Back to resultsFeasibility of Using Telepractice to Provide Modified Interaction Guidance.
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Modified Interaction Guidance
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Modified Interaction Guidance
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of autism spectrum disorder
- Child between the ages of 24-60 months
- First born child
- No physical or medical conditions that affect the child's ability to participate in the activities that are part of the intervention process
- Ability to follow simple verbal directions in English
- No current plan to initiate any treatment alternatives during the study period
- Willingness to participate in a -week intervention with a frequency of once a week
- Adults are primary caregiver
- Under age of 35
- Speak English
- Minimum grade 5 schooling
- Access to a computer and broadband wired or wireless (3G or 4G/LTE) internet connection?
Exclusion Criteria:
- Participants (both child and adult) will be excluded from the present study if they were deemed low functioning
- child is not the first-born child
- child already receiving ABA treatment
- parents have a history of mental illness
Sites / Locations
- College of Rehabilitation Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Caregivers and their child will interact for 10 minutes while being observed and videotaped. Psychoeducation will be provided and goal setting will occur to ensure dyad specific relationship gains are made.
Outcomes
Primary Outcome Measures
Parenting Interactions with Children Checklist of Observations Linked to Outcomes (PICCOLO)
Serves as an observational tool to determine parental abilities in four specific domains; Affection, Responsiveness, Encouragement and Teaching.
Secondary Outcome Measures
Goal Attainment Scale (GAS)
Used to evaluate client specific goals. When goals are established by the client, the goals are then evaluated and measured by client specific criterion.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03972254
Brief Title
Feasibility of Using Telepractice to Provide Modified Interaction Guidance.
Official Title
Feasibility of Using Telepractice to Provide Modified Interaction Guidance as an Intervention Tool for Caregivers and Their Child With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
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 purpose of this study is to determine the feasibility of using telepractice to provide Modified Interaction Guidance (MIG) to caregivers and their child with autism. MIG as an intervention to improve attachment for children with autism and their primary caregiver.
Detailed Description
The process objectives target focus on1) recruitment, 2) retention, 3) engagement with tools, 4) time demand on dyads, and 5) eligibility criteria.
The resource assessment objectives include: 1) equipment and internet accessibility 2) communication methods, and 3) timelines.
The management assessment objectives address: 1) ethical standards, 2) researcher qualifications and 3) data storage and collection.
Finally, when looking at the scientific assessment, the objectives relate to: 1) Is use of a concurrent multiple baseline single-subject design feasible with this population? 2)capturing dyad needs, 3) burden levels, and 4) safety protocols.
This study will evaluate the above listed dimensions of feasibility using a embedded mixed methods approach that incorporates both a single-subject design and qualitative data gathered throughout the research process and post intervention individual interviews.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Modified Interaction Guidance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is a mixed methods feasibility study using a single-subject research design and qualitative description.
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Caregivers and their child will interact for 10 minutes while being observed and videotaped. Psychoeducation will be provided and goal setting will occur to ensure dyad specific relationship gains are made.
Intervention Type
Behavioral
Intervention Name(s)
Modified Interaction Guidance
Intervention Description
The main steps in the procedure are to have the family identify the primary concern they are facing, highlight the strengths that the family already has in place and expand on those strengths, convey/impart caregiving and societal norms, and offer other perspectives (McDonough, 2004). The goal of this therapy is to engage the family to take an active role in the construction of their overall treatment. The individualized treatment approach focuses and builds on existing strengths.
Primary Outcome Measure Information:
Title
Parenting Interactions with Children Checklist of Observations Linked to Outcomes (PICCOLO)
Description
Serves as an observational tool to determine parental abilities in four specific domains; Affection, Responsiveness, Encouragement and Teaching.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Goal Attainment Scale (GAS)
Description
Used to evaluate client specific goals. When goals are established by the client, the goals are then evaluated and measured by client specific criterion.
Time Frame
Immediately right before and after the Intervention
Other Pre-specified Outcome Measures:
Title
Parent Sense of Competency (PSOC)
Description
Measures parent's feelings of self-esteem and satisfaction of the ability in a parenting role. The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree". A higher score indicates a higher parenting sense of competency.
Time Frame
Baseline and 2 weeks post intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of autism spectrum disorder
Child between the ages of 24-60 months
First born child
No physical or medical conditions that affect the child's ability to participate in the activities that are part of the intervention process
Ability to follow simple verbal directions in English
No current plan to initiate any treatment alternatives during the study period
Willingness to participate in a -week intervention with a frequency of once a week
Adults are primary caregiver
Under age of 35
Speak English
Minimum grade 5 schooling
Access to a computer and broadband wired or wireless (3G or 4G/LTE) internet connection?
Exclusion Criteria:
Participants (both child and adult) will be excluded from the present study if they were deemed low functioning
child is not the first-born child
child already receiving ABA treatment
parents have a history of mental illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Land McCarthy, Bsc OT
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Rehabilitation Sciences
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E0T6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility of Using Telepractice to Provide Modified Interaction Guidance.
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