ClinicalTrials.gg
CompletedNCT03972254Updated Jan 12, 2022

Feasibility of Using Telepractice to Provide Modified Interaction Guidance.

An interventional study of Modified Interaction Guidance in Autism Spectrum Disorder, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 10 Months to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-12.

Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
10 Months to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • Modified Interaction Guidance
03

In context

Autism Spectrum Disorder

1,755 studies on the registry are indexed under Autism Spectrum Disorder; 507 are open to participants now.

This study's enrollment of 8 is below the median of 52 across 1,391 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

University of Manitoba is the lead sponsor of 554 studies on the registry; 88 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Months to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • 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.

    Behavioral: Modified Interaction Guidance

Interventions

  • BehavioralModified 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

Secondary outcomes

  1. 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.

    Time frame: Immediately right before and after the Intervention

Other outcomes

  1. 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.

    Time frame: Baseline and 2 weeks post intervention.

07

Study locations

1 site
  • College of Rehabilitation Sciences
    Winnipeg, Manitoba R3E0T6, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2020 to primary completion in Mar 2021, 4 months.

Of 801 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 4 months is below that.

Counting every sponsor, half of 825 studies reached it within 25 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2019
First posted
Jun 3, 2019
StartActual
Nov 1, 2020
Primary completionActual
Mar 1, 2021
CompletionActual
Dec 1, 2021
Last update
Jan 12, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03972254
Responsible party
Sponsor
First posted
Jun 3, 2019
Start date
Nov 1, 2020
Primary completion
Mar 1, 2021
Completion
Dec 1, 2021
Last update
Jan 12, 2022

Study contacts

Megan Land McCarthy, Bsc OT
principal investigator · University of Manitoba

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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