NCT07385469

Brief Summary

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 Psychiatrist according to DSM-V criteria and referred to an occupational therapy department. Power analysis determined the sample size to be 45 children (15 per group). Participants will be assigned to three groups using computer-assisted block randomization: Group 1: Sequential Oral Sensory (SOS) Feeding Approach alone; Group 2: SOS approach plus Occupational Performance Coaching (OPC); and Group 3: Control group (standard follow-up without intervention). The study design will utilize the Consort checklist used for randomized controlled trials. Informed consent will be obtained from participants. Pre- and post-intervention assessments will be conducted on the child's feeding behaviors, food variety, and mealtime negative behaviors, as well as parental feeding attitudes, mealtime behaviors, and stress. The study concludes that feeding interventions implemented using the SOS approach will be effective in reducing food acceptance, food variety, and mealtime negative behaviors in children with ARFID. These effects are expected to be more pronounced and sustained when Occupational Performance Coaching (OPC) is added to the SOS approach. Furthermore, positive changes in parents' feeding attitudes and strengthened parent-child interactions at mealtime are anticipated. These results will contribute to the literature on the effectiveness of using sensory-based approaches and family-based counseling in combination in interventions for ARFID. They are also expected to provide an evidence-based roadmap for occupational therapists to develop holistic intervention programs when working with children with ARFID in clinical practice.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

September 5, 2025

Last Update Submit

January 29, 2026

Conditions

Keywords

ARFIDEating DisorderOccupational TherapySensory FeedingOccupational Performance Coaching

Outcome Measures

Primary Outcomes (5)

  • 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

Secondary Outcomes (3)

  • Parental Feeding Style Questionnaire

    12 weeks

  • Maternal Attitudes towards the Feeding Process Scale

    12 weeks

  • Parenting Stress Index-Short Form

    12 weeks

Study Arms (3)

The group that applied only the SOS approach for 60 minutes, once a week for 12 weeks

ACTIVE COMPARATOR

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. The intervention is structured to increase the child's tolerance to food through the following sequence: Visual Tolerance The child only looks at the food without physical contact. The food remains on the table, maintaining distance from the child. Phrases such as "we can just look at this" or "we can recognize it with our eyes" are used. Bringing Food Closer / Smelling The food is brought into the child's personal space. To build tolerance to smell, the food is held close to the nose. This stage is particularly important for children with olfactory sensitivities

Behavioral: Sequential Oral Sensory (SOS) Feeding Approach

The group that received 60 minutes of SOS + 30 minutes of OPC once a week for 12 weeks

ACTIVE COMPARATOR

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 conducted in a semi-structured interview format with the therapist. Focus areas include: establishing feeding routines, parent-child interaction, home-based implementation strategies, and parental self-efficacy. OPC is a family-centered, occupation-based, coaching approach implemented by occupational therapists in collaboration with families to enhance children's participation in daily life. The aim is to guide parents in making environmental adjustments that support their children's functional goals and to empower them to generate their own solutions. Phases of OPC: Goal Set

Behavioral: SOS + Occupational Performance Coaching (OPC)

Control Group (Waitlist)

NO INTERVENTION

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 protocol to ensure ethical access to treatment.

Interventions

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 associations, and sensory tolerance before progressing to consumption. Delivered in 12 weekly 60-minute sessions by trained occupational therapists, the approach is individualized to each child's developmental stage, medical history, and swallowing safety, with foods selected accordingly. Sessions progress through a hierarchy-visual tolerance, olfactory exposure, tactile exploration, oral contact, intraoral exploration, and finally chewing and swallowing-ensuring gradual, non-coercive acceptance. By integrating sensory-motor learning with feeding, the intervention reduces m

The group that applied only the SOS approach for 60 minutes, once a week for 12 weeks

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 therapist. Parents implement these strategies at home and review progress in subsequent sessions, ensuring continuous feedback and adjustment. This dual approach is distinguished by its family-centered nature, empowering parents as active agents of change, and by its integration of child-focused sensory therapy with parent coaching to reinforce improvements across home and clinical settings. By addressing both sensory challenges and parent-child dynamics, the intervention aims to reduce mealtime anxiety, expand food acceptance, strengthen parental self-efficacy, and achieve mor

The group that received 60 minutes of SOS + 30 minutes of OPC once a week for 12 weeks

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Department of Occupational Therapy, Pediatric Unit

Ankara, Altındağ, Turkey (Türkiye)

Location

Related Publications (6)

  • Chilman LB, Meredith PJ, Southon N, Kennedy-Behr A, Frakking T, Swanepoel L, Verdonck M. Occupational Performance Coaching for parents of picky eaters: A mixed methods study. Aust Occup Ther J. 2024 Oct;71(5):644-660. doi: 10.1111/1440-1630.12947. Epub 2024 Mar 27.

    PMID: 38538542BACKGROUND
  • Angelin CS, Sugi S, Rajendran K. Occupational Performance Coaching for Mothers of Children with Disabilities in India. Can J Occup Ther. 2021 Mar;88(1):38-47. doi: 10.1177/0008417420972868. Epub 2020 Dec 23.

    PMID: 33353385BACKGROUND
  • Graham F. Occupational performance coaching: Client-centered and goal-directed practice; A commentary on collaborations with Sylvia Rodger. Aust Occup Ther J. 2017 Jul;64 Suppl 1:31-32. doi: 10.1111/1440-1630.12367. No abstract available.

    PMID: 28714162BACKGROUND
  • Schoen SA, Balderrama R, Dopheide E, Harris A, Hoffman L, Sasse S. Methodological Components for Evaluating Intervention Effectiveness of SOS Feeding Approach: A Feasibility Study. Children (Basel). 2025 Mar 17;12(3):373. doi: 10.3390/children12030373.

  • Chilman LB, Meredith PJ, Kennedy-Behr A, Campbell G, Frakking T, Swanepoel L, Verdonck M. Picky eating in children: Current clinical trends, practices, and observations within the Australian health-care context. Aust Occup Ther J. 2023 Aug;70(4):471-486. doi: 10.1111/1440-1630.12869. Epub 2023 May 1.

  • Peterson KM, Piazza CC, Volkert VM. A comparison of a modified sequential oral sensory approach to an applied behavior-analytic approach in the treatment of food selectivity in children with autism spectrum disorder. J Appl Behav Anal. 2016 Sep;49(3):485-511. doi: 10.1002/jaba.332. Epub 2016 Jul 23.

Related Links

MeSH Terms

Conditions

Avoidant Restrictive Food Intake DisorderFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ezginur Gündoğmuş, MSc

CONTACT

Gonca Bumin, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The single-blind method in this study is based on the principle that the experts conducting the evaluations are unaware of the group assignment; thus, the measurement results will be evaluated independently of the intervention information. While the intervention implementers have knowledge of the groups, analysts during the data analysis phase will be blinded to the groups.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This randomized, single-blind, controlled study will be conducted with children aged 3-8 years who were diagnosed with ARFID by a Child and Adolescent Psychiatrist according to DSM-V criteria and referred to the occupational therapy department. Based on the power analysis using effect size (f = 0.35), α = 0.05, and power (1-β) = 0.80, a total of 39 children were required, with at least 13 participants in each group. With a 15% probability of missing data estimate, the total sample size was determined to be 45 children. The Consort checklist used for randomized controlled trials will be used in the study design. The single-blind method in the study is based on the principle that the experts conducting the evaluations are unaware of the group assignment; thus, the measurement results will be evaluated independently of any knowledge of the intervention. While the intervention providers have knowledge of the groups, the analysts will work blindly during the data analysis phase. Informed co
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assisstant

Study Record Dates

First Submitted

September 5, 2025

First Posted

February 4, 2026

Study Start

January 15, 2026

Primary Completion

March 30, 2026

Study Completion

April 30, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

We plan to share individual participant data (IPD) that underlie the results reported in published articles, including de-identified demographic characteristics, baseline assessments, outcome measures, and intervention-related data. All shared IPD will be fully anonymized to ensure participant confidentiality.

Shared Documents
SAP, CSR
Time Frame
Individual participant data (IPD) and supporting documents will be available starting 6 months after publication of the primary study results and will remain accessible for 5 years thereafter.
Access Criteria
De-identified individual participant data (IPD) and supporting documents will be available to qualified researchers from academic institutions, hospitals, or recognized research organizations. Data will be shared only for projects with a sound scientific rationale and an established analysis plan. Researchers must submit a formal request describing study aims, methodology, and data protection procedures. Access will be granted through a secure, password-protected platform managed by the sponsor. Approved researchers will be required to sign a data use agreement to ensure confidentiality, proper use of the data, and compliance with ethical and legal standards.
More information

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