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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05852548




Registration number
NCT05852548
Ethics application status
Date submitted
28/04/2023
Date registered
10/05/2023

Titles & IDs
Public title
Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges, Australia Cohort
Scientific title
Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges, Australia Cohort
Secondary ID [1] 0 0
A176000
Secondary ID [2] 0 0
2016-1428 Australia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parent-Child Relations 0 0
Meals 0 0
Autism Spectrum Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Parent-Mediated Intervention

Experimental: Parent-Mediated Intervention with ASD - In-home intervention (1-2x/week) will occur with families with children with ASD, including direct intervention, parent coaching, and parent training.


BEHAVIORAL: Parent-Mediated Intervention
Children with ASD will participate in a 6-month parent-mediated intervention that will include direct intervention and parent education.

Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Sensory Experiences Questionnaire (SEQ 3.0)
Timepoint [1] 0 0
Pre/post measure through study completion, an average of 6 months
Primary outcome [2] 0 0
Change in Goal Attainment Scaling (GAS)
Timepoint [2] 0 0
Pre/Post measure through study completion, an average of 6 months
Primary outcome [3] 0 0
Change in Feeding and Eating in AutiSm Together Questionnaire
Timepoint [3] 0 0
Pre/Post measure through study completion, an average of 6 months
Secondary outcome [1] 0 0
Change in the Caregiver Involvement Scale Score
Timepoint [1] 0 0
Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months)
Secondary outcome [2] 0 0
Change in Parent effort scale
Timepoint [2] 0 0
Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months)

Eligibility
Key inclusion criteria
* Child with a confirmed diagnosis of ASD (ages 2-7 years)
* Parent reported feeding problems
* English Speaking
Minimum age
2 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any conditions co-morbid with ASD (e.g., fragile X)
* Significant visual, hearing or physical impairments
* Children who receive any non-oral nutritional supplementation (e.g. gastrostomy tubes)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
VIC
Recruitment hospital [1] 0 0
La Trobe University - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Wisconsin, Madison
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karla K Ausderau, PhD
Address 0 0
University of Wisconsin, Madison
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.