- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03972254
Feasibility of Using Telepractice to Provide Modified Interaction Guidance.
Feasibility of Using Telepractice to Provide Modified Interaction Guidance as an Intervention Tool for Caregivers and Their Child With Autism
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3E0T6
- College of Rehabilitation Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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: Intervention
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting Interactions with Children Checklist of Observations Linked to Outcomes (PICCOLO)
Time Frame: 4 weeks
|
Serves as an observational tool to determine parental abilities in four specific domains; Affection, Responsiveness, Encouragement and Teaching.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goal Attainment Scale (GAS)
Time Frame: Immediately right before and after the Intervention
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Used to evaluate client specific goals.
When goals are established by the client, the goals are then evaluated and measured by client specific criterion.
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Immediately right before and after the Intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent Sense of Competency (PSOC)
Time Frame: Baseline and 2 weeks post intervention.
|
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.
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Baseline and 2 weeks post intervention.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Megan Land McCarthy, Bsc OT, University of Manitoba
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2019:105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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