The Sequential Oral Sensory Approach for Limited Food Repertoire in Children With Autism Spectrum Disorder

NCT02435407 | Unknown

• 1 other identifier: REB file # 14-511
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Feeding Disorder; Restricted Diet

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  12 weeks

• Description of the sensory profiles of participants as determined by the Short Sensory Profile- short form Questionnaire

  At baseline

Other Outcomes (1)

• To determine parental satisfaction as determined by the Canadian Occupation Performance Measure

  12 weeks

Study Arms (2)

SOS arm

EXPERIMENTAL

The Sequential Oral Sensory (SOS) approach treatment protocol, involving systematic desensitization hierarchy of skills needed to build feeding skills.

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.

Other: Education

Interventions

SOS BEHAVIORAL

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.

Also known as: Sequential Oral Sensory approach

SOS arm

Education OTHER

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.

Education arm

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• The Hospital for Sick Children: collaborator

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Feeding and Eating Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Sharon Smile, MD, MSc.

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 6, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 29, 2015

Record last verified: 2015-05

Locations

CA (1)