CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
P-ESDM informed caregiver coachingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05417607
NCT05417607N/ACompleted

Sub-study: Feasibility Trial of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD and ADHD

Duke University·interventional·Posted Jun 14, 2022·Updated Mar 26, 2024

In Brief

A clinical study evaluating P-ESDM informed caregiver coaching for Autism Spectrum Disorder and Adhd. Completed, enrolled 57 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 14, 2022
Enrollment StartDec 16, 2020
Primary CompletionApr 5, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.0 years ago

Interventions

P-ESDM informed caregiver coachingbehavioral

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