Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-04-24 @ 8:05 PM
Study NCT ID:
NCT03071120
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One group, pre, post-test'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2017-02-28', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Brief Autism Mealtime Behavior Inventory (BAMBIC)', 'timeFrame': 'Pre/post measure through study completion, an average of 6 months', 'description': 'Parent report 18 item inventory that uses a Likert scale (1 = never to 5 = always) to report frequency of mealtime problem behaviors in children. Total possible range of scores is 18-90 where higher scores indicate increased frequency of mealtime problems.'}, {'measure': 'Change in Sensory Experiences Questionnaire (SEQ 3.0)', 'timeFrame': 'Pre/post measure through study completion, an average of 6 months', 'description': '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.'}, {'measure': 'Change in Behavioral Pediatric Feeding Assessment Scale (BPFAS)', 'timeFrame': 'Pre/post measure through study completion, an average of 6 months', 'description': 'Parent report measure designed to identify mealtime behaviors'}, {'measure': 'Change in Goal Attainment Scaling (GAS).', 'timeFrame': 'Pre/Post measure through study completion, an average of 6 months', 'description': 'Assesses the effectiveness of psycho-social interventions in the community setting in ASD.'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory-II (BDI)', 'timeFrame': 'Pre/post measure through study completion, an average of 6 months', 'description': 'Used to assess parent depression and stress.'}, {'measure': 'Parenting Stress Index-Short Form (PSI-SF)', 'timeFrame': 'Pre/post measure through study completion, an average of 6 months', 'description': 'Used to assess parent depression and stress.'}, {'measure': 'Change in the Caregiver Involvement Scale Score', 'timeFrame': 'Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months)', 'description': 'The Caregiver Involvement Scale is a 6-item instrument scored on a 5-point likert scale for a total possible range of scores from 6-30, where higher scores indicate increased caregiver comfort and involvement with the intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parent-Child Relations', 'Meals', 'Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '18775376', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Ledford JR, Gast DL. Feeding problems in children with autism spectrum disorders: A review. Focus Autism Other Dev Disabl. 2006;21(3):153-166'}, {'pmid': '21599679', 'type': 'BACKGROUND', 'citation': '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': '23371510', 'type': 'BACKGROUND', 'citation': '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': '23531467', 'type': 'BACKGROUND', 'citation': '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': '19535467', 'type': 'BACKGROUND', 'citation': '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': '23889770', 'type': 'BACKGROUND', 'citation': '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': '19948568', 'type': 'BACKGROUND', 'citation': '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': '25346345', 'type': 'BACKGROUND', 'citation': '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': '23021480', 'type': 'BACKGROUND', 'citation': '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': '10636208', 'type': 'BACKGROUND', 'citation': 'Manikam R, Perman JA. Pediatric feeding disorders. J Clin Gastroenterol. 2000 Jan;30(1):34-46. doi: 10.1097/00004836-200001000-00007.'}, {'pmid': '20597379', 'type': 'BACKGROUND', 'citation': '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': '11794415', 'type': 'BACKGROUND', 'citation': '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': '18483843', 'type': 'BACKGROUND', 'citation': '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': '15449518', 'type': 'BACKGROUND', 'citation': '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': '20484003', 'type': 'BACKGROUND', 'citation': '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': '20608859', 'type': 'BACKGROUND', 'citation': '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': '20146741', 'type': 'BACKGROUND', 'citation': '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': '16430729', 'type': 'BACKGROUND', 'citation': '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': '18056140', 'type': 'BACKGROUND', 'citation': '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': '19748900', 'type': 'BACKGROUND', 'citation': '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': '25648749', 'type': 'BACKGROUND', 'citation': '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': '20362301', 'type': 'BACKGROUND', 'citation': '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': '20053272', 'type': 'BACKGROUND', 'citation': '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': '21161576', 'type': 'BACKGROUND', 'citation': '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': '12900790', 'type': 'BACKGROUND', 'citation': 'Pfeiffer B, Kinnealey M. Treatment of sensory defensiveness in adults. Occup Ther Int. 2003;10(3):175-84. doi: 10.1002/oti.184.'}, {'pmid': '21667199', 'type': 'BACKGROUND', 'citation': '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': '22271197', 'type': 'BACKGROUND', 'citation': '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': '8195550', 'type': 'BACKGROUND', 'citation': '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': '16204405', 'type': 'BACKGROUND', 'citation': 'Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.'}]}, 'descriptionModule': {'briefSummary': "The goal is to pilot a parent-mediated intervention for feeding challenges in children with autism 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.", 'detailedDescription': "Recruitment of participants:\n\nFamilies will be recruited through local autism and therapy organizations, the Waisman Center Research Registry and existing studies of Autism Spectrum Disorder (ASD) and feeding. In addition, a targeted effort will be made to recruit a sample representative of the larger Madison community. A total of 50 families who have a child with a diagnosis of ASD (ages 2-7 years) and parent reported feeding problems will be recruited. Each child will be screened for eligibility based on the BAMBIC, STEP-CHILD, and a 10-item screening questionnaire developed for the study. The age range was selected to reliably confirm the ASD diagnosis, high parental involvement in feeding, and capture a small developmental range with a high prevalence of disordered feeding patterns. The diagnosis of ASD will be confirmed based on gold-standard assessment procedures: the ADOS and clinical impression under the supervision of a licensed clinical psychologist. The parent who assumes the primary role of feeding the child will be asked to participate with the child in the study. All individuals will be informed that they may withdraw participation at any time.\n\nProcedures:\n\nFifty families with a child with ASD will be asked to participate in 24 parent-mediated feeding intervention visits over approximately six-months. In addition, parents will be asked to participate in 6 to 8 parent training sessions in their home or by phone. Enrollment with two groups of families will be staggered to allow for any further adaptation and refinement of the protocol based on feedback from enrolled families.\n\nAll families will be asked to participate in an initial intake session that will include an overview of the intervention program, assessment of the intervention targets, parent interview, observation/videotape of a family mealtime, and complete standardized questionnaires on specific variables (e.g., developmental level, autism severity and sensory processing) that can influence feeding behaviors to further describe the population and explore potential confounding variables. The assessments and mealtime observation will assist in determining the child's current feeding challenges and targeted goals. Both parent and child will be asked to participate in a video-taped mealtime and free play time during a laboratory session at pre and post-intervention time points. During the laboratory session, both parent and child will be asked to wear a heart rate activity monitor that attached to their chest via a harness and an electrodermal skin conductance wrist band to allow for wireless physiological data collection. In addition, parents and children will also be requested to wear the heart rate activity monitor two times in their home environment during family mealtime. Hair samples will be taken from both the parent and the child to assess recent stress levels. Parents will collaborate in Goal Attainment Scaling to allow for a pre- and post-test comparison of child specific goals. In addition, feeding assessments as well as a parent stress measure, heart rate variability, and hair cortisol measurement will be used for a pre- and post-test comparison. Parents will participate in brief structured interviews before, one time during, and immediately following completion of the program to provide feedback on the intervention.\n\nIntervention:\n\n1. Parents will attend 8 group sessions that will be clustered in the first three quarters of the program focused on topics related to feeding challenges (e.g. goal setting, feeding development, parent-child interactions, sensory processing, behavior management, nutrition, the gastrointestinal system, and family mealtimes). Education sessions will be facilitated by the principal investigator and research team members.\n2. Parents will receive 6-10 individual sessions with a feeding interventionist that will support targeted goal setting, problem solving and individual coaching and feedback through video review of parent-led intervention.\n3. Parent-child dyads will receive 24 weekly sessions in the home that demonstrate modeling of intervention strategies and provide direct feedback of parent-led intervention. Parent satisfaction and burden will be assessed after each weekly session using a brief Likert scale questionnaire.\n4. Parents will be asked to commit 10-15 hours per week in the home setting to directly support targeted feeding goals and related challenges such as sensory processing that may be a barrier to successful eating. Two trained individuals with experience working with children with ASD will be hired to support facilitation of the parent-mediated intervention. Several steps will be taken to train and supervise the interventionists. In addition, a minimum of 20% of their interactions will be video-taped reviewed by the principal investigator to monitor treatment fidelity.\n\nAnalysis:\n\nDescriptive statistics will be used to describe the family and child characteristics as well as family satisfaction. Interview data from the parents will be audio recorded, transcribed verbatim and imported into Nvivo for data management and analysis support to inform future adaptations of the intervention program as well as beginning to unravel who the program may be most effective for and why. An analysis of variance (ANOVA) will be used to assess the pre- and post-intervention differences of the key variables of interest."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child with a confirmed diagnosis of ASD (ages 2-7 years)\n* Parent reported feeding problems\n* English Speaking\n\nExclusion Criteria:\n\n* Any conditions co-morbid with ASD (e.g., fragile X)\n* Significant visual, hearing or physical impairments\n* Children who receive any non-oral nutritional supplementation (e.g. gastrostomy tubes)'}, 'identificationModule': {'nctId': 'NCT03071120', 'briefTitle': 'Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges', 'orgStudyIdInfo': {'id': '2016-1428'}, 'secondaryIdInfos': [{'id': 'A176000', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'EDUC\\KINESIOLOGY\\KINESIO', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parent-Mediated Intervention with ASD', 'description': 'In-home intervention (1-2x/week) will occur with families with children with ASD, including direct intervention, parent coaching, and parent training.', 'interventionNames': ['Behavioral: Parent-Mediated Intervention']}], 'interventions': [{'name': 'Parent-Mediated Intervention', 'type': 'BEHAVIORAL', 'description': 'Children with ASD will participate in a 6-month parent-mediated intervention that will include direct intervention and parent education.', 'armGroupLabels': ['Parent-Mediated Intervention with ASD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Waisman Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Karla K Ausderau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}