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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
24/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/05/2024
Sample size
Target
Accrual to date
Final
20
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.


Results not provided in https://clinicaltrials.gov/study/NCT05852548