Skip to main content
OpenTrials
Completed

NCT Number: NCT03397719

Parent Video Feedback Intervention Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Parent-Child Relations

Age range

1 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine Center for Autism and the Developing Brain

White Plains, New York, 07302, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Treatment Condition

Behavioral

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.

Control Group

Behavioral

This group will receive in-vivo parent coaching three hours per week.

Primary outcomes

  1. Change in Brief Observation of Social Communication Change (BOSCC)

    Time frame: 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 outcomes

  1. Change in Autism Diagnostic Observation Schedule-2 (ADOS-2)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, post (6 months)

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

Other outcomes

  1. Change in Parent Strategies Rating

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Parent Feedback Intervention Study: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2018
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.