Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07385469

Sensory Feeding and Parent Coaching for Children With ARFID

Conditions: ARFID

Sex: All
Ages: 3 Years – 8 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Hacettepe University

Location: Hacettepe University, Department of Occupational Therapy, Pediatric Unit Ankara Altındağ

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.

Eligibility Criteria

Inclusion Criteria: * 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: * 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07385469). StuddyBuddy aggregates publicly available trial information.