NCT02428452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

3.8 years

First QC Date

April 21, 2015

Last Update Submit

July 11, 2017

Conditions

Autism Spectrum Disorder

Keywords

autismAutism SPectrum Disorderearly interventioninfanttoddlerearly identificationpivotal response training (PRT)control grouptreatment groupat risksocial communicationpositive affectsmiling

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Change from Baseline in Parent Fidelity of Implementation at 12 and 24 weeks

    Baseline, Week 12, Week 24

Study Arms (2)

Treatment

EXPERIMENTAL

Six-month Social ABCs parent-training program received immediately

Behavioral: Social ABCs parent-mediated intervention program

Control

NO INTERVENTION

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.

Interventions

Social ABCs parent-mediated intervention programBEHAVIORAL

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.

Also known as: Social ABCs
Treatment

Eligibility Criteria

Age12 Months - 30 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

Location

Related Publications (1)

  • Brian JA, Smith IM, Zwaigenbaum L, Bryson SE. Cross-site randomized control trial of the Social ABCs caregiver-mediated intervention for toddlers with autism spectrum disorder. Autism Res. 2017 Oct;10(10):1700-1711. doi: 10.1002/aur.1818. Epub 2017 Jun 2.

    PMID: 28574669DERIVED

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderCommunicationSmiling

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehaviorFacial ExpressionNonverbal Communication

Study Officials

  • Susan Bryson, PhD

    IWK Health Centre / Dalhousie University

    PRINCIPAL INVESTIGATOR

  • Jessica Brian, PhD

    Holland Bloorview Kids Rehabilitation / University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Psychologist, Clinician-Investigator

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 28, 2015

Study Start

May 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

CA(2)