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

May 20, 2024 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fifty families with a child with Autism spectrum disorder (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.

All 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.

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 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.
  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

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
        • La Trobe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. 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)
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. 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
Time Frame: Pre/Post measure through study completion, an average of 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Caregiver Involvement Scale Score
Time Frame: Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months)
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.
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
Time Frame: Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months)
Measures the amount of effort parents are applying to help their child complete daily activities. . 34-items about parental effort are scored on a 5-point likert scale from 1 (none) to 5 (too much to participate) for a total score of 34-170 where higher scores indicate increased parent effort.
Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Karla K Ausderau, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2023

Primary Completion (Actual)

May 8, 2024

Study Completion (Actual)

May 8, 2024

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-1428 Australia
  • A176000 (Other Identifier: UW Madison)
  • EDUC\KINESIOLOGY\KINESIO (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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