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Evaluation of Social ABCs With Attention Training Intervention for Toddlers With Suspected Autism

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ClinicalTrials.gov Identifier: NCT03215394
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : July 14, 2017
Sponsor:
Collaborators:
IWK Health Centre
Dalhousie University
University of Alberta
University of East London
University of London
Information provided by (Responsible Party):
Jessica Brian, Holland Bloorview Kids Rehabilitation Hospital

Brief Summary:

The Social ABCs is an evidence-based, developmentally informed, caregiver-mediated behavioural intervention for toddlers with suspected or confirmed Autism Spectrum Disorder (ASD). It is based on principles of Pivotal Response Treatment (PRT, grounded in Applied Behaviour Analysis), and responsive parenting. The two key targets of this program are functional verbal communication and positive caregiver-child affect sharing. This intervention takes place in the context of play and daily routines, and in all contexts is made to be fun.

In both a pilot study and a recently completed randomized control trial, toddlers whose caregivers received training in the Social ABCs intervention showed significant gains in early language development (both responsivity and initiations), increased child smiling (mediated by parent smiling), and a trend toward increased social orienting (one important manifestation of social attention).

Despite the social-communication benefits demonstrated through the Social ABCs, the research team is also motivated to foster the attentional abilities of toddlers with emerging ASD in response to compelling evidence that early attentional control abilities may play a central role in the emergence of ASD. Based on this knowledge, the current study targets not only social-communication challenges and affect sharing (as per the existing Social ABCs intervention), but also attentional control in toddlers with suspected or confirmed ASD. Using a structured, computerized attention-training protocol, this RCT evaluates the impact of supplementing the standard Social ABCs intervention with pre-intervention attentional control training.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Attention Training Program Behavioral: Social ABCs Other: Treatment As Usual Behavioral: Sham Attention Training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Social ABCs With Attention Training Intervention for Toddlers With Autism
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enhanced Social ABCs
Receive 4-week attention training program, followed by 12-week Social ABCs intervention. The stimuli include four gaze-contingent training tasks that will be presented on a laptop screen using custom MATLAB scripts. Each task will be presented until the infant becomes inattentive, at which point they will go to the next task or take a break. Training stimuli will be presented until toddlers become fidgety or distressed.
Behavioral: Attention Training Program
The attention training involves 8 visits over 4 weeks with pre/post data collection before and after the training, and a follow-up 6 months later. Pre/post data collection involves the ESCS and a Laboratory Temperament Assessment Battery (LabTAB), and a series of on-screen assessment tasks that measure cognitive control, distraction tolerance, sustained attention, habituation, gap-overlap, disengagement, and attention to static images. Training runs from Wk 2-5 with 2 visits per week and is completed in home with the child sitting on the parents lap in front of a monitor. The parent and child are inside a tent to reduce environmental stimuli. The research trainer is outside the tent running the program from a laptop. The program consists of a battery of 9 gaze-contingent training tasks using custom MATLAB scripts. The animated tasks are designed to engage the child and present as developmentally appropriate games. At each visit 6 of the 9 tasks will run for a total of 4min each(24min).

Behavioral: Social ABCs
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.

Sham Comparator: Standard Social ABCs
Receive 4-week sham attention program, followed by 12-week Social ABCs intervention. Sham attention condition will use identical hardware, administered by the same research staff for the same frequency and duration as the attention training intervention. Infants are exposed to non-gaze contingent visual stimuli that offer no adaptive difficulty levels (infant appropriate television clips and animations). Sham attention stimuli will be presented until toddlers become fidgety or distressed.
Behavioral: Social ABCs
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.

Behavioral: Sham Attention Training
The sham attention condition will use identical hardware, administered by the same research staff for the same frequency and duration as the attention training program (8 visits over 4 weeks including pre/post data collection). In this condition, infants will be exposed to non-gaze contingent visual stimuli that offer no adaptive difficulty levels (ie. clips of age appropriate television shows). Placebo stimuli will be presented until toddlers become fidgety or distressed.

Treatment As Usual
A convenience sample of age-equivalent toddlers who meet clinical eligibility criteria but are otherwise unable or unwilling to participate in the interventions, will be used as a Treatment as Usual comparison group. The same assessments will be administered at parallel time points through an existing research study. Receive no attention training program and no Social ABCs.
Other: Treatment As Usual
The Treatment as Usual group acts as a pre-existing convenience sample, consisting of families currently enrolled in a different approved research study run by the same group of investigators. Children in this group have comparable clinical concerns for ASD, and complete the same standardized measures (ADOS, MSEL, ESCS, AOSI) as the Baseline assessment in this RCT, but will not receive Social ABCs or the Attention Training Program. They are able to access any programs or interventions available to them in the general community. This is tracked on a Services Log form, included as part of that study's protocol. Families in this group will have consented to their child's data being shared across studies in this research group.




Primary Outcome Measures :
  1. Improved Attentional Flexibility [ Time Frame: Week 1 (baseline) and Week 6 ]
    Reaction time in Gap-Overlap task (milliseconds)

  2. Improved Attentional Control [ Time Frame: Week 1 (baseline) and Week 6 ]
    Percentage of correct trials in a computer-based attention task (%)

  3. Increased Social Orienting to Parent [ Time Frame: Week 1 (baseline), Week 6, Week 18, and Week 30 ]
    Percentage of intervals in which child is oriented to caregiver (%)

  4. Increased Child Smiling [ Time Frame: Week 1 (baseline), Week 6, Week 18, and Week 30 ]
    Percentage of intervals in which caregiver and child are smiling together (%)

  5. Increased Child Responsivity to Parent Prompt [ Time Frame: Week 1 (baseline), Week 6, Week 18, and Week 30 ]
    Gains in proportion of appropriate child vocal responses, following a caregiver prompt (reported as percentage).


Secondary Outcome Measures :
  1. Parent Fidelity of Implementation [ Time Frame: Week 6, Week 18, and Week 30 ]
    Percentage of intervals during which parents demonstrate appropriate use of the Social ABCs techniques (%)

  2. Receptive Language [ Time Frame: Week 0 and Week 30 ]
    Standard score on the Mullen Early Learning Scale (SS)

  3. Expressive Language [ Time Frame: Week 0 and Week 30 ]
    Standard score on the Mullen Early Learning Scale (SS)

  4. Joint Attention [ Time Frame: Week 0 and Week 30 ]
    Frequency of joint attentions bids on the Mini Early Social Communication (#)Scales



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The child must be 12-30 months of age with clinically significant signs of ASD (must be under 30 months at study enrollment to be included)
  • The toddler and parents must live together, and no more than 50km from the study site
  • Child is at home with the caregiver at least 50% of the time (no more than 2.5 days a week in child care, nanny, family care, etc.)
  • The child must not be involved in other behavioural interventions, such as ABA/IBI and the Hanen programs, for the duration of the study
  • The child may participate in no more than 1 hour per week (monthly average) of the following interventions: speech/language, occupational, and physical therapy, for the duration of the study
  • The child's diet and medications have not recently been drastically altered, and are not intended to be altered throughout the study.
  • The child does not have other neurological disorders (including epilepsy), genetic syndromes that have known association with ASD (e.g., Fragile X syndrome), significant uncorrected sensory impairments (vision, hearing, etc.), or low birth weight (under 2500g).
  • The child is not actively experiencing a regression of skills
  • The caregiver is conversant in English and could be coached in English
  • The child's eyes are successfully tracked with the eye-tracking technology used throughout the study.

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): NCT03215394


Contacts
Contact: Jessica Brian, PhD 4164256220 ext 3716 jbrian@hollandbloorview.ca

Locations
Canada, Alberta
University of Alberta - Autism Research Centre Recruiting
Edmonton, Alberta, Canada, T5G 0B7
Contact: Lonnie Zwaigenbaum, MD,FRCPC    780-735-6114    Lonnie.Zwaigenbaum@albertahealthservices.ca   
Contact: Sanne Jilderda, BSc    (780) 735-6274    sanne.jilderda@ahs.ca   
Principal Investigator: Lonnie Zwaigenbaum, MD,FRCPC         
Canada, Nova Scotia
IWK Health Centre / Dalhousie University Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Isabel Smith, Phd    902-470-7275    Isabel.Smith@iwk.nshealth.ca   
Contact: Stacey MacWilliam, BEd    902-470-7275    Stacey.MacWilliam@iwk.nshealth.ca   
Principal Investigator: Susan Bryson, PhD         
Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital Recruiting
Toronto, Ontario, Canada, M4G1R8
Contact: Jessica Brian, PhD    416-425-6220 ext 3716    jbrian@hollandbloorview.ca   
Contact: Kate Bernardi, BA    416-425-6220 ext 3410    kbernardi@hollandbloorview.ca   
Principal Investigator: Jessica Brian, PhD         
United Kingdom
University of East London Active, not recruiting
London, United Kingdom, E16 2RD
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
IWK Health Centre
Dalhousie University
University of Alberta
University of East London
University of London

Publications:
Responsible Party: Jessica Brian, Psychologist, Clinician Investigator, Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03215394     History of Changes
Other Study ID Numbers: 16-666
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jessica Brian, Holland Bloorview Kids Rehabilitation Hospital:
autism
autism spectrum disorder
Social ABCs
Early Intervention
Toddler
Early Identification
Pivotal Response Treatment
ASD
PRT
Control Group
treatment Group
At Risk
Social Communication
Positive Affect
Smiling
Social Orienting
Attentional Control
Attentional Disengagement
Naturalistic Developmental Behaviour Intervention
NDBI

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