Overview

This trial is active, not recruiting.

Conditions autism spectrum disorder, feeding disorder, restricted diet
Treatments sos, education
Sponsor Holland Bloorview Kids Rehabilitation Hospital
Collaborator The Hospital for Sick Children
Start date January 2015
End date September 2015
Trial size 20 participants
Trial identifier NCT02435407, REB file # 14-511

Summary

There is a paucity of research evaluating the effectiveness of a multidisciplinary approach in an outpatient clinic setting in the management of feeding problems in children diagnosed with ASD. Current behavioural interventions geared to address this problem can be labour intensive and costly. The SOS approach for managing feeding problems in children has been adopted internationally. Thus establishing its effectiveness will be useful in providing evidenced based interventions for feeding difficulties in ASD.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The Sequential Oral Sensory (SOS) approach treatment protocol, involving systematic desensitization hierarchy of skills needed to build feeding skills.
sos Sequential Oral Sensory approach
Ten (10) children will be randomized to participate in the SOS intervention arm. The intervention will be divided into two groups of 5 children with 2 therapists assigned. The children will attend 1 hour intervention sessions once a week for 12 weeks. Here they will be introduced to different types of foods that they would not have typically eaten in a play based group session. The SOS intervention utilizes the principle of hierarchal desensitization.
(Active Comparator)
Parents will participate in educational talks around the cause and management of feeding difficulties in children with autism spectrum disorder.
education
Parents will be given three 1 hour educational talks around the aetiology and management of feeding difficulties in children with autism spectrum disorder. This will be administered at 3 distinct time points; baseline, week 6 and week 12 of the study.

Primary Outcomes

Measure
Change in the number of foods eaten after 12 weeks of intervention as determined by the 3 day food diary
time frame: 12 weeks

Secondary Outcomes

Measure
Change in the level of parental stress around meal times after 12 weeks of intervention as determined by the Parent Stress Index questionnaire
time frame: 12 weeks
Description of the sensory profiles of participants as determined by the Short Sensory Profile- short form Questionnaire
time frame: At baseline

Eligibility Criteria

Male or female participants from 4 years up to 8 years old.

Inclusion Criteria: - •Children diagnosed with Autism Spectrum Disorder based upon an Autism Diagnostic Observation Schedule12 (ADOS) and Diagnostic and Statistical Manual (DSM)-IV or DSM-V interview. - Age 48 months - 96 months - Child who is physically able to observe others in a group setting - Children identified as having limited food repertoire < 20 food in dietary repertoire - Test of Adaptive function: Vineland Adaptive Behavioural Scale- 2nd Edition form13 - Child and caregiver/ parent committed to attend 12 sessions - Parents are fluent in English - Parent total Difficult Child score on the Parental Stress Index short form14 is above the 90th percentile (which is deemed clinically significant) Exclusion Criteria: - •A child who has an anatomical cause for feeding problems such as cleft palate or significant oromotor abnormality - Child diagnosed with failure to thrive - Child who is unable to sit at the table during mealtime - Child with significant motor difficulties - Children in foster care - Participation in concurrent feeding clinic/ intervention - Child with moderate to severe cognitive/intellectual impairment

Additional Information

Official title The Sequential Oral Sensory (SOS) Intervention in Treating Children With Autism Spectrum Disorder and Limited Food Repertoire
Principal investigator Sharon Smile, MD, MSc.
Description Feeding problems in children diagnosed with autism spectrum disorder (ASD) has been found to vary from 46-89%, with significant variability in feeding patterns. Feeding problems can lead to failure to thrive, nutritional deficiencies, growth retardation, social deficits and poor academic achievements. Common feeding problems are typified by limited food repertoire, food refusal and high frequency single food intake. The etiology of feeding problems in children with ASD is multifactorial and includes sensory issues, perseveration, avoidance of novel stimuli and food intolerance. No single aetiology has been assigned to limited food repertoire in children diagnosed with ASD. A recent meta-analysis of feeding problems and nutritional intake in children diagnosed with ASD reveals that children with ASD had more feeding problems when compared to peers (odds ratio 5.11, 95% Confidence interval (CI) 3.74-6.97). There was significantly lower intake of calcium and protein. Children diagnosed with ASD have limited food repertoire compared to typically developing children (19.0 (5.0) foods eaten vs. 22.5 (4.6) foods eaten, p value 0.0003) and they have evidence of nutritional inadequacies and poor bone growth. The impact of feeding problems extends to the home environment and may contribute to parental stress and affect bonding/ attachment of child to caregiver during mealtimes. This phenomena has not been explored in depth in current research. Behavioural intervention using an interdisciplinary team model is the hallmark intervention for the treatment of feeding problems in children diagnosed with ASD. However there is limited research data available in this field. Behavioural intervention approaches described in the literature include stimulus control, positive reinforcement, negative reinforcement, discrimination training, extinction, punishment and desensitization. Positive reinforcement-based intervention, physical guidance, and non-removal of the spoon are techniques which have found to be useful based on case reports. These interventions require highly structured environments, are costly and at times parents are not involved in the management plan, thus limiting generalizability. There is no consensus regarding which technique is superior and more effective. There are three published interventional studies which directly address feeding problems in ASD. These span from intensive inpatient management to behavioural patient based curriculum. A retrospective chart review of 37 children over a 2 year period seen in group intervention sessions using the Sequential Oral Sensory (SOS) approach showed some promise in increasing food variability and intake. The Sequential Oral Sensory (SOS) approach is a multidisciplinary program for assessing and treating children with feeding and weight problems. This program uses a systematic desensitization hierarchy of skills necessary for children to progress with eating various food textures. The technique is patient controlled, where the patient is "allowed to move away" from the exposure. The goal of the therapy is to maintain a competing response in the face of increasing incremental exposures. The SOS approach if effective presents a more affordable treatment option, in a natural outpatient setting and utilizes parental participation under supervision which may translate to generalizability to the home environment. Given the prevalence of feeding challenges in ASD exploring this option should be undertaken given its suggested implications.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Holland Bloorview Kids Rehabilitation Hospital.