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Parent Video Feedback Intervention Study

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ClinicalTrials.gov Identifier: NCT03397719
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Parent-Child Relations Behavioral: Treatment Condition Behavioral: Control Group Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parent Feedback Intervention Study: A Randomized Controlled Trial
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : October 13, 2022
Estimated Study Completion Date : October 13, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group
This group will receive treatment as usual. Each participant will receive three hours of in-vivo parent coaching per week for 6 months.
Behavioral: Control Group
This group will receive in-vivo parent coaching three hours per week.

Experimental: Treatment Condition
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.
Behavioral: Treatment Condition
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.




Primary Outcome Measures :
  1. Brief Observation of Social Communication Change (BOSCC) [ Time Frame: pre, months 1-6, and follow-up (12 months) ]
    This is a brief, play-based assessment that aims to measure short-term changes in social communication.


Secondary Outcome Measures :
  1. Autism Diagnostic Observation Schedule-2 (ADOS-2) [ Time Frame: Pre, post (6 months), follow-up (12 months) ]
    This is a semi-structured play-based interaction that assesses for symptoms associated with an Autism Spectrum Disorder (ASD).


Other Outcome Measures:
  1. Parent Strategies Rating [ Time Frame: pre, months 1-6, and follow-up (12 months) ]
    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.

  2. Mullen Scales of Early Learning (MSEL) [ Time Frame: Pre, post (6 months), follow-up (12 months) ]
    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.

  3. Vineland Adaptive Behavior Scales, Third Edition (VABS-III) [ Time Frame: Pre, post (6 months), follow-up (12 months) ]
    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.



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Ages Eligible for Study:   1 Year to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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 ClinicalTrials.gov identifier (NCT number): NCT03397719


Contacts
Contact: So Hyun Kim, Ph.D. 914-997-5269 sok2015@med.cornell.edu
Contact: Bethany A Vibert, Psy.D. 914-997-4828 bav2006@med.cornell.edu

Locations
United States, New York
Weill Cornell Medicine Center for Autism and the Developing Brain Recruiting
White Plains, New York, United States, 07302
Contact: So Hyun Kim, Ph.D.    914-997-5269    sok2015@med.cornell.edu   
Contact: Bethany Vibert, Psy.D.    914-997-4828    bav2006@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: So Hyun Kim, Ph.D. Weill Cornell Medicine

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03397719     History of Changes
Other Study ID Numbers: 1707018416
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We are undecided.

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

Keywords provided by Weill Medical College of Cornell University:
Autism Spectrum Disorder
Early Intervention
Parent-Mediated Intervention

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