Autism Spectrum Disorder Clinical Trial
Official title:
Social ABCs for Toddlers With Signs of Autism Spectrum Disorder: RCT of a Parent-Mediated Intervention
Verified date | July 2017 |
Source | Holland Bloorview Kids Rehabilitation Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 30 Months |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | Holland Bloorview Kids Rehabilitation Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Jessica Brian | IWK Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in Child Vocal Responsivity at 12 and 24 weeks | Proportion of appropriate child vocal responses, following a parental prompt (reported as %). | Baseline, Week 12, Week 24 | |
Primary | Change from Baseline in Child Vocal Initiations at 12 and 24 weeks | Number of child-initiated functional, appropriate vocalizations (rate/minute). | Baseline, Week 12, Week 24 | |
Primary | Change from Baseline in Parent-Child Shared Smiling at 12 and 24 weeks | Percent of intervals where parent and child are smiling together. | Baseline, Week 12, Week 24 | |
Secondary | Change from Baseline in Parent Fidelity of Implementation at 12 and 24 weeks | The percentage of intervals during which parents demonstrate appropriate use of the techniques. | Baseline, Week 12, Week 24 |
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