The Sequential Oral Sensory Approach for Limited Food Repertoire in Children With Autism Spectrum Disorder (SOS)
Primary Purpose
Autism Spectrum Disorder, Feeding Disorder, Restricted Diet
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SOS
Education
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
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
Sites / Locations
- Holland Bloorview Kids Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SOS arm
Education arm
Arm Description
The Sequential Oral Sensory (SOS) approach treatment protocol, involving systematic desensitization hierarchy of skills needed to build feeding skills.
Parents will participate in educational talks around the cause and management of feeding difficulties in children with autism spectrum disorder.
Outcomes
Primary Outcome Measures
Change in the number of foods eaten after 12 weeks of intervention as determined by the 3 day food diary
The primary aim of the current proposal is to evaluate the effectiveness of the SOS Approach intervention for increasing the food repertoire in children diagnosed with ASD and limited food repertoire. A 12 week, unblinded randomized controlled trial of SOS approach intervention matched by age will be conducted. Following a screening visit, subjects assigned to the intervention group will return at baseline and then weekly for 12 weeks.
Secondary Outcome Measures
Change in the level of parental stress around meal times after 12 weeks of intervention as determined by the Parent Stress Index questionnaire
The secondary study aim is to investigate if participation in the SOS approach intervention will lead to decreased parental stress around mealtime feeding
Description of the sensory profiles of participants as determined by the Short Sensory Profile- short form Questionnaire
To investigate the sensory profiles of subjects participating in the study.
Full Information
NCT ID
NCT02435407
First Posted
April 28, 2015
Last Updated
September 28, 2015
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT02435407
Brief Title
The Sequential Oral Sensory Approach for Limited Food Repertoire in Children With Autism Spectrum Disorder
Acronym
SOS
Official Title
The Sequential Oral Sensory (SOS) Intervention in Treating Children With Autism Spectrum Disorder and Limited Food Repertoire
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Feeding Disorder, Restricted Diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SOS arm
Arm Type
Experimental
Arm Description
The Sequential Oral Sensory (SOS) approach treatment protocol, involving systematic desensitization hierarchy of skills needed to build feeding skills.
Arm Title
Education arm
Arm Type
Active Comparator
Arm Description
Parents will participate in educational talks around the cause and management of feeding difficulties in children with autism spectrum disorder.
Intervention Type
Behavioral
Intervention Name(s)
SOS
Other Intervention Name(s)
Sequential Oral Sensory approach
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
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 Outcome Measure Information:
Title
Change in the number of foods eaten after 12 weeks of intervention as determined by the 3 day food diary
Description
The primary aim of the current proposal is to evaluate the effectiveness of the SOS Approach intervention for increasing the food repertoire in children diagnosed with ASD and limited food repertoire. A 12 week, unblinded randomized controlled trial of SOS approach intervention matched by age will be conducted. Following a screening visit, subjects assigned to the intervention group will return at baseline and then weekly for 12 weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in the level of parental stress around meal times after 12 weeks of intervention as determined by the Parent Stress Index questionnaire
Description
The secondary study aim is to investigate if participation in the SOS approach intervention will lead to decreased parental stress around mealtime feeding
Time Frame
12 weeks
Title
Description of the sensory profiles of participants as determined by the Short Sensory Profile- short form Questionnaire
Description
To investigate the sensory profiles of subjects participating in the study.
Time Frame
At baseline
Other Pre-specified Outcome Measures:
Title
To determine parental satisfaction as determined by the Canadian Occupation Performance Measure
Description
To assess parents satisfaction with their child's performance during meals after participating in the SOS intervention.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Smile, MD, MSc.
Organizational Affiliation
Holland Bloorview Kids Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R8
Country
Canada
12. IPD Sharing Statement
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The Sequential Oral Sensory Approach for Limited Food Repertoire in Children With Autism Spectrum Disorder
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