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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04501588
Other study ID # STU00201708
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 6, 2020
Est. completion date November 24, 2021

Study information

Verified date January 2022
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

As a result of the COVID-19 pandemic, telecoaching/telepractice models are of urgent importance. Given this, parents in the study will receive parent coaching through weekly video calls. To help us understand the best types of telecoaching, we will offer all participants responsive coaching, with half of the participants receiving an additional opportunity to reflect on their own use of language strategies with a therapist using video feedback and the other half receiving responsive coaching as usual, without video feedback. This information is important in helping us to understand the best way to coach parents using a telepractice model so that parents implement the intervention at high fidelity. Furthermore, we will aim to understand how parent learning style may also influence the implementation of these strategies.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date November 24, 2021
Est. primary completion date September 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Months to 48 Months
Eligibility Inclusion Criteria: Child inclusion criteria include: - diagnosis of ASD or showing signs of ASD based on autism screening - chronological age of less than 48 months - a parent who is willing to learn intervention strategies - English as the primary language spoken in the home Parent inclusion criteria include: - Biological Mother Exclusion Criteria: - Children or parents with additional impairments (e.g., blindness, deafness, genetic syndromes) will be excluded from the study. - Fathers or caregivers other than the child's Mother will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Responsive training with no video feedback
Parents will receive responsive training, but will not watch themselves on video to reflect on their strategy use.
Responsive training with video feedback
Parents will receive responsive training and watch themselves on video to reflect on their strategy use.

Locations

Country Name City State
United States Northwestern University Evanston Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Roberts MY, Kaiser AP. Early intervention for toddlers with language delays: a randomized controlled trial. Pediatrics. 2015 Apr;135(4):686-93. doi: 10.1542/peds.2014-2134. Epub 2015 Mar 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Parent Use of Language Support Strategies (Mother-child interaction) Mother use of intervention strategies will be measured by transcribing and coding mother behaviors during 12-minute parent-child interactions, using a standard set of toys. The primary dependent variable will be the amount of correct strategy used expressed as a percentage correct. This is the percentage of child communication to which the adult responds correctly (i.e., contingently and within 5 seconds). Two months after the start of the study
Secondary MacArthur-Bates Communicative Development Inventory (MCDI) (Child) Parent report of child's expressive vocabulary and prelinguistic communication skills Two months after the start of the study
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