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治験 NCT05741840 (FRESH-A)（対象：自閉症スペクトラム障害、小児肥満、自閉症）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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カリフォルニア大学サンディエゴ校Family, Responsibility, Education, Support, and Health for Families With a Child With Autism (FRESH-A)
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05741840 (FRESH-A) は 介入研究 臨床試験 で、自閉症スペクトラム障害、小児肥満、自閉症 に関するものです。現在は 募集中 で、2023年8月18日 から開始しています。150 名の参加者 の募集が計画されています。この治験は カリフォルニア大学サンディエゴ校 によって主催され、2028年3月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月5日 です。
概要
The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE).
詳細説明
The study will compare the efficacy of PBT-A and health education program delivered via telehealth to parents on child weight management. Investigators will provide 6 months of a group program (PBT-A or HE) and will follow participants for 12-months post-treatment (total time = 18 months). Investigators will recruit parents of children diagnosed with autism and overweight or obesity. Assessments will occur at 5 timepoints: baseline, mid-treatment, post-treatment, 6-month and 12-month follow-up. Assessments will include anthropometry for both parent and child. Parent will also provide information regarding autism diagnosis and characteristics, eating behaviors, and parenting relationship measures. This program of research has the potential to advance the standard of practice for children with autism and overweight or obesity by developing tailored interventions which can be easily disseminated.
公式タイトル
Telehealth Parent-only Treatment for Youth With Autism Spectrum Disorder and Overweight/Obesity
疾患／病気
自閉症スペクトラム障害小児肥満自閉症その他の研究識別子
- FRESH-A
- 802230
- R01HD106991 (米国NIHの助成金/契約)
NCT番号
開始日
2023-08-18
最終更新日
2025-09-05
終了予定日
2028-03-31
目標参加者数
150
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
obesity
treatment
intervention
Autism
behavioral treatment
parent based treatment
children
treatment
intervention
Autism
behavioral treatment
parent based treatment
children
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的PBT-A PBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth. | PBT-A PBT-A provides all the elements of family based treatment for children with obesity, including nutrition and physical activity education, behavior therapy skills, and parenting skills. |
実薬対照薬Health Education This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth. | 健康教育 (HE) The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Child BMIz age and sex adjusted BMI (kg/m^2) | age and sex adjusted body mass index (BMI) z-score based on the CDC norms | Change from baseline to month 3, 6, 12, and 18 |
Child %BMIp95 | Age and Sex specific percentage of the 95th percentile BMI for age and sex that is more sensitive to change in children with higher weights | Change from baseline to month 3, 6, 12, and 18 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Parent Dietary Intake | Block Fat/Sugar/Fruit/Vegetable Screener for adults | Change from baseline to month 6, 12, and 18 |
Child Dietary Intake | BLOCK kids food screener completed by parent | Change from baseline to month 6, 12, and 18 |
Parent Physical Activity | The International Physical Activity Questionnaire (IPAQ) | Change from baseline to month 6, 12, and 18 |
Child Physical Activity | The Children's Physical Activity Questionnaire (C-PAQ) parent proxy | Change from baseline to month 6, 12, and 18 |
Child Mealtime Behaviors | The Brief Autism Mealtime Behavior Inventory (BAMBI) with scores ranging from 18 to 90 with higher scores indicating greater mealtime problem behaviors | Change from baseline to month 6, 12, and 18 |
Parent self-efficacy | The Parenting Sense of Competence Scale (PSOC) - Scores range from 17-102 with higher scores representing higher parenting sense of competence. | Change from baseline to month 6, 12, and 18 |
Parent body mass index (BMI) | kg/m\^2 | Change from baseline to mid-treatment, months: 3, 6, 12, and 18 |
Parenting as measured by the Alabama Parenting Questionnaire (APQ) | Parents will self-report parenting behaviors via the APQ across 5 domains: 1) positive involvement with children, 2) supervision and monitoring, 3) use of positive discipline techniques, 4) consistency in the use of such discipline, and 5) use of corporal punishment. Higher scores indicate greater frequency of engagement with that particular parenting domain. Scores range from 1-5. | Change from baseline to month 6, 12, and 18 |
適格基準
対象年齢
小児
試験の最低年齢
6 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- A child with OW/OB (>=85% BMI for age) aged 6-12 years
- Documented (1) community diagnosis or provisional diagnosis of ASD or (2) educational diagnosis of ASD
- The child meets cut-off criteria for autism on the Autism Diagnostic Interview-Revised (ADI-R), as well as overall DSM 5 criteria based on the clinical judgement of an experienced clinician
- The parent who is responsible for food preparation is willing to participate
- The family is willing to commit to attending all treatment and assessment sessions
- Child on a stable medication regimen (minimum of 3 months)
- Child does not have any medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity or at least facilitate support of child's completion of recommended physical activity.
- Child and/or parent are not participating in another organized weight control program
- Family owns a device that can facilitate zoom meetings
- Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and/or exercise is needed
- Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report
- Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, moderate or severe alcohol or substance use disorder) that could interfere with treatment.
- Parent is not currently pregnant, lactating or planning to get pregnant during the study duration
- Parent has had bariatric surgery less than 6 months ago and/or is not yet eating solid food or is planning to have bariatric surgery over the study duration
- Child is taking medication for the purpose of weight loss
カリフォルニア大学サンディエゴ校339 件のアクティブな治験を探索Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)責任者
Kerri Boutelle, 研究責任者, Kerri Boutelle, Professor of Pediatrics, Psychiatry, and Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego
試験中央連絡先
連絡先: Recruitment Coordinator, 8558273498, [email protected]
連絡先: Kerri Boutelle, Ph.D., 858249-3528, [email protected]
1 1カ国の場所
California
UC San Diego Center for Healthy Eating and Activity Research (CHEAR), La Jolla, California, 92037, United States
Kerri Boutelle, Ph.D., 連絡先, 8582493528, [email protected]
募集中