Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07385469 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Sensory Feeding and Parent Coaching for Children With ARFID

Study acronym: SOS OPC ARFID
StatusNot Yet Recruiting
PhaseNot applicable
Started2026-10-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jul 30, 2026 → Oct 30, 2026
See other at-risk trials from Hacettepe University

Amendment history

2026-09-16
notable
Primary completion pushed: 2026-07-30 → 2026-10-30
Completion pushed: 2026-07-30 → 2026-10-30
2026-06-10
notable
Study Status, Study Design, Arms and Interventions v1
Enrollment increased: 45 → 60 participants
Trial arms changed: 3 → 4
Primary completion pushed: 2026-03-30 → 2026-07-30
Completion pushed: 2026-04-30 → 2026-07-30
Start date2026-01-15→2026-07-15
InterventionsSOS + Occupational Performance Coaching (OPC) (Behavioral), Sequential Oral Sensory (SOS) Feeding Approach (Behavioral)→OPC Group (Behavioral), SOS + Occupational Performance Coaching (OPC) (Behavioral), Sequential Oral Sensory (SOS) Feeding Approach…
2026-01-29
minor
Original filing
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 Details
NCT Number NCT07385469
Lead Sponsor Hacettepe University
Conditions ARFID
Enrollment 60 participants
Start Date 2026-10-15
Primary Completion 2026-10-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-15