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L'essai clinique NCT07385469 (SOS OPC ARFID) pour ARFID est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Sensory Feeding and Parent Coaching for Children With ARFID (SOS OPC ARFID) 45 Randomisé Adolescent
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07385469 (SOS OPC ARFID) est une étude interventionnel pour ARFID. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 15 janvier 2026, avec un objectif de 45 participants. Dirigée par l'Université Hacettepe, l'étude devrait être terminée d'ici le 30 avril 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 4 février 2026.
Résumé succinct
This study aims to investigate the effects of the SOS approach alone, or the SOS approach plus the OPC intervention, on children's feeding problems and feeding behaviors, as well as parents' feeding attitudes and mealtime behaviors in children diagnosed with ARFID. This randomized, single-blind, controlled trial will be conducted with children aged 3-8 years who were diagnosed with ARFID by a Child and Adolescent Psy...Afficher plus
Description détaillée
Avoidant/Restrictive Food Intake Disorder (ARFID), defined and included in the diagnostic categories with the publication of the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) by the American Psychiatric Association, is a serious disorder related to feeding behavior. According to DSM-5, ARFID is characterized by one or more of the following criteria: significant weight loss (or failure ...Afficher plus
Titre officiel
Effects of the Sequential Oral Sensory Feeding Approach and Occupational Performance Coaching in Children With Avoidant/Restrictive Food Intake Disorder (ARFID): A Randomized Controlled Trial
Pathologies
ARFIDPublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- SOS OPC ARFID
- SBF 25/092
Numéro NCT
Date de début (réel)
2026-01-15
Dernière mise à jour publiée
2026-02-04
Date de fin (estimée)
2026-04-30
Inscription (estimée)
45
Type d'étude
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
ARFID
Eating Disorder
Occupational Therapy
Sensory Feeding
Occupational Performance Coaching
Eating Disorder
Occupational Therapy
Sensory Feeding
Occupational Performance Coaching
Objectif principal
Soins de soutien
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifThe group that applied only the SOS approach for 60 minutes, once a week for 12 weeks Children in the first group will receive the intervention once a week for 60 minutes over a period of 12 weeks. The SOS approach is used as a structured intervention that supports sensory-motor skills related to feeding and aims to help the child develop a positive relationship with food. By gradually increasing interaction with food, the SOS approach aims to reduce sensory sensitivities and improve feeding behaviors...Afficher plus | Sequential Oral Sensory (SOS) Feeding Approach The SOS Feeding Approach is a structured, evidence-informed intervention that gradually exposes children with ARFID to food across multiple sensory dimensions, recognizing that these children often experience heightened sensitivities to textures, smells, and tastes that can trigger avoidance and distress. Unlike traditional behavioral methods that focus primarily on intake, SOS emphasizes building comfort, positive a...Afficher plus |
Comparateur actifThe group that received 60 minutes of SOS + 30 minutes of OPC once a week for 12 weeks Children in the second group will receive the SOS approach combined with the Occupational Performance Coaching (OPC) program. After completing the 60-minute SOS session, 30-minute OPC sessions will also be delivered once a week for 12 weeks on an individual basis.
OPC enables parents to set goals, develop strategies, and evaluate progress aimed at improving their child's daily life performance.
Sessions are conduct...Afficher plus | SOS + Occupational Performance Coaching (OPC) In the combined SOS and OPC intervention, children receive a 60-minute SOS session each week for 12 weeks, immediately followed by a 30-minute OPC session with their parents. SOS targets the child's sensory tolerance and positive engagement with food, while OPC uses a semi-structured coaching format where parents set meaningful feeding goals, analyze mealtime routines, and develop sustainable strategies with the ther...Afficher plus |
Aucune interventionControl Group (Waitlist) Participants assigned to the control group will be placed on a waiting list and will not receive any intervention during the 12-week study period. They will complete baseline and post-test assessments at the same time points as the intervention groups, allowing for comparison of outcomes. After the study is completed, families in this group will be offered the effective intervention program outside of the research pr...Afficher plus | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Behavioral Pediatric Feeding Scale | The Behavioral Pediatric Feeding Assessment Scale (BPFAS), was adapted into Turkish , and later studied with parents of children aged 3-12 years attending preschool and primary school. The original scale consists of 35 items, 25 of which relate to the child's feeding behavior and 10 to the caregiver responsible for feeding. However, the Turkish adaptation was conducted using only the 25 items related to the child. Among these, six items are positively worded (items 1, 3, 5, 6, 9, and 16), while the remaining 19 are negatively worded. Responses are scored on a five-point Likert scale ranging from 1 (never) to 5 (always), with positively worded items reverse-scored. Parents are asked whether each item represents a problem for them. A total score above 84 indicates the presence of a feeding disorder, while reporting more than nine problematic items reflects a high number of feeding-r | 12 weeks |
Children's Eating Behavior Questionnaire | The Children's Eating Behaviour Questionnaire (CEBQ), is a parent-reported, Likert-type questionnaire designed to assess eating behaviors in children aged 2-9 years. It includes 35 items rated on a 5-point scale (1 = never, 5 = always) and encompasses eight subscales that reflect different aspects of children's eating behaviors. Reported Cronbach's alpha coefficients for the original scale range from 0.72 to 0.91, indicating good internal consistency. The validity and reliability of the CEBQ in Turkey were examined.The scale consists of eight subscales that can be grouped into two main dimensions. | 12 weeks |
Sensory Eating Problems Scale | The Sensory Eating Problems Scale (SEPS) was developed for children aged 3-11 years to evaluate sensory-related feeding difficulties. The scale consists of 22 items rated on a 5-point Likert scale (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always) and includes six subscales: Food Texture Aversion, Single Food Focus, Vomiting, Temperature Sensitivity, Expulsion, and Overstuffing. SEPS is completed by the child's caregiver. Confirmatory factor analysis by Seiverling et al. (2019) reported χ²/df = 2.63, CFI = 0.90, and RMSEA = 0.06, supporting the six-factor model as an acceptable structure for assessing sensory feeding problems. In addition, Cronbach's alpha values for the subscales were 0.85 for Food Texture Aversion, 0.70 for Single Food Focus, 0.73 for Vomiting, 0.72 for Temperature Sensitivity, 0.71 for Expulsion, and 0.71 for Overstuffing. The Turkish validity and reliability study was conducted by Demirok et al. in children aged 3-11 years. | 12 weeks |
Sensory Profile | The Sensory Profile, developed by Dunn and colleagues, is used to assess sensory processing abilities in children aged 3-10 years. It consists of 125 items and evaluates three main domains: Sensory Processing (6 subdomains), Sensory Modulation (5 subdomains), and Behavioral and Emotional Responses (3 subdomains). The subdomains include Auditory Processing, Visual Processing, Vestibular Processing, Tactile Processing, Multisensory Processing, Oral Sensory Processing, Sensory Processing related to Endurance and Tone, Regulation of Movement and Body Position, Regulation of Activity Level by Movement, Modulation of Sensory Input Affecting Emotional Responses, Modulation of Visual Input Affecting Emotional Responses and Activity Level, Emotional/Social Responses, Behavioral Outcomes of Sensory Processing, and Items Indicating Thresholds of Responsiveness. The Turkish validity and reliability study of the scale was conducted by Kayıhan and colleagues. | 12 weeks |
Goal Attainment Scale (GAS) | The Goal Attainment Scaling (GAS) is widely used in patient-centered treatment approaches with no age restrictions, and it is based on the principle of collaboratively setting treatment goals between the therapist and the patient. In this study, parents are asked during the initial assessment to define five individual goals they wish to achieve throughout the therapy process. Each goal is prioritized by the parent, who also rates the perceived level of difficulty. At the post-treatment evaluation, each goal is scored on a five-point scale ranging from -2 to +2 (-2 = much less than expected outcome, -1 = somewhat less than expected, 0 = expected outcome, +1 = somewhat more than expected, +2 = much more than expected). As a performance-based measure, GAS does not require separate validity and reliability testing for the Turkish context. | 12 weeks |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Parental Feeding Style Questionnaire | The Parent's Feeding Style Questionnaire (PFSQ), developed by Wardle et al. (2002), was adapted into Turkish by Özçetin et al. (2010) in a study including 468 parents of children aged 2-9 years. In the original version, the four-factor structure showed Cronbach's alpha values ranging from 0.67 to 0.85. In the Turkish validity and reliability study, a five-factor structure was identified, where the original "control over eating" factor was divided into "strict control feeding" and "permissive control feeding." Cronbach's alpha coefficients for the Turkish version ranged from 0.54 to 0.83 across the factors. | 12 weeks |
Maternal Attitudes towards the Feeding Process Scale | The mother's attitude during the feeding process was assessed using the Feeding Process Maternal Attitude Scale. The validity of this scale was tested in mothers over the age of 18. It consists of 27 items and five subscales. In this study, the internal consistency coefficient was found to be Cronbach's α = 0.88. The scale is rated on a five-point Likert system (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Always), with a minimum possible score of 27 and a maximum of 135. The subscales are: negative emotional state during meals, attitudes toward inadequate/unbalanced nutrition, negative feeding strategies, force-feeding, and reaction to others' opinions. Higher scores indicate an increase in problematic maternal attitudes related to the feeding process. Since the scale has no cut-off score, results were ranked from lowest to highest and divided into quartiles for evaluation. | 12 weeks |
Parenting Stress Index-Short Form | The Parenting Stress Index (PSI) was developed by Abidin (1982) to assess the level of stress experienced by parents of children with developmental disorders. The short form of the PSI (PSI-SF) was adapted into Turkish for parents of children aged 6 months to 14 years. The PSI-SF consists of 36 items across three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. In addition to subscale scores, a total stress score can also be calculated. Reported internal consistency (Cronbach's alpha) coefficients were 0.71 for the total stress score, 0.81 for the Parental Distress subscale (items 1-12), 0.76 for the Parent-Child Dysfunctional Interaction subscale (items 13-24), and 0.78 for the Difficult Child subscale (items 25-36). Test-retest reliability was reported as r = 0.88. Researchers have concluded that the scale is a suitable tool for measuring parenting stress and demonstrates cross-cultural validity. | 12 weeks |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Enfant
Âge minimum
3 Years
Sexes éligibles
Tous
Inclusion Criteria (for the child):
- Having been diagnosed with ARFID according to the DSM-5 by a Child and Adolescent Mental Health and Diseases psychiatrist (Assoc. Prof. Dr. Hakan ÖĞÜTLÜ).
- Being between the ages of 3 and 8.
- Being medically stable for outpatient treatment.
- Having no conditions (visual, auditory, cognitive, or chewing) that would prevent participation in treatment.
Inclusion Criteria (for the mother):
- Being the child's primary caregiver and living with the mother.
- Having at least a primary school diploma and possessing Turkish reading and comprehension proficiency.
- Agreeing to take an active role in the intervention process and participate in research evaluations.
- Being a regular participant in the child's feeding process.
- Not having another child with special needs.
Exclusion Criteria (Child):
- History of comorbid neurological, genetic, psychiatric, or metabolic disease
- Child and family receiving other individual or family-based education and/or psychotherapy during the intervention
- Taking medication for comorbid disorders affecting appetite and/or weight
- Active psychiatric crisis (e.g., severe anxiety disorder, post-traumatic stress disorder)
- Significant family or environmental constraints that would prevent regular attendance
Exclusion Criteria (Mother):
- Severe hearing, vision, or cognitive impairment
- Child concurrent participation in another intervention program (dietician, psychotherapy, group education, etc.) related to feeding behaviors
- Presence of a chronic health condition (e.g., neurological, psychiatric, orthopedic, oncological, etc.) that would prevent regular attendance at the intervention
Partie responsable de l'étude
Ezginur Gündoğmuş, Investigateur principal, Research assisstant, Hacettepe University
Contact central de l'étude
Contact: Ezginur Gündoğmuş, MSc, +90 538 485 83 92, [email protected]
Contact: Gonca Bumin, Prof. Dr., 0 532 556 39 83, [email protected]
1 Centres de l'étude dans 1 pays
Altındağ
Hacettepe University, Department of Occupational Therapy, Pediatric Unit, Ankara, Altındağ, Turkey (Türkiye)
Ezginur Gündoğmuş, Contact, 05384858392, [email protected]