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Clinical Trials/NCT03972254
NCT03972254CompletedNot Applicable

Feasibility of Using Telepractice to Provide Modified Interaction Guidance as an Intervention Tool for Caregivers and Their Child With Autism

University of Manitoba1 site in 1 country8 target enrollmentStarted: November 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
8
Locations
1
Primary Endpoint
Parenting Interactions with Children Checklist of Observations Linked to Outcomes (PICCOLO)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
10 Months to 35 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Intervention

Experimental

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: Modified Interaction Guidance (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Goal Attainment Scale (GAS)(Immediately right before and after the Intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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