Active Autistic Disorder, Asperger Syndrome, Autism, Autism Spectrum Disorder, Autistic Disorder, Mixed Expressive Receptive Language Disorder, Other Symbolic Dysfunctions, PDD-NOS, Social Communication Delay
Conditions
Keywords
Social Communication, Language, Engagement
Brief summary
The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social communication delays by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with either a social communication delay or ASD.
Detailed description
The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with ASD. The secondary hypothesis is that feasibility (defined as parent fidelity) of TC is non-inferior to IPC. An exploratory objective is to guide clinical decision-making for telehealth implementation by examining the heterogeneity of treatment response across the two treatment arms. The investigators will test the hypothesis that baseline child behavioral dysregulation, active engagement, developmental quotient, and parent stress moderate child social-communication outcomes. After completing eligibility testing, eligible children will be randomized into the TC or IPC condition. Each condition will involve twice weekly coaching sessions over 8-12 weeks. At the end of the intervention period, participants will be reassessed.
Interventions
BEHAVIORALEarly Achievements- Parent Coaching Intervention
Children, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.
Sponsors
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
United States Department of Defense
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All participants will receive the same outcome battery of assessments. The individual evaluating the child and all coders will be blind to condition.
Intervention model description
Upon confirmation of eligibility and completion of the baseline assessments, participants will be randomly assigned to the TC or IPC study condition. Randomization will be done in randomly permuted groups of different sizes to reduce predictability of treatment assignment, with one half of the parent-child dyads in each block assigned to the IPC arm and one half assigned to the TC condition.
Eligibility
Sex/Gender
ALL
Age
18 Months to 42 Months
Healthy volunteers
No
Inclusion criteria
* Meeting study criteria for ASD based on: * Autism Diagnostic Observation Schedule(ADOS) criteria for mild-to- moderate concern or greater (for children between 18 and 30 months) or algorithm cut-offs for ASD or autism (31-33 months), * Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)( criteria for ASD) * ASD diagnosis by clinician (clinical best estimate) by study team clinical research experts * Meeting study criteria for social communication delay based on: * Scoring a T score of \<35 on Expressive Language and/or Receptive Language subscales, Nonverbal developmental quotient of \> 50 (Visual Reception and Fine Motor subscales averaged) AND Visual reception \> 12 months * Nonverbal developmental quotient (DQ) of \> 63 based on the Visual Reception and Fine Motor subscales * Gestational age of 36-42 weeks; * Birth weight of \> 2,500 grams; * Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome, fragile X, tuberose sclerosis, neurofibromatosis) or severe sensory- motor (e.g., cerebral palsy) conditions. * Able to walk independently. * Children must produce at least three different types of intentional directed (with eye contact or pairing vocalization and gesture) nonverbal or verbal communicative acts per day, with clear and specific examples, per parent report in the Eligibility Interview.
Exclusion criteria
* Having a primary language other than English * Family lives \>40 miles from a Kennedy Krieger Institute-Center for Autism Services, Sciences, and Innovation (CASSI) site. * Child lives in foster care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Duration of Joint Attention | 8-12 weeks | 10 minute caregiver/child play samples will be coded using an engagement coding schema. The schema differentiates different levels of engagement. This data will be used to compare duration of engagement states at pre- and post-testing. |
| Parent Fidelity of Implementation | 8-12 weeks | Parent fidelity of implementation will be coded from the parent-child interaction sample obtained within the home at baseline and post-intervention by trained (to reliability) research assistants blind to group membership and timing of sample. This form consists of 26-items, where each item is rated using a 3-point Likert-type scale. Items reflect the key elements of Natural Developmental Behavioral Interventions (NDBI) which have been assessed in parent-implemented NDBI studies found to improve child social-communication outcomes. Ratings are based on effectiveness (well-timed, variety, developmental appropriateness) and frequency/consistency. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRebecca Landa, PhD
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
PRINCIPAL_INVESTIGATORRachel Reetzke, PhD
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Outcome results
None listed