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Social ABCs for Toddlers With Signs of Autism Spectrum Disorder: Trial of a Parent-Mediated Intervention

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ClinicalTrials.gov Identifier: NCT02428452
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
IWK Health Centre
Information provided by (Responsible Party):
Jessica Brian, Holland Bloorview Kids Rehabilitation Hospital

Brief Summary:
The Social ABCs is an innovative parent-mediated intervention for toddlers with confirmed or suspected Autism Spectrum Disorder (ASD). The intervention draws on what is known about core, early emerging impairments in ASD, and on evidence-based Pivotal Response Treatment (PRT) and associated parent training programs for enhancing development in children with ASD. Completion of a comprehensive pilot study set the stage for a randomized control trial (RCT) of the Social ABCs. The purpose of this RCT is to evaluate the efficacy of the Social ABCs intervention program on improving spoken language skills and positive parent-child emotion sharing in toddlers with signs of or a diagnosis of ASD.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Social ABCs parent-mediated intervention program Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
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.



Primary Outcome Measures :
  1. 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 %).

  2. 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).

  3. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   12 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child is 12-30 months of age and no greater than 31 months prior to baseline data collection.
  • Lives within a 50 km radius of study site.
  • Child attends less than 2.5 days/week of child care and is cared for at home by primary caregiver at least 3 days a week.
  • Child meets assessment eligibility based on either their Autism Observation Scale for Infants (AOSI) scores (Total = 9+) or Autism Diagnostic Observation Scale (ADOS) scores (A+B Total = 7+) or clinical impressions of ASD risk made by the Principal Investigator or professional administering baseline assessments.
  • Family agrees not to participate in a Intensive Behavioral Intervention (IBI) or Applied Behavioural Analysis (ABA) program while participating in the treatment group.
  • Family agrees to delay participation in municipal speech therapy workshops (ie. Hanen Workshops, All Together Now, etc.) for the duration of the study while participating in the treatment group.
  • Child has no other known neurological disorders ( i.e. Epilepsy, severe vision or hearing impairment, etc.).
  • Child is not experiencing a significant regression.
  • Child has not started any new medication and is medically stable in the past 6 weeks. (If not, family must wait 6 weeks after starting medication before joining the study).
  • Child has not started/stopped any major diet/vitamin protocols in the past three months, and family is willing to refrain from starting any during the treatment phase.
  • Family is willing to limit other interventions such as Speech and Language, Occupation or Physical Therapy to no more than 1 hour each per week.
  • Parent has not been trained previously on Social ABCs or other parent training programs such as the Nova Scotia Early Intensive Behavioural Intervention program, that teach parents how to implement PRT.
  • Parent has a strong understanding of, and communicates effectively in English.

Exclusion Criteria:

  • Participant fails to meet any of the above listed Inclusion Criteria.

Information from the National Library of Medicine

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


Locations
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Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada, M4G1R8
Sponsors and Collaborators
Jessica Brian
IWK Health Centre
Investigators
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Principal Investigator: Susan Bryson, PhD IWK Health Centre / Dalhousie University
Principal Investigator: Jessica Brian, PhD Holland Bloorview Kids Rehabilitation / University of Toronto

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jessica Brian, Psychologist, Clinician-Investigator, Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02428452     History of Changes
Other Study ID Numbers: 11-192
1005465 ( Other Identifier: IWK Health Centre )
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Jessica Brian, Holland Bloorview Kids Rehabilitation Hospital:
autism
Autism SPectrum Disorder
early intervention
infant
toddler
early identification
pivotal response training (PRT)
control group
treatment group
at risk
social communication
positive affect
smiling

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders