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

NCT03071120 | Completed

• 3 other identifiers: 2016-1428A176000EDUC\KINESIOLOGY\KINESIO
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parent-Child Relations; Meals; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• Change in Brief Autism Mealtime Behavior Inventory (BAMBIC)

  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.

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

• 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 Behavioral Pediatric Feeding Assessment Scale (BPFAS)

  Parent report measure designed to identify mealtime 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.

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

Secondary Outcomes (3)

• Beck Depression Inventory-II (BDI)

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

• Parenting Stress Index-Short Form (PSI-SF)

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

• 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)

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)

Waisman Center

Madison, Wisconsin, 53705, United States

Location

Related Publications (30)

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  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

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• 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.

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• 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.

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• 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.

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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: February 15, 2017
• First Posted: March 6, 2017
• Study Start: February 3, 2017
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)