Parent Video Feedback Intervention Study

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Completed
CT.gov ID
NCT03397719
Collaborator
(none)
20
1
2
48.4
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Treatment Condition
  • Behavioral: Control Group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 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 :
Oct 13, 2017
Actual Primary Completion Date :
Oct 25, 2021
Actual Study Completion Date :
Oct 25, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Brief Observation of Social Communication Change (BOSCC) [Baseline, 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. Scores range from 0 to 60 with higher scores indicating more ASD symptoms.

Secondary Outcome Measures

  1. Change in Autism Diagnostic Observation Schedule-2 (ADOS-2) [Baseline, 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). Total calibrated severity score ranges from 0 to 10, with higher scores indicating more ASD symptoms.

  2. Change in Beck Depression Inventory [Baseline, post (6 months)]

    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.

  3. Change in Beck Anxiety Inventory [Baseline, post (6 months)]

    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.

  4. Change in Parent Stress Index [Baseline, post (6 months)]

    Evaluate the magnitude of stress in the parent. Percentile scores range from 0 to 100, with higher scores indicating greater parenting stress.

  5. Change in Behavior Rating Inventory of Executive Function-Preschool Version [Baseline, post (6 months)]

    Standardized rating scale designed to specifically measure the range of behavioral manifestations of executive function in preschool-aged children

Other Outcome Measures

  1. Change in Parent Strategies Rating [Baseline, 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.Scores range from 19 to 100. Higher scores indicate effective and appropriate use of strategies taught in NDBI.

  2. Change in Mullen Scales of Early Learning (MSEL) [Baseline, 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. Early Learning Composite Score ranges from 49 to 155, with higher scores indicating higher developmental and cognitive functioning.

  3. Change in Vineland Adaptive Behavior Scales, Third Edition (VABS-III) [Baseline, 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. Adaptive Behavior Composite Score ranges from 20 to 140, with higher scores indicating higher adaptive functioning.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weill Cornell Medicine Center for Autism and the Developing Brain White Plains New York United States 07302

Sponsors and Collaborators

  • Weill Medical College of Cornell University

Investigators

  • Principal Investigator: So Hyun Kim, Ph.D., Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT03397719
Other Study ID Numbers:
  • 1707018416
First Posted:
Jan 12, 2018
Last Update Posted:
Oct 29, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 29, 2021