Autism Spectrum DisorderNCT03972254
Feasibility of Using Telepractice to Provide Modified Interaction Guidance.
A study testing Modified Interaction Guidance in people with Autism Spectrum Disorder, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 10 months to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Modified Interaction Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 months to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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?
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Using Telepractice to Provide Modified Interaction Guidance as an Intervention Tool for Caregivers and Their Child With Autism
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Modified Interaction Guidance
- Keywords
- Modified Interaction Guidance
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Interaction GuidanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Modified Interaction Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately right before and after the Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Nov 2020
- Primary completion1 Mar 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a mixed methods feasibility study using a single-subject research design and qualitative description.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Land McCarthy, Bsc OT, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972254
- Sponsor's protocol ID
- H2019:105
- Status last verified
- Dec 2021
- First submitted
- 13 May 2019
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using Telepractice to Provide Modified Interaction Guidance as an Intervention Tool for Caregivers and Their Child With Autism
- ClinicalTrials.gov ID
- NCT03972254
- Acronym / sponsor ID
- H2019:105
- Conditions
- Autism Spectrum Disorder
- Keywords
- Modified Interaction Guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a mixed methods feasibility study using a single-subject research design and qualitative description.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Modified Interaction GuidanceCaregivers 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. |
Who may qualify
- Ages
- 10 months to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Interaction GuidanceThe 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. | Behavioural | Intervention |
Primary outcome
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.
1 secondary outcome
Goal Attainment Scale (GAS)
Time frame: Immediately right before and after the Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Land McCarthy, Bsc OT principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Interaction Guidance in people with Autism Spectrum Disorder, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Interactions with Children Checklist of Observations Linked to Outcomes (PICCOLO) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.