Clinical trial NCT03972254: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Modified Interaction Guidance
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 8
Sex: ALL
Minimum age (years): 10
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a mixed methods feasibility study using a single-subject research design and qualitative description.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of autism spectrum disorder
2. Child between the ages of 24-60 months
3. First born child
4. No physical or medical conditions that affect the child's ability to participate in the activities that are part of the intervention process
5. Ability to follow simple verbal directions in English
6. No current plan to initiate any treatment alternatives during the study period
7. Willingness to participate in a -week intervention with a frequency of once a week
8. Adults are primary caregiver
9. Under age of 35
10. Speak English
11. Minimum grade 5 schooling
12. 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

Primary outcomes:
measure: Parenting Interactions with Children Checklist of Observations Linked to Outcomes (PICCOLO)
timeFrame: 4 weeks
Secondary outcomes:
measure: Goal Attainment Scale (GAS)
timeFrame: Immediately right before and after the Intervention
Other outcomes:
measure: Parent Sense of Competency (PSOC)
timeFrame: Baseline and 2 weeks post intervention.
Locations:
city: Winnipeg
country: Canada
facility: College of Rehabilitation Sciences
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Megan Land McCarthy, Bsc OT
role: PRINCIPAL_INVESTIGATOR
References: