Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges, Australia Cohort

NCT05852548 | Completed

• 3 other identifiers: 2016-1428 AustraliaA176000EDUC\KINESIOLOGY\KINESIO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parent-Child Relations; Meals; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

• Change in Sensory Experiences Questionnaire (SEQ 3.0)

  Caregiver report instrument designed to characterize sensory features in children ages 2-12 years with ASD. This is a 105-item questionnaire, the scoring is based on the first 97: scored on a 5 point scale from 1 (almost never) to 5 (almost always). The remaining items are qualitative and provide context. Total possible range of scores is 97-485, higher scores indicate greater intensity of sensory behaviors.

  Pre/post measure through study completion, an average of 6 months

• Change in Goal Attainment Scaling (GAS)

  Assesses the effectiveness of psycho-social interventions in the community setting in ASD. The total possible range of standardized T scores is 23.56 - 76.44, where a score of 50 means all goals were met and higher scores indicate goals were exceeded.

  Pre/Post measure through study completion, an average of 6 months

• Change in Feeding and Eating in AutiSm Together Questionnaire

  Measures feeding challenges across domains of sensory, behavior, oral motor, and gastrointestinal as well as how feeding challenges present in daily life and family routines. The total possible range of scores for each domain is from 32-160 with higher scores indicating increased feeding challenge.

  Pre/Post measure through study completion, an average of 6 months

Secondary Outcomes (2)

• Change in the Caregiver Involvement Scale Score

  Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months)

• Change in Parent effort scale

  Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months)

Study Arms (1)

Parent-Mediated Intervention with ASD

EXPERIMENTAL

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

Interventions

Parent-Mediated Intervention BEHAVIORAL

Children with ASD will participate in a 6-month parent-mediated intervention that will include direct intervention and parent education.

Parent-Mediated Intervention with ASD

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child with a confirmed diagnosis of ASD (ages 2-7 years)
• Parent reported feeding problems
• English Speaking

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

La Trobe University

Melbourne, Victoria, Australia

Location

Related Publications (30)

• 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.

  PMID: 18775376 BACKGROUND

• Ledford JR, Gast DL. Feeding problems in children with autism spectrum disorders: A review. Focus Autism Other Dev Disabl. 2006;21(3):153-166

  BACKGROUND

• 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.

  PMID: 21599679 BACKGROUND

• 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.

  PMID: 23371510 BACKGROUND

• 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.

  PMID: 23531467 BACKGROUND

• 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.

  PMID: 19535467 BACKGROUND

• 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.

  PMID: 23889770 BACKGROUND

• 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.

  PMID: 19948568 BACKGROUND

• 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.

  PMID: 25346345 BACKGROUND

• 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.

  PMID: 23021480 BACKGROUND

• Manikam R, Perman JA. Pediatric feeding disorders. J Clin Gastroenterol. 2000 Jan;30(1):34-46. doi: 10.1097/00004836-200001000-00007.

  PMID: 10636208 BACKGROUND

• 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.

  PMID: 20597379 BACKGROUND

• 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.

  PMID: 11794415 BACKGROUND

• 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.

  PMID: 18483843 BACKGROUND

• 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.

  PMID: 15449518 BACKGROUND

• 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.

  PMID: 20484003 BACKGROUND

• 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.

  PMID: 20608859 BACKGROUND

• 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.

  PMID: 20146741 BACKGROUND

• 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.

  PMID: 16430729 BACKGROUND

• 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.

  PMID: 18056140 BACKGROUND

• 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.

  PMID: 19748900 BACKGROUND

• 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.

  PMID: 25648749 BACKGROUND

• 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.

  PMID: 20362301 BACKGROUND

• 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.

  PMID: 20053272 BACKGROUND

• 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.

  PMID: 21161576 BACKGROUND

• Pfeiffer B, Kinnealey M. Treatment of sensory defensiveness in adults. Occup Ther Int. 2003;10(3):175-84. doi: 10.1002/oti.184.

  PMID: 12900790 BACKGROUND

• 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.

  PMID: 21667199 BACKGROUND

• 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.

  PMID: 22271197 BACKGROUND

• 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.

  PMID: 8195550 BACKGROUND

• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

  PMID: 16204405 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Karla K Ausderau, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: One group, pre, post-test

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 10, 2023
• Study Start: June 24, 2023
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)