Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges, Australia Cohort
Primary Purpose
Parent-Child Relations, Meals, Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Parent-Mediated Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Parent-Child Relations
Eligibility 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)
Sites / Locations
- La Trobe UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Parent-Mediated Intervention with ASD
Arm Description
In-home intervention (1-2x/week) will occur with families with children with ASD, including direct intervention, parent coaching, and parent training.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Change in the Caregiver Involvement Scale Score
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.
Change in Parent effort scale
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.
Full Information
NCT ID
NCT05852548
First Posted
April 28, 2023
Last Updated
July 12, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT05852548
Brief Title
Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges, Australia Cohort
Official Title
Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges, Australia Cohort
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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:
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.
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parent-Child Relations, Meals, Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group, pre, post-test
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parent-Mediated Intervention with ASD
Arm Type
Experimental
Arm Description
In-home intervention (1-2x/week) will occur with families with children with ASD, including direct intervention, parent coaching, and parent training.
Intervention Type
Behavioral
Intervention Name(s)
Parent-Mediated Intervention
Intervention Description
Children with ASD will participate in a 6-month parent-mediated intervention that will include direct intervention and parent education.
Primary Outcome Measure Information:
Title
Change in Sensory Experiences Questionnaire (SEQ 3.0)
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.
Time Frame
Pre/post measure through study completion, an average of 6 months
Title
Change in Goal Attainment Scaling (GAS)
Description
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.
Time Frame
Pre/Post measure through study completion, an average of 6 months
Title
Change in Feeding and Eating in AutiSm Together Questionnaire
Description
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.
Time Frame
Pre/Post measure through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Change in the Caregiver Involvement Scale Score
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.
Time Frame
Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months)
Title
Change in Parent effort scale
Description
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.
Time Frame
Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karla K Ausderau, PhD
Phone
(310) 428-8398
Email
kausderau@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karla K Ausderau, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Trobe University
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Lane, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges, Australia Cohort
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