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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Behavioral Pediatric Feeding Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Waitlist (Behavioral)
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.
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
干预措施: SOS + Occupational Performance Coaching (OPC) (Behavioral)
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.
OPC 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.
In 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
干预措施: OPC Group (Behavioral)
The group that applied only the SOS approach for 60 minutes, once a week for 12 weeks
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
干预措施: Sequential Oral Sensory (SOS) Feeding Approach (Behavioral)
结局指标
主要结局
Behavioral Pediatric Feeding Scale
时间窗: 12 weeks
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
Children's Eating Behavior Questionnaire
时间窗: 12 weeks
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.
Sensory Eating Problems Scale
时间窗: 12 weeks
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.
Sensory Profile
时间窗: 12 weeks
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.
Goal Attainment Scale (GAS)
时间窗: 12 weeks
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.
次要结局
- Parental Feeding Style Questionnaire(12 weeks)
- Maternal Attitudes towards the Feeding Process Scale(12 weeks)
- Parenting Stress Index-Short Form(12 weeks)
研究者
Ezginur Gündoğmuş
Research assisstant
Hacettepe University