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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
Date last updated
21/05/2024

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
The goal is to expand a parent-mediated intervention for feeding challenges in children with autism with an Australian cohort, building on recent research and current successful models already being used. A parent-mediated intervention would primarily occur in the home environment, working with the parent to establish goals and implement the intervention based on their child's specific needs.
Trial website
https://clinicaltrials.gov/study/NCT05852548
Trial related presentations / publications
Kodak T, Piazza CC. Assessment and behavioral treatment of feeding and sleeping disorders in children with autism spectrum disorders. Child Adolesc Psychiatr Clin N Am. 2008 Oct;17(4):887-905, x-xi. doi: 10.1016/j.chc.2008.06.005.
Ledford JR, Gast DL. Feeding problems in children with autism spectrum disorders: A review. Focus Autism Other Dev Disabl. 2006;21(3):153-166
Marquenie K, Rodger S, Mangohig K, Cronin A. Dinnertime and bedtime routines and rituals in families with a young child with an autism spectrum disorder. Aust Occup Ther J. 2011 Jun;58(3):145-54. doi: 10.1111/j.1440-1630.2010.00896.x. Epub 2011 Jan 9.
Sharp WG, Berry RC, McCracken C, Nuhu NN, Marvel E, Saulnier CA, Klin A, Jones W, Jaquess DL. Feeding problems and nutrient intake in children with autism spectrum disorders: a meta-analysis and comprehensive review of the literature. J Autism Dev Disord. 2013 Sep;43(9):2159-73. doi: 10.1007/s10803-013-1771-5.
Kral TV, Eriksen WT, Souders MC, Pinto-Martin JA. Eating behaviors, diet quality, and gastrointestinal symptoms in children with autism spectrum disorders: a brief review. J Pediatr Nurs. 2013 Nov-Dec;28(6):548-56. doi: 10.1016/j.pedn.2013.01.008. Epub 2013 Mar 24.
Estes A, Munson J, Dawson G, Koehler E, Zhou XH, Abbott R. Parenting stress and psychological functioning among mothers of preschool children with autism and developmental delay. Autism. 2009 Jul;13(4):375-87. doi: 10.1177/1362361309105658.
Lovell B, Moss M, Wetherell MA. The psychophysiological and health corollaries of child problem behaviours in caregivers of children with autism and ADHD. J Intellect Disabil Res. 2015 Feb;59(2):150-7. doi: 10.1111/jir.12081. Epub 2013 Jul 24.
Dawson G, Rogers S, Munson J, Smith M, Winter J, Greenson J, Donaldson A, Varley J. Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model. Pediatrics. 2010 Jan;125(1):e17-23. doi: 10.1542/peds.2009-0958. Epub 2009 Nov 30.
Hardan AY, Gengoux GW, Berquist KL, Libove RA, Ardel CM, Phillips J, Frazier TW, Minjarez MB. A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism. J Child Psychol Psychiatry. 2015 Aug;56(8):884-92. doi: 10.1111/jcpp.12354. Epub 2014 Oct 27.
Rogers SJ, Estes A, Lord C, Vismara L, Winter J, Fitzpatrick A, Guo M, Dawson G. Effects of a brief Early Start Denver model (ESDM)-based parent intervention on toddlers at risk for autism spectrum disorders: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012 Oct;51(10):1052-65. doi: 10.1016/j.jaac.2012.08.003. Epub 2012 Aug 28.
Manikam R, Perman JA. Pediatric feeding disorders. J Clin Gastroenterol. 2000 Jan;30(1):34-46. doi: 10.1097/00004836-200001000-00007.
Winston KA, Dunbar SB, Reed CN, Francis-Connolly E. Mothering occupations when parenting children with feeding concerns: a mixed methods study. Can J Occup Ther. 2010 Jun;77(3):181-9. doi: 10.2182/cjot.2010.77.3.8.
Ahearn WH, Castine T, Nault K, Green G. An assessment of food acceptance in children with autism or pervasive developmental disorder-not otherwise specified. J Autism Dev Disord. 2001 Oct;31(5):505-11. doi: 10.1023/a:1012221026124.
Martins Y, Young RL, Robson DC. Feeding and eating behaviors in children with autism and typically developing children. J Autism Dev Disord. 2008 Nov;38(10):1878-87. doi: 10.1007/s10803-008-0583-5. Epub 2008 May 16.
Schreck KA, Williams K, Smith AF. A comparison of eating behaviors between children with and without autism. J Autism Dev Disord. 2004 Aug;34(4):433-8. doi: 10.1023/b:jadd.0000037419.78531.86.
Nadon G, Feldman DE, Dunn W, Gisel E. Mealtime problems in children with autism spectrum disorder and their typically developing siblings: a comparison study. Autism. 2011 Jan;15(1):98-113. doi: 10.1177/1362361309348943. Epub 2010 May 18.
Provost B, Crowe TK, Osbourn PL, McClain C, Skipper BJ. Mealtime behaviors of preschool children: comparison of children with autism spectrum disorder and children with typical development. Phys Occup Ther Pediatr. 2010 Aug;30(3):220-33. doi: 10.3109/01942631003757669.
Dabrowska A, Pisula E. Parenting stress and coping styles in mothers and fathers of pre-school children with autism and Down syndrome. J Intellect Disabil Res. 2010 Mar;54(3):266-80. doi: 10.1111/j.1365-2788.2010.01258.x. Epub 2010 Feb 8.
Lecavalier L, Leone S, Wiltz J. The impact of behaviour problems on caregiver stress in young people with autism spectrum disorders. J Intellect Disabil Res. 2006 Mar;50(Pt 3):172-83. doi: 10.1111/j.1365-2788.2005.00732.x.
Greer AJ, Gulotta CS, Masler EA, Laud RB. Caregiver stress and outcomes of children with pediatric feeding disorders treated in an intensive interdisciplinary program. J Pediatr Psychol. 2008 Jul;33(6):612-20. doi: 10.1093/jpepsy/jsm116. Epub 2007 Dec 3.
Laud RB, Girolami PA, Boscoe JH, Gulotta CS. Treatment outcomes for severe feeding problems in children with autism spectrum disorder. Behav Modif. 2009 Sep;33(5):520-36. doi: 10.1177/0145445509346729. Epub 2009 Sep 10.
Baranek GT, Watson LR, Turner-Brown L, Field SH, Crais ER, Wakeford L, Little LM, Reznick JS. Preliminary efficacy of adapted responsive teaching for infants at risk of autism spectrum disorder in a community sample. Autism Res Treat. 2015;2015:386951. doi: 10.1155/2015/386951. Epub 2015 Jan 11.
Bandini LG, Anderson SE, Curtin C, Cermak S, Evans EW, Scampini R, Maslin M, Must A. Food selectivity in children with autism spectrum disorders and typically developing children. J Pediatr. 2010 Aug;157(2):259-64. doi: 10.1016/j.jpeds.2010.02.013. Epub 2010 Apr 1.
Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1. Erratum In: BMC Med Res Methodol. 2023 Mar 11;23(1):59. doi: 10.1186/s12874-023-01880-1.
Boyd BA, McDonough SG, Rupp B, Khan F, Bodfish JW. Effects of a family-implemented treatment on the repetitive behaviors of children with autism. J Autism Dev Disord. 2011 Oct;41(10):1330-41. doi: 10.1007/s10803-010-1156-y.
Pfeiffer B, Kinnealey M. Treatment of sensory defensiveness in adults. Occup Ther Int. 2003;10(3):175-84. doi: 10.1002/oti.184.
Schaaf R, Blanche EI. Comparison of behavioral intervention and sensory-integration therapy in the treatment of challenging behavior. J Autism Dev Disord. 2011 Oct;41(10):1436-8; author reply 1439-41. doi: 10.1007/s10803-011-1303-0. No abstract available.
Ruble L, McGrew JH, Toland MD. Goal attainment scaling as an outcome measure in randomized controlled trials of psychosocial interventions in autism. J Autism Dev Disord. 2012 Sep;42(9):1974-83. doi: 10.1007/s10803-012-1446-7.
Crawford PB, Obarzanek E, Morrison J, Sabry ZI. Comparative advantage of 3-day food records over 24-hour recall and 5-day food frequency validated by observation of 9- and 10-year-old girls. J Am Diet Assoc. 1994 Jun;94(6):626-30. doi: 10.1016/0002-8223(94)90158-9.
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05852548