Autism Spectrum DisorderSOSNCT02435407
The Sequential Oral Sensory Approach for Limited Food Repertoire in Children With Autism Spectrum Disorder
A study testing SOS and Education in people with Autism Spectrum Disorder and Feeding Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder, Feeding Disorder, Restricted Diet
- What is being tested?
- SOS and Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- •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)
Who cannot join
- •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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8
About this study
Official title: The Sequential Oral Sensory (SOS) Intervention in Treating Children With Autism Spectrum Disorder and Limited Food Repertoire
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Feeding Disorder, Restricted Diet
- Being tested
- SOS, Education
- Medical subject headings
- Autism Spectrum Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOSBehavioural
Also called 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.
EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SOS arm | Experimental | The Sequential Oral Sensory (SOS) approach treatment protocol, involving systematic desensitization hierarchy of skills needed to build feeding skills. Receives: Behavioral: SOS |
| Education arm | Active comparator | Parents will participate in educational talks around the cause and management of feeding difficulties in children with autism spectrum disorder. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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
Measured: 12 weeks
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Sponsor
- Investigators
- Sharon Smile, MD, MSc., Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435407
- Sponsor's protocol ID
- REB file # 14-511
- Acronym
- SOS
- Status last verified
- May 2015
- First submitted
- 28 Apr 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sequential Oral Sensory (SOS) Intervention in Treating Children With Autism Spectrum Disorder and Limited Food Repertoire
- ClinicalTrials.gov ID
- NCT02435407
- Acronym / sponsor ID
- SOS / REB file # 14-511
- Conditions
- Autism Spectrum Disorder, Feeding Disorder, Restricted Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOS arm | Experimental | Behavioral: SOSThe Sequential Oral Sensory (SOS) approach treatment protocol, involving systematic desensitization hierarchy of skills needed to build feeding skills. |
| Education arm | Active comparator | Other: EducationParents will participate in educational talks around the cause and management of feeding difficulties in children with autism spectrum disorder. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- •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.
Key exclusion criteria (7 listed)
- •A child who has an anatomical cause for feeding problems such as cleft palate or significant oromotor abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOSAlso: Sequential Oral Sensory approachTen (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. | Behavioural | SOS arm |
| EducationParents 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. | Other | Education arm |
Primary outcome
Change in the number of foods eaten after 12 weeks of intervention as determined by the 3 day food diary
Time frame: 12 weeks
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.
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Smile, MD, MSc. principal investigator
Holland Bloorview Kids Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOS and Education in people with Autism Spectrum Disorder and Feeding Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2015.