Status:
COMPLETED
A+ Treatment/Feasibility of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD (Autism Spectrum Disorder) and ADHD (Attention Deficit Hyperactivity Disorder)
Lead Sponsor:
Duke University
Conditions:
Autism Spectrum Disorder
Adhd
Eligibility:
All Genders
36-131 years
Phase:
NA
Brief Summary
This study will evaluate the feasibility of adapted ESDM-informed caregiver coaching in children with comorbid ASD and ADHD, who are between 36 and \<132 months of age. There will be no study provided...
Detailed Description
The overarching goal of A+ Treatment is to evaluate feasibility and gather pilot data of remotely-delivered ESDM informed caregiver coaching for children with ASD and ADHD which may inform future comb...
Eligibility Criteria
Inclusion
- Provision of a parent/guardian signed and dated informed consent form.
- Stated willingness of parent/guardian to comply with all study procedures and availability for the duration of the study.
- Child is between 36 months and \<132 months of age at baseline.
- Child has a confirmed DSM-5 diagnosis of both ASD and ADHD, informed by results of assessments including: an ASD diagnostic assessment (Brief Observation of Symptoms of Autism \[BOSA\], Autism Diagnostic Observation Schedule, 2nd Edition \[ADOS-2\], or TELE-ASD-PEDS, and if applicable the Autism Diagnostic Interview - Revised \[ADI-R\]) and an ADHD diagnostic (a standardized ADHD Diagnostic Interview and the MINI psychiatric diagnostic interview).
Exclusion
- If continuing psychotropic (CNS-active) medications, must not have been changed within 4 weeks prior to baseline.
- Significant visual, auditory or motor impairments that would preclude participation in ESDM-informed caregiver coaching or completion of key assessments.
- Inability of the caregiver participating in ESDM-informed caregiver coaching and responding to questionnaires to fluently speak English.
- Study clinician judgment that it is not in the best interests of the participant and/or the study for the child to participate (including presence of psychiatric conditions or psychiatric symptoms in addition to ASD and ADHD that in the opinion of the PI or based on senior clinical review, would confound assessments and/or affect participation in the study).
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2022
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT05417607
Start Date
December 16 2020
End Date
April 5 2022
Last Update
March 26 2024
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27705