Parent Video Feedback Intervention Study
Primary Purpose
Autism Spectrum Disorder, Parent-Child Relations
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment Condition
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Early Intervention, Parent-Mediated Intervention
Eligibility Criteria
Inclusion Criteria:
- All children who will be enrolled into the early intervention (EI) classroom at the Center for Autism and the Developing Brain (CADB) will be invited to participate in the study.
Exclusion Criteria:
- We do not have any exclusionary criteria as long as the children meet the inclusion criteria (families with children with ASD between 1-4 years who will be enrolling in the CADB early intervention classroom).
Sites / Locations
- Weill Cornell Medicine Center for Autism and the Developing Brain
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Treatment Condition
Arm Description
This group will receive treatment as usual. Each participant will receive three hours of in-vivo parent coaching per week for 6 months.
This group will receive an additional component which will involve videotaping parent/child interactions at home for thirty minutes a week. Each week, the therapist will select sections of the video to review with the parent during one of the parent coaching sessions.
Outcomes
Primary Outcome Measures
Change in Brief Observation of Social Communication Change (BOSCC)
This is a brief, play-based assessment that aims to measure short-term changes in social communication. Scores range from 0 to 60 with higher scores indicating more ASD symptoms.
Secondary Outcome Measures
Change in Autism Diagnostic Observation Schedule-2 (ADOS-2)
This is a semi-structured play-based interaction that assesses for symptoms associated with an Autism Spectrum Disorder (ASD). Total calibrated severity score ranges from 0 to 10, with higher scores indicating more ASD symptoms.
Change in Beck Depression Inventory
Self-report rating inventory that measures characteristic attitudes and symptoms of depression. Scores range from 0 to 63, with higher scores indicating higher degrees of depression.
Change in Beck Anxiety Inventory
Self-report inventory used to assess anxiety levels in adults and adolescents. Scores range from 0 to 63, with higher scores indicating higher degrees of anxiety.
Change in Parent Stress Index
Evaluate the magnitude of stress in the parent. Percentile scores range from 0 to 100, with higher scores indicating greater parenting stress.
Change in Behavior Rating Inventory of Executive Function-Preschool Version
Standardized rating scale designed to specifically measure the range of behavioral manifestations of executive function in preschool-aged children
Full Information
NCT ID
NCT03397719
First Posted
December 13, 2017
Last Updated
October 27, 2021
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT03397719
Brief Title
Parent Video Feedback Intervention Study
Official Title
Parent Feedback Intervention Study: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
October 25, 2021 (Actual)
Study Completion Date
October 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to use a randomized controlled trial to test the effectiveness of parent coaching sessions using video-based feedback, compared to the sessions without the use of video-based feedback on parent strategy use.
Detailed Description
This study is a randomized controlled trial of video-based feedback interventions for the parents of young children with autism spectrum disorder (ASD). In the beginning of the study, each participant will be randomized to the video-based feedback condition (treatment condition) or standard care procedure (control condition). All participants will be asked to implement the strategies taught during the sessions in the home environment (e.g., following the child's lead, sitting face-to-face). Participants randomized into the video-based feedback condition (treatment condition) will be asked to video-tape their interactions with their children (maximum 30 mins/week at home during free play, book reading, bath or meal time routines). The therapist then will review the tapes and then use the recorded sessions to give feedback on the parents' use of strategies in addition to providing in-vivo feedback based on the live interactions during the sessions. For parents whose children are randomized into the standard care condition, the families will receive coaching based on in-vivo sessions as described above. For all participants, a battery of assessment (diagnostic, developmental testing), will be administered at the beginning of the study participation, in the mid-point at 3 months, at the end of their 6-month participation of treatment sessions, and then at the follow-up period, 6 months after the end of their participation of the treatment sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Parent-Child Relations
Keywords
Autism Spectrum Disorder, Early Intervention, Parent-Mediated Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
This group will receive treatment as usual. Each participant will receive three hours of in-vivo parent coaching per week for 6 months.
Arm Title
Treatment Condition
Arm Type
Experimental
Arm Description
This group will receive an additional component which will involve videotaping parent/child interactions at home for thirty minutes a week. Each week, the therapist will select sections of the video to review with the parent during one of the parent coaching sessions.
Intervention Type
Behavioral
Intervention Name(s)
Treatment Condition
Intervention Description
This group will receive three hours of parent coaching per week, one hour per week will involve feedback on parent usage of coached strategies based on parent recorded interactions with their children.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
This group will receive in-vivo parent coaching three hours per week.
Primary Outcome Measure Information:
Title
Change in Brief Observation of Social Communication Change (BOSCC)
Description
This is a brief, play-based assessment that aims to measure short-term changes in social communication. Scores range from 0 to 60 with higher scores indicating more ASD symptoms.
Time Frame
Baseline, months 1-6, and follow-up (12 months)
Secondary Outcome Measure Information:
Title
Change in Autism Diagnostic Observation Schedule-2 (ADOS-2)
Description
This is a semi-structured play-based interaction that assesses for symptoms associated with an Autism Spectrum Disorder (ASD). Total calibrated severity score ranges from 0 to 10, with higher scores indicating more ASD symptoms.
Time Frame
Baseline, post (6 months), follow-up (12 months)
Title
Change in Beck Depression Inventory
Description
Self-report rating inventory that measures characteristic attitudes and symptoms of depression. Scores range from 0 to 63, with higher scores indicating higher degrees of depression.
Time Frame
Baseline, post (6 months)
Title
Change in Beck Anxiety Inventory
Description
Self-report inventory used to assess anxiety levels in adults and adolescents. Scores range from 0 to 63, with higher scores indicating higher degrees of anxiety.
Time Frame
Baseline, post (6 months)
Title
Change in Parent Stress Index
Description
Evaluate the magnitude of stress in the parent. Percentile scores range from 0 to 100, with higher scores indicating greater parenting stress.
Time Frame
Baseline, post (6 months)
Title
Change in Behavior Rating Inventory of Executive Function-Preschool Version
Description
Standardized rating scale designed to specifically measure the range of behavioral manifestations of executive function in preschool-aged children
Time Frame
Baseline, post (6 months)
Other Pre-specified Outcome Measures:
Title
Change in Parent Strategies Rating
Description
This is a rating scale that is currently under development. It will be used to rate the parents' utilization of the strategies they are being taught throughout the intervention.Scores range from 19 to 100. Higher scores indicate effective and appropriate use of strategies taught in NDBI.
Time Frame
Baseline, months 1-6, and follow-up (12 months)
Title
Change in Mullen Scales of Early Learning (MSEL)
Description
This is a structured cognitive assessment which measures a child's abilities in visual reception, fine motor, expressive language, and receptive language. It will be used to assess cognitive functioning. Early Learning Composite Score ranges from 49 to 155, with higher scores indicating higher developmental and cognitive functioning.
Time Frame
Baseline, post (6 months), follow-up (12 months)
Title
Change in Vineland Adaptive Behavior Scales, Third Edition (VABS-III)
Description
This is a structured interview that a trained assessor administers to a parent in order to assess adaptive functioning across a variety of domains including communication, play and leisure, and social domains. Adaptive Behavior Composite Score ranges from 20 to 140, with higher scores indicating higher adaptive functioning.
Time Frame
Baseline, post (6 months), follow-up (12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All children who will be enrolled into the early intervention (EI) classroom at the Center for Autism and the Developing Brain (CADB) will be invited to participate in the study.
Exclusion Criteria:
We do not have any exclusionary criteria as long as the children meet the inclusion criteria (families with children with ASD between 1-4 years who will be enrolling in the CADB early intervention classroom).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
So Hyun Kim, Ph.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine Center for Autism and the Developing Brain
City
White Plains
State/Province
New York
ZIP/Postal Code
07302
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
We are undecided.
Citations:
PubMed Identifier
34925094
Citation
Klein CB, Swain DM, Vibert B, Clark-Whitney E, Lemelman AR, Giordano JA, Winter J, Kim SH. Implementation of Video Feedback Within a Community Based Naturalistic Developmental Behavioral Intervention Program for Toddlers With ASD: Pilot Study. Front Psychiatry. 2021 Dec 2;12:763367. doi: 10.3389/fpsyt.2021.763367. eCollection 2021.
Results Reference
derived
Learn more about this trial
Parent Video Feedback Intervention Study
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