Social ABCs for Toddlers With Signs of Autism Spectrum Disorder: Trial of a Parent-Mediated Intervention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02428452|
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Social ABCs parent-mediated intervention program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Social ABCs for Toddlers With Signs of Autism Spectrum Disorder: RCT of a Parent-Mediated Intervention|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Six-month Social ABCs parent-training program received immediately
Behavioral: Social ABCs parent-mediated intervention program
The 6-month Social ABCs parent-mediated intervention consists of 12 weeks of parent training and a 12 week implementation phase. 15 training (parent coaching) sessions are provided by a Research Trainer. Each session with the trainer includes a review of the program manual, practice of the techniques in the child's home, and a 15 min video of the parent-child dyad practicing the intervention. Week 9 and 11 are phone consultations. After the active training is complete, the parent enters the 12-week implementation phase, which includes practicing the techniques on their own, with no trainer instruction or contact. The trainer re-visits the parent and child at Week 24 to collect three 15 min videos; 2 generalization videos are also taken with an untrained examiner.
Other Name: Social ABCs
No Intervention: Control
Participants randomized to the Control group do not receive the Social ABCs parent training program for the 6-month control phase. Control participants may access other approved community services as outlined in the study protocol and consent during the Control Phase, which is considered 'treatment as usual'. After the 6-month Control Phase, participants are offered the Social ABCs parent training program.
- Change from Baseline in Child Vocal Responsivity at 12 and 24 weeks [ Time Frame: Baseline, Week 12, Week 24 ]Proportion of appropriate child vocal responses, following a parental prompt (reported as %).
- Change from Baseline in Child Vocal Initiations at 12 and 24 weeks [ Time Frame: Baseline, Week 12, Week 24 ]Number of child-initiated functional, appropriate vocalizations (rate/minute).
- Change from Baseline in Parent-Child Shared Smiling at 12 and 24 weeks [ Time Frame: Baseline, Week 12, Week 24 ]Percent of intervals where parent and child are smiling together.
- Change from Baseline in Parent Fidelity of Implementation at 12 and 24 weeks [ Time Frame: Baseline, Week 12, Week 24 ]The percentage of intervals during which parents demonstrate appropriate use of the techniques.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428452
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Holland Bloorview Kids Rehabilitation Hospital|
|Toronto, Ontario, Canada, M4G1R8|
|Principal Investigator:||Susan Bryson, PhD||IWK Health Centre / Dalhousie University|
|Principal Investigator:||Jessica Brian, PhD||Holland Bloorview Kids Rehabilitation / University of Toronto|