NCT03397719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2021

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

4 years

First QC Date

December 13, 2017

Last Update Submit

October 27, 2021

Conditions

Autism Spectrum DisorderParent-Child Relations

Keywords

Autism Spectrum DisorderEarly InterventionParent-Mediated Intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in Autism Diagnostic Observation Schedule-2 (ADOS-2)

    Baseline, post (6 months), follow-up (12 months)

  • Change in Beck Depression Inventory

    Baseline, post (6 months)

  • Change in Beck Anxiety Inventory

    Baseline, post (6 months)

  • Change in Parent Stress Index

    Baseline, post (6 months)

  • Change in Behavior Rating Inventory of Executive Function-Preschool Version

    Baseline, post (6 months)

Other Outcomes (3)

  • Change in Parent Strategies Rating

    Baseline, months 1-6, and follow-up (12 months)

  • Change in Mullen Scales of Early Learning (MSEL)

    Baseline, post (6 months), follow-up (12 months)

  • Change in Vineland Adaptive Behavior Scales, Third Edition (VABS-III)

    Baseline, post (6 months), follow-up (12 months)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Treatment Condition

EXPERIMENTAL

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

Interventions

Treatment ConditionBEHAVIORAL

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.

Treatment Condition
Control GroupBEHAVIORAL

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

Control Group

Eligibility Criteria

Age1 Year - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine Center for Autism and the Developing Brain

White Plains, New York, 07302, United States

Location

Related Publications (1)

  • 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.

    PMID: 34925094DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • So Hyun Kim, Ph.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2017

First Posted

January 12, 2018

Study Start

October 13, 2017

Primary Completion

October 25, 2021

Study Completion

October 25, 2021

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations

US(1)