Parent Video Feedback Intervention Study

Autism Spectrum Disorder Clinical Trial

Official title:

Parent Feedback Intervention Study: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397719
• Other study ID #: 1707018416
• Status: Completed
• Phase: N/A
• Start date: October 13, 2017
• Est. completion date: October 25, 2021

Study information

• Verified date: October 2021
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 4 Years

Eligibility

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).

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Parent-Child Relations

Intervention

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

Locations

Country	Name	City	State
United States	Weill Cornell Medicine Center for Autism and the Developing Brain	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)