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Trial registered on ANZCTR


Registration number
ACTRN12611000722998
Ethics application status
Approved
Date submitted
11/07/2011
Date registered
12/07/2011
Date last updated
30/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Eating Learning Program (HELP) Study for Children with Autism Spectrum Disorder
Scientific title
In children with Autism Spectrum Disorder and feeding difficulties, is traditional operant conditioning intervention more effective than novel systematic desensitisation intervention at improving dietary variety and nutrition, and decreasing maladaptive mealtime behaviours and parental stress?
Secondary ID [1] 262257 0
Nil
Universal Trial Number (UTN)
U1111-1121-7588
Trial acronym
HELP study for children with ASD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 267954 0
Feeding Difficulties 267988 0
Condition category
Condition code
Mental Health 268092 268092 0 0
Autistic spectrum disorders
Diet and Nutrition 268093 268093 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm One: One-on-one behaviour modification therapy Run in an individual session for 1 hour per week over ten weeks (weekly schedule) or 10 times over one week (intensive schedule) Involves providing a verbal prompt to encourage consumption of spoonfuls of new food/s, with positive reinforcement (verbal and/or with toys etc) upon consumption of these foods. Parents initially observe from behind a one-way mirror and assist in collecting information about the behaviours they are observing in their child. As sessions continue, parents are transitioned into the room, and are trained to offer new foods and provide positive reinforcement by the end of the therapy block. Parents also receive standardised information about nutrition, behaviour management and feeding development. Arm Two: Systematic desensitisation therapy Run in an individual session for 1 hour per week over ten weeks (weekly schedule) or 10 times in one week (intensive schedule) Involves the child being exposed to gradually more challenging modelling and play with food (based on a sensory hierarchy of look>touch>smell>taste). Parents initially observe the sessions from behind a one-way mirror with a second therapist and assist in observing transitions and reactions in their children. As the block continues, parents are rotated in and out of the room to assist in modelling play using the sensory hierarchy. Parents also receive standardised information about nutrition, behaviour management and feeding development.
Intervention code [1] 266649 0
Behaviour
Intervention code [2] 266650 0
Treatment: Other
Comparator / control treatment
Natural control will be waiting for therapy. These children will either be offered input via an intensive schedule (as described above) or during a subsequent 10-week block. As recruitment for this study will occur in an ongoing fashion, there will be multiple opportunities to access therapy if it is not immediately available.
Control group
Active

Outcomes
Primary outcome [1] 266835 0
Adequacy of diet and overall increase in dietary variety

Assessed via 3-day weighed food diary, modified Children's Dietary Questionnaire (Magarey et al. 1999)(food frequency questionnaire) and New Food Lists, where parents indicate in an ongoing fashion how many times their child is offered new foods and the number of acceptances or rejections
Timepoint [1] 266835 0
Mid-intervention
Immediately post-intervention
3 months post-intervention
Primary outcome [2] 266836 0
Growth (change in weight and height)
Timepoint [2] 266836 0
Immediately post-intervention
3 months post-intervention
Primary outcome [3] 266837 0
Change in fat-free mass as measured by body composition measures Measured via Bioelectrical Impedance Analysis and Total Body Potassium Measurement
Timepoint [3] 266837 0
Immediately post-intervention
3 months post-intervention
Secondary outcome [1] 276482 0
Improvement in mealtime behaviours (% desirable vs undesirable behaviours; mealtime duration)

Measured via Behaviour Pediatrics Feeding Assessment (Adapted from Crist et al. 2001), and self-developed HELP study: Eating Skills and Behaviours Questionnaire. Questionnaires involve parent-rated likert scales (parents rate level of concern).
Timepoint [1] 276482 0
Immediately post-intervention
3 months post-intervention
Secondary outcome [2] 276532 0
Improvement in mealtime interactions between parent and child

Measured via Dyadic Parent-Child Interaction Coding System (Revised) (Eyberg, 1994). A video-tape is taken of the parent interacting with their child in a non-food related activity, a parent offering their child a preferred food, and the parent offering their child a non-preferred food. All videos will be rated externally by the team psychologist who will not be working directly with the children involved.
Timepoint [2] 276532 0
3 months post-intervention
Secondary outcome [3] 276533 0
Improvement in parental stress (overall and mealtime specific)

Measured via self-developed HELP study: Parent percieved stress questionnaire and the Parenting Stress Index - Short Form.
Timepoint [3] 276533 0
Immediately post-intervention
3 months post-intervention
Secondary outcome [4] 276534 0
Increased interest in trying unfamiliar foods

Measured with Children's Picky Eating Questionnaire (Adapted from Carruth and Skinner, 2000) and New Foods Lists, where parents indicate in an ongoing fashion how many times their child is offered new foods and the number of acceptances or rejections.
Timepoint [4] 276534 0
Immediately post-intervention
3 months post-intervention

Eligibility
Key inclusion criteria
Children with a diagnosis of Autism Spectrum Disorder, or a pending diagnosis of Autism Spectrum Disorder

Limited dietary variety across core food groups: diet currently includes less than 10 foods which are predominantly carbohydrates, 10 foods which are predominantly proteins, and 10 fruits/vegetables; limited range of textures consumed; don’t eat an age-appropriate range of textures; limit diet to only 1 or 2 textures of foods; consume predominantly ‘easy-to-eat’ junk foods

Mealtimes are taking longer than 30 minutes

There are problematic behaviours at mealtimes, which are contributing to parental stress
Minimum age
1 Years
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who are medically unstable: this describes acutely unwell children who may experience a deterioration in health.

Children with documented aspiration on any solid food textures (children on modified liquids will be accepted)

Children with severe malnutrition, whose primary goal of nutrition could only be achieved by supplementary tube feeding

Children with gut malabsorption disorders, which are not well controlled or understood

Children with an allergy or current intolerance to more than 2 types of foods

Children whose primary health carer has a known/declared mental health condition

Children whose family’s primary language is that other than English or children identified as being of Aboriginal or Torres Strait Islander background

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomly generated numbers have been placed in sealed envelopes by a colleague who is not involved with the study. After children have received their initial assessment and are deemed eligible to receive intervention, the next envelope in the sequence will be opened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number sequence will be used to allocate the numbers to sealed envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Inter-rater reliability for assessments where 10% of video-taped assessments requiring objective scoring will be reviewed by a blind clinician.

Coders for dietary variety measures and parent-child interaction measures will be blinded.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4046 0
4029

Funding & Sponsors
Funding source category [1] 267138 0
Hospital
Name [1] 267138 0
Queensland Children's Medical Research Institute, Royal Children's Hospital
Address [1] 267138 0
Queensland Children's Medical Research Institute
Level 4, Foundation Building, Royal Children's Hospital, Herston Road, Herston QLD 4029
Country [1] 267138 0
Australia
Funding source category [2] 267139 0
Self funded/Unfunded
Name [2] 267139 0
Jeanne Marshall
Address [2] 267139 0
Queensland Children's Medical Research Institute
Level 4, Foundation Building, Royal Children's Hospital, Herston Road, Herston Queensland 4029
Country [2] 267139 0
Australia
Funding source category [3] 269778 0
University
Name [3] 269778 0
The University of Queensland
Address [3] 269778 0
St. Lucia, Queensland 4068
Country [3] 269778 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Medical Research Institute
Royal Children's Hospital
Address
Level 4, Foundation Building, Royal Children's Hospital, Herston Road, Herston Queensland 4029
Country
Australia
Secondary sponsor category [1] 264214 0
Government body
Name [1] 264214 0
Queensland Health
Address [1] 264214 0
Health Research Fellowship for Dr. Pamela Dodrill
Speech Pathology Department
Royal Children's Hospital
Herston Road
Herston
Queensland
4029
Country [1] 264214 0
Australia
Secondary sponsor category [2] 268820 0
University
Name [2] 268820 0
The University of Queensland
Address [2] 268820 0
St. Lucia, Queensland 4068
Country [2] 268820 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269127 0
Children's Health Services Human Research Ethics Committee (EC00175)
Ethics committee address [1] 269127 0
c/ Department of Paediatrics & Child Health
Level 3, Foundation Building
Royal Children's Hospital
Herston Road
HERSTON QLD 4029
Ethics committee country [1] 269127 0
Australia
Date submitted for ethics approval [1] 269127 0
10/05/2010
Approval date [1] 269127 0
12/05/2010
Ethics approval number [1] 269127 0
HREC/10/QRCH/30
Ethics committee name [2] 269128 0
Delete
Ethics committee address [2] 269128 0
Delete
Ethics committee country [2] 269128 0
Date submitted for ethics approval [2] 269128 0
01/08/2010
Approval date [2] 269128 0
01/03/2011
Ethics approval number [2] 269128 0
1575C
Ethics committee name [3] 269129 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [3] 269129 0
Human Ethics Unit
The University of Queensland
St. Lucia QLD 4068
Ethics committee country [3] 269129 0
Australia
Date submitted for ethics approval [3] 269129 0
10/05/2010
Approval date [3] 269129 0
12/05/2010
Ethics approval number [3] 269129 0
2010000677

Summary
Brief summary
This study is a randomised controlled trial to evaluate the clinical benefits, and cost-effectiveness of two feeding treatment programs for children with ASD and feeding difficulties, including a restricted range of dietary intake (<30 foods across the food groups). Baseline assessment will include parent-completed questionnaires and on-site (Herston) feeding and growth assessments. There are two arms of intervention. Arm One is an individual behaviour modification program. Arm Two involves individual systematic desensitisation therapy. Both arms will involve parent education regarding nutrition and behaviour management for children with feeding difficulties. Intervention will be provided over two phases. Parents will elect to participate in weekly intervention (10 sessions over 10 weeks) or intensive intervention (10 sessions over one week).
Trial website
www.qcmri.org.au
Trial related presentations / publications
Blank
Public notes

Contacts
Principal investigator
Name 32658 0
Dr Pamela Dodrill
Address 32658 0
Queensland Children's Medical Research Institute
Level 4, Foundation Building, Royal Children's Hospital
Herston Brisbane
Australia
4029
Country 32658 0
Australia
Phone 32658 0
+61 7 3636 6107
Fax 32658 0
Email 32658 0
p.dodrill@uq.edu.au
Contact person for public queries
Name 15905 0
Mrs Jeanne Marshall
Address 15905 0
Queensland Children's Medical Research Institute
Level 4, Foundation Building, Royal Children's Hospital, Herston Road, Herston Queensland 4029
Country 15905 0
Australia
Phone 15905 0
+61 7 3636 1290
Fax 15905 0
+61 7 3636 5578
Email 15905 0
j.marshall@uq.edu.au
Contact person for scientific queries
Name 6833 0
Mrs Jeanne Marshall
Address 6833 0
Queensland Children's Medical Research Institute
Level 4, Foundation Building, Royal Children's Hospital, Herston Road, Herston Queensland 4029
Country 6833 0
Australia
Phone 6833 0
+61 7 3636 1290
Fax 6833 0
+61 7 3636 5578
Email 6833 0
j.marshall@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary