[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622580":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":47,"locations":57,"responsibleParty":73,"collaborators":35,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":35,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":101,"whyStopped":35,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Hacettepe University","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"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:\n\nVisual Tolerance\n\nThe child only looks at the food without physical contact.\n\nThe food remains on the table, maintaining distance from the child.\n\nPhrases such as \"we can just look at this\" or \"we can recognize it with our eyes\" are used.\n\nBringing Food Closer \u002F Smelling\n\nThe food is brought into the child's personal space.\n\nTo build tolerance to smell, the food is held close to the nose.\n\nThis stage is particularly important for children with olfactory sensitivities",[13],"Behavioral: Sequential Oral Sensory (SOS) Feeding Approach",{"label":15,"type":10,"description":16,"interventionNames":17},"The group that received 30 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.\n\nOPC enables parents to set goals, develop strategies, and evaluate progress aimed at improving their child's daily life performance.\n\nSessions are conducted in a semi-structured interview format with the therapist.\n\nFocus areas include: establishing feeding routines, parent-child interaction, home-based implementation strategies, and parental self-efficacy.\n\nOPC 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.\n\nPhases of OPC:\n\nGoal Set",[18],"Behavioral: SOS + Occupational Performance Coaching (OPC)",{"label":20,"type":10,"description":21,"interventionNames":22},"Control 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 protocol to ensure ethical access to treatment.",[23],"Behavioral: Waitlist",{"label":25,"type":10,"description":26,"interventionNames":27},"OPC Group","Occupational Performance Coaching (OPC) is a evidence-based, family-centered coaching intervention developed by Dr. Fiona Graham (University of Otago, NZ). OPC enables parents to identify meaningful participation goals, analyze performance barriers, and develop their own strategies to support their child's daily functioning.\n\nOPC is structured around three enabling domains: Connect (building a trusting therapeutic partnership), Structure (collaborative performance analysis and goal-directed action), and Share (facilitating reflection and knowledge exchange). Sessions are delivered in a semi-structured interview format by an occupational therapist.\n\nIn this study, OPC will be delivered once weekly for 12 weeks (30-minute individual sessions). Focus areas include feeding routines, parent-child mealtime interaction, home-based implementation strategies, and parental self-efficacy. The primary outcome will be measured using the Goal Assessment Scale",[28],"Behavioral: OPC Group",[30,36,40,43],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"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",[9],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"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",[15],{"type":31,"name":25,"description":41,"armGroupLabels":42,"otherNames":35},"Occupational Performance Coaching (OPC) is a evidence-based, family-centered coaching intervention developed by Dr. Fiona Graham (University of Otago, NZ). OPC enables parents to identify meaningful participation goals, analyze performance barriers, and develop their own strategies to support their child's daily functioning.\n\nOPC is structured around three enabling domains: Connect (building a trusting therapeutic partnership), Structure (collaborative performance analysis and goal-directed action), and Share (facilitating reflection and knowledge exchange). Sessions are delivered in a semi-structured interview format by an occupational therapist.\n\nIn this study, OPC will be delivered once weekly for 12 weeks (30-minute individual sessions). Focus areas include feeding routines, parent-child mealtime interaction, home-based implementation strategies, and parental self-efficacy. The primary outcome will be measured using the Goal Assessment Scale (GAS)",[25],{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":35},"Waitlist","The 15 children on the waiting list will be selected as a control group. These children will undergo an initial assessment, and no intervention will be applied for 12 weeks. Final test measurements will be taken at the end of the 12 weeks. After the study is completed, the effective intervention method will be applied to these children in the same manner, completely independent of the study.",[20],[48,53],{"name":49,"role":50,"phone":51,"phoneExt":35,"email":52},"Ezginur Gündoğmuş, MSc","CONTACT","+90 538 485 83 92","ezginurgundogmus06@gmail.com",{"name":54,"role":50,"phone":55,"phoneExt":35,"email":56},"Gonca Bumin, Prof. Dr.","0 532 556 39 83","gbumin@hacettepe.edu.tr",[58],{"facility":59,"status":35,"city":60,"state":61,"zip":35,"country":62,"countryCode":35,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Hacettepe University, Department of Occupational Therapy, Pediatric Unit","Ankara","Altındağ","Turkey (Türkiye)",{"type":64,"coordinates":65},"Point",[66,67],32.85427,39.91987,{"lat":67,"lon":66},[70],{"name":71,"role":50,"phone":72,"phoneExt":35,"email":52},"Ezginur Gündoğmuş","05384858392",{"type":74,"investigatorFullName":71,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Research assisstant","100622580","sensory-feeding-and-parent-coaching-for-children-with-arfid-100622580",false,"NCT07385469","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\u002FRestrictive Food Intake Disorder (ARFID): A Randomized Controlled Trial","SOS OPC ARFID","Inclusion Criteria:\n\n* Inclusion Criteria (for the child):\n\n  * 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).\n  * Being between the ages of 3 and 8.\n  * Being medically stable for outpatient treatment.\n  * Having no conditions (visual, auditory, cognitive, or chewing) that would prevent participation in treatment.\n\nInclusion Criteria (for the mother):\n\n* Being the child's primary caregiver and living with the mother.\n* Having at least a primary school diploma and possessing Turkish reading and comprehension proficiency.\n* Agreeing to take an active role in the intervention process and participate in research evaluations.\n* Being a regular participant in the child's feeding process.\n* Not having another child with special needs.\n\nExclusion Criteria:\n\n* Exclusion Criteria (Child):\n\n  * History of comorbid neurological, genetic, psychiatric, or metabolic disease\n  * Child and family receiving other individual or family-based education and\u002For psychotherapy during the intervention\n  * Taking medication for comorbid disorders affecting appetite and\u002For weight\n  * Active psychiatric crisis (e.g., severe anxiety disorder, post-traumatic stress disorder)\n  * Significant family or environmental constraints that would prevent regular attendance\n\nExclusion Criteria (Mother):\n\n* Severe hearing, vision, or cognitive impairment\n* Child concurrent participation in another intervention program (dietician, psychotherapy, group education, etc.) related to feeding behaviors\n* Presence of a chronic health condition (e.g., neurological, psychiatric, orthopedic, oncological, etc.) that would prevent regular attendance at the intervention","ALL","3 Years","8 Years",{"count":88,"type":89},60,"ESTIMATED","INTERVENTIONAL",[92],"NA","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.",[95],"ARFID",[95,97,98,99,100],"Eating Disorder","Occupational Therapy","Sensory Feeding","Occupational Performance Coaching","NOT_YET_RECRUITING","2026-06-10",{"date":104,"type":105},"2026-06-12","ACTUAL",{"date":107,"type":89},"2026-07-15",{"date":109,"type":89},"2026-07-30",{"name":5,"class":6},1]