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Effectiveness of Modified Interaction Guidance as an Intervention Tool for Caregivers and Their Child With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03972254
Recruitment Status : Not yet recruiting
First Posted : June 3, 2019
Last Update Posted : August 8, 2019
Information provided by (Responsible Party):
University of Manitoba

Brief Summary:
The purpose of this mixed methods single subject study is to test the Modified Interaction Guidance (MIG) as an intervention to improve attachment for children with autism and their primary caregiver.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Modified Interaction Guidance Not Applicable

Detailed Description:

This study aims to answer the following research questions and hypotheses:

  1. Does the use of MIG with a child with autism, result in changes in attachment such as alterations in sensitivity and attunement, in a child-caregiver relationship? H1: A change in the rating on the GAS will demonstrate effectiveness of goal setting as a means of detecting changes in dyad relationship goals, as well as result in increased attunement and parental sensitivity as evidence by maintained or improved score in the AMBIANCE, PICCOLO and SAIAS following a 2-month period.
  2. Do caregivers feel more competent in their caregiving skills through the use of MIG? H2: Caregivers will demonstrate increased feelings of competency through the use of MIG as evidenced by scores on the Parenting Sense of Competency Scale.
  3. Do caregivers feel less stress in their role as a caregiver through the use of MIG? H3: Caregivers will demonstrate less feelings of stress through the use of the MIG as evidenced by scores on the Parent Stress Index.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study is an explanatory sequential mixed methods study in which the quantitative complement (concurrent multiple baseline single case study) will be completed first, followed by qualitative interviews that build on and further explain the quantitative data.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Modified Interaction Guidance as an Intervention Tool for Caregivers and Their Child With Autism
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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.

Primary Outcome Measures :
  1. Parenting Interactions with Children Checklist of Observations Linked to Outcomes (PICCOLO) [ Time Frame: 11 weeks ]
    Serves as an observational tool to determine parental abilities in four specific domains; Affection, Responsiveness, Encouragement and Teaching.

Secondary Outcome Measures :
  1. Atypical Maternal Behaviour Instrument for Assessment and Classification (AMBIANCE) [ Time Frame: Week 1, week 7 and week 11. ]
    It is an observational tool used to measure and ultimately assess the quality of parental interaction with their infant/child. It looks at atypical parental behaviours that are dysfunctional.

  2. Sensoriaffective Interactional Attunement Scale (SAIAS) [ Time Frame: Week 1, week 7 and week 11. ]
    Assesses caregiver-child interactions and to target interventions to support . These items include, use of facial expressions, use of gesture, use of touch, use of position, use of movement, use of sound, use of language, use of pacing, and following a child's actions/intent. The items are scored on a 1-4 range. 1= rarely/very mild and a 4= always/severe on both underuse and overuse subsections.improvements in child, caregiver, and dyadic social-emotional functioning.

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Months to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 11-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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03972254

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Contact: Megan Land McCarthy, Bsc OT 204-293-7043
Contact: Leanne Leclair, PhD OT 204-977-5631

Sponsors and Collaborators
University of Manitoba
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Principal Investigator: Megan Land McCarthy, Bsc OT University of Manitoba

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Responsible Party: University of Manitoba Identifier: NCT03972254     History of Changes
Other Study ID Numbers: H2019:105
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Manitoba:
Modified Interaction Guidance

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders