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

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ClinicalTrials.gov Identifier: NCT03071120
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The goal is to pilot a parent-mediated intervention for feeding challenges in children with autism building on our 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.

Condition or disease Intervention/treatment Phase
Parent-Child Relations Meals Autism Spectrum Disorder Behavioral: Parent-Mediated Intervention Not Applicable

Detailed Description:

Recruitment of participants:

Families 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 seventeen 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.

Intervention:

  1. 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.
  2. 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.
  3. Parent-child dyads will receive 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.
  4. 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.

Analysis:

Descriptive 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Intervention Model: Single Group Assignment
Intervention Model Description: One group, pre, post-test
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges
Actual Study Start Date : February 3, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Parent-Mediated Intervention with ASD Behavioral: Parent-Mediated Intervention
Children with ASD will participate in a 6-month parent-mediated intervention that will include direct intervention and parent education.



Primary Outcome Measures :
  1. Change in Brief Autism Mealtime Behavior Inventory (BAMBIC) [ Time Frame: Pre/post measure through study completion, an average of 6 months ]
    Parent report 18 item inventory that uses a Likert scale to report frequency of mealtime problem behaviors in children

  2. Change in Sensory Experiences Questionnaire (SEQ 3.0) [ Time Frame: Pre/post measure through study completion, an average of 6 months ]
    caregiver report instrument designed to characterize sensory features in children ages 2-12 years with ASD

  3. Change in Behavioral Pediatric Feeding Assessment Scale (BPFAS) [ Time Frame: Pre/post measure through study completion, an average of 6 months ]
    Parent report measure designed to identify mealtime behaviors

  4. Change in Goal Attainment Scaling (GAS). [ Time Frame: Pre/Post measure through study completion, an average of 6 months ]
    Assesses the effectiveness of psycho-social interventions in the community setting in ASD.


Secondary Outcome Measures :
  1. Beck Depression Inventory-II (BDI) [ Time Frame: Pre/post measure through study completion, an average of 6 months ]
    Used to assess parent depression and stress.

  2. Parenting Stress Index-Short Form (PSI-SF) [ Time Frame: Pre/post measure through study completion, an average of 6 months ]
    Used to assess parent depression and stress.



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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071120


Contacts
Contact: Karla K Ausderau, Ph.D (310) 428-8398 kausderau@wisc.edu
Contact: Sigan Hartley, Ph. D

Locations
United States, Wisconsin
Waisman Center Recruiting
Madison, Wisconsin, United States, 53705
Contact: Karla Ausderau, PhD, OTD    310-428-8398    kausderau@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison

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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03071120     History of Changes
Other Study ID Numbers: 2016-1428
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders