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A+ Treatment/Feasibility of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD (Autism Spectrum Disorder) and ADHD (Attention Deficit Hyperactivity Disorder)

NCT05417607 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-03-26

Study results available
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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 medication treatment in this study. Children will either be on ADHD medication prescribed by their own personal provider or will not be taking any ADHD medication (this will be documented by the study). The provided behavioral treatment will be eight \~60-minute sessions in ESDM-informed caregiver coaching delivered remotely through telehealth, for 8 consecutive weeks. The behavioral treatment is provided to children through Early Start Denver Model (ESDM)-informed caregiver coaching strategies, implemented within the child's typical daily routine by the caregiver.

Conditions

Interventions

BEHAVIORAL

P-ESDM informed caregiver coaching

Caregiver coaching informed by P-ESDM done remotely (via telehealth)

Sponsors & Collaborators

Principal Investigators

  • Lauren Franz, M.B., CH.B. · Duke University

  • Geraldine Dawson, PhD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
36 Months
Max Age
131 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2022-04-05
Completion
2022-04-05

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05417607 on ClinicalTrials.gov