の更新が送信されました

2015年3月16日

最終確認日

2015年3月1日

詳しくは

本研究に関する用語

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。

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