NCT03972254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 12, 2022

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

May 13, 2019

Last Update Submit

January 11, 2022

Conditions

Keywords

Modified Interaction Guidance

Outcome Measures

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.

    4 weeks

Secondary Outcomes (1)

  • Goal Attainment Scale (GAS)

    Immediately right before and after the Intervention

Other Outcomes (1)

  • Parent Sense of Competency (PSOC)

    Baseline and 2 weeks post intervention.

Study Arms (1)

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.

Behavioral: Modified Interaction Guidance

Interventions

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.

Intervention

Eligibility Criteria

Age10 Months - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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?

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Rehabilitation Sciences

Winnipeg, Manitoba, R3E0T6, Canada

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Megan Land McCarthy, Bsc OT

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study is a mixed methods feasibility study using a single-subject research design and qualitative description.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2019

First Posted

June 3, 2019

Study Start

November 1, 2020

Primary Completion

March 1, 2021

Study Completion

December 1, 2021

Last Updated

January 12, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations