Parent Video Feedback Intervention Study

Parent Feedback Intervention Study: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Parent-Child Relations; Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Control Group; Behavioral: Treatment Condition

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
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 07302
      • Weill Cornell Medicine Center for Autism and the Developing Brain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, months 1-6, and follow-up (12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, post (6 months), follow-up (12 months)
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.	Baseline, post (6 months)
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.	Baseline, post (6 months)
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.	Baseline, post (6 months)
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	Baseline, post (6 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Parent Strategies Rating	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.	Baseline, months 1-6, and follow-up (12 months)
Change in Mullen Scales of Early Learning (MSEL)	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.	Baseline, post (6 months), follow-up (12 months)
Change in Vineland Adaptive Behavior Scales, Third Edition (VABS-III)	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.	Baseline, post (6 months), follow-up (12 months)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2017
• Primary Completion (ACTUAL): October 25, 2021
• Study Completion (ACTUAL): October 25, 2021

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (ACTUAL): January 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Autism Spectrum Disorder; Early Intervention; Parent-Mediated Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 1707018416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are undecided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No