Clinical trial NCT03397719: Parent Video Feedback Intervention Study
Official title: Parent Feedback Intervention Study: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Parent-Child Relations
Keywords: Autism Spectrum Disorder
Early Intervention
Parent-Mediated Intervention
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Brief Observation of Social Communication Change (BOSCC)
timeFrame: Baseline, months 1-6, and follow-up (12 months)
Secondary outcomes:
measure: Change in Autism Diagnostic Observation Schedule-2 (ADOS-2)
timeFrame: Baseline, post (6 months), follow-up (12 months)
measure: Change in Beck Depression Inventory
timeFrame: Baseline, post (6 months)
measure: Change in Beck Anxiety Inventory
timeFrame: Baseline, post (6 months)
measure: Change in Parent Stress Index
timeFrame: Baseline, post (6 months)
measure: Change in Behavior Rating Inventory of Executive Function-Preschool Version
timeFrame: Baseline, post (6 months)
Other outcomes:
measure: Change in Parent Strategies Rating
timeFrame: Baseline, months 1-6, and follow-up (12 months)
measure: Change in Mullen Scales of Early Learning (MSEL)
timeFrame: Baseline, post (6 months), follow-up (12 months)
measure: Change in Vineland Adaptive Behavior Scales, Third Edition (VABS-III)
timeFrame: Baseline, post (6 months), follow-up (12 months)
Locations:
city: White Plains
country: United States
facility: Weill Cornell Medicine Center for Autism and the Developing Brain
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: So Hyun Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.