Parent Video Feedback Intervention Study

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder; Parent-Child Relations
• Interventions: Behavioral: Control Group; Behavioral: Treatment Condition

• Registration Number: NCT03397719
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-10-13
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-12
• Status Verified: 2021-10
• Primary Completion: 2021-10-25
• Study Completion: 2021-10-25
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	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.
Treatment Condition	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.

Primary Outcome Measures

Name	Time	Method
Change in Brief Observation of Social Communication Change (BOSCC)	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 Outcome Measures

Name	Time	Method
Change in Beck Depression Inventory	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.
Change in Autism Diagnostic Observation Schedule-2 (ADOS-2)	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.
Change in Beck Anxiety Inventory	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.
Change in Parent Stress Index	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.
Change in Behavior Rating Inventory of Executive Function-Preschool Version	Baseline, post (6 months)	Standardized rating scale designed to specifically measure the range of behavioral manifestations of executive function in preschool-aged children

Trial Locations

Locations (1)

Weill Cornell Medicine Center for Autism and the Developing Brain; 🇺🇸 White Plains, New York, United States