Feasibility of Using Telepractice to Provide Modified Interaction Guidance.

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972254
• Other study ID #: H2019:105
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Months to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• Modified Interaction Guidance
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.

Locations

Country	Name	City	State
Canada	College of Rehabilitation Sciences	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parent Sense of Competency (PSOC)	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.	Baseline and 2 weeks post intervention.
Primary	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.	4 weeks
Secondary	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.	Immediately right before and after the Intervention