Trials / Not Yet Recruiting
Not Yet RecruitingNCT07385469
Sensory Feeding and Parent Coaching for Children With ARFID
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Hacettepe University · Academic / Other
- Sex
- All
- Age
- 3 Years – 8 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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 to achieve expected weight gain/growth in children), marked nutritional deficiencies, dependence on enteral feeding or oral nutritional supplements, and/or marked impairment in psychosocial functioning. This condition differs from culturally normative fasting or attempts to lose weight and is not associated with a fear of body shape or weight. In children with ARFID, food selectivity, insufficient food intake, and intense negative emotions related to feeding are observed. This disorder not only leads to weight loss and growth retardation but also significantly affects children's daily life activities, family life, and social interactions. ARFID has a prevalence rate of 3.2% in the general pediatric population. It has been reported that the proportion of males is higher in ARFID diagnoses and that, compared to other DSM-5 eating disorders, it is more frequently associated with comorbid psychiatric and/or medical conditions. However, ARFID is a heterogeneous condition that includes individuals ranging from young children to adults. Prevalence estimates for ARFID vary widely depending on the population and setting examined. A systematic review found that in non-clinical child and adolescent samples, estimated prevalence rates for ARFID ranged between 0.3% and 15.5%. The prevalence has been reported as 64% among infants and young children, and 15.5% among children aged 5-10 years. To date, most research on ARFID treatment has focused on psychological interventions, which typically include psychoeducation, exposure, and cognitive-behavioral therapy, family-based treatment, or applied behavior analysis approaches. Occupational therapists assess and address feeding difficulties by considering sensory differences, physical and cognitive impairments, as well as broader contextual factors such as social environments, mealtime rituals and routines, culture, and social factors. It has been emphasized that occupational therapy interventions are needed for individuals with ARFID. Occupational therapists have demonstrated effectiveness using approaches such as the Sequential Oral Sensory (SOS) Feeding Approach, Sensory Integration, the Just Right Challenge Feeding Protocol, and family-based programs such as Occupational Performance Coaching (OPC). Studies highlight the need to standardize occupational therapy approaches for ARFID and to conduct single-case experimental designs and randomized controlled trials comparing these approaches with alternative methods. In this context, the Sequential Oral Sensory (SOS) Feeding Approach is 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. It has been shown to be effective particularly in children with autism spectrum disorder and in other diagnostic groups with feeding difficulties. However, no randomized controlled trial has yet been found addressing the use of this approach in children with ARFID. On the other hand, Occupational Performance Coaching (OPC) is a structured, problem-solving, guidance, and empowerment-based approach designed to help parents support their children's daily life performance. Studies conducted with families of children with developmental differences have shown that OPC contributes positively to parental self-efficacy, stress levels, and children's participation levels. While studies have demonstrated its effectiveness in children with selective eating problems, it has been emphasized that its effectiveness should be further tested in randomized controlled trials. Despite existing psychosocial interventions for ARFID, the literature highlights a lack of sensory- and behaviorally-oriented feeding interventions. Therefore, this randomized controlled single-blind study aims to examine the effects of the SOS approach alone and in combination with OPC on feeding problems and feeding behaviors of children with ARFID, as well as on parental feeding attitudes and mealtime behaviors. By going beyond child-focused sensory-based interventions, this study also evaluates the effectiveness of family-centered approaches. The study aims to make an original contribution to the development of applicable and effective intervention models for children and families dealing with ARFID, both at the clinical and societal levels.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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 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 |
| BEHAVIORAL | 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 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 |
Timeline
- Start date
- 2026-01-15
- Primary completion
- 2026-03-30
- Completion
- 2026-04-30
- First posted
- 2026-02-04
- Last updated
- 2026-02-04
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07385469. Inclusion in this directory is not an endorsement.