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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02428452
• Date of registration: 21/04/2015
• Prospective Registration: No
• Primary sponsor: Jessica Brian
• Public title: Social ABCs for Toddlers With Signs of Autism Spectrum Disorder: Trial of a Parent-Mediated Intervention
• Scientific title: Social ABCs for Toddlers With Signs of Autism Spectrum Disorder: RCT of a Parent-Mediated Intervention
• Date of first enrolment: May 2011
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02428452
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Susan Bryson, PhD
• Affiliation: IWK Health Centre / Dalhousie University

• Name: Jessica Brian, PhD
• Affiliation: Holland Bloorview Kids Rehabilitation / University of Toronto

Key inclusion & exclusion 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.



Age minimum: 12 Months
Age maximum: 30 Months
Gender: All

Health Condition(s) or Problem(s) studied

Autism Spectrum Disorder

Intervention(s)

Behavioral: Social ABCs parent-mediated intervention program

Primary Outcome(s)

Change from Baseline in Child Vocal Initiations at 12 and 24 weeks [Time Frame: Baseline, Week 12, Week 24]

Change from Baseline in Parent-Child Shared Smiling at 12 and 24 weeks [Time Frame: Baseline, Week 12, Week 24]

Change from Baseline in Child Vocal Responsivity at 12 and 24 weeks [Time Frame: Baseline, Week 12, Week 24]

Secondary Outcome(s)

Change from Baseline in Parent Fidelity of Implementation at 12 and 24 weeks [Time Frame: Baseline, Week 12, Week 24]

Secondary ID(s)

1005465

11-192

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

IWK Health Centre