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 | Completed Results DMC

• 1 other identifier: Pro00085179_1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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 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

Autism Spectrum Disorder; Adhd

Outcome Measures

Primary Outcomes (5)

• Number of Caregivers and Staff Who Completed Individual Qualitative Interviews to Assess the Acceptability, Appropriateness, and Feasibility of the Intervention

  Questions are tailored to stakeholder group and are informed by previous studies that have examined barriers and facilitators during the implementation of a new treatment approach. Interviews will be conducted after completing coaching sessions. Qualitative analysis will use an iterative coding and review process informed by grounded theory.

  Week 9/Endpoint

• Feasibility of Intervention (as Measured by Feasibility of Intervention Measure, FIM)

  The FIM is a four-item implementation outcome measure that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Each item is rated on a 5-point ordinal scale from 1 (completely disagree) to 5 (completely agree). The sum of ratings across all 4 items ranges from 4 to 20, where higher scores indicate greater feasibility, and lower scores indicate lower feasibility.

  Week 9/Endpoint

• Acceptability of Intervention (as Measured by the Acceptability of Intervention Measure, AIM)

  The AIM is a four-item implementation outcome measure that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Each item is rated on a 5-point ordinal scale from 1 (completely disagree) to 5 (completely agree). The sum of ratings across all 4 items ranges from 4 to 20, where higher scores indicate greater acceptability, and lower scores indicate lower acceptability.

  Week 9/Endpoint

• Appropriateness of Intervention (as Measured by the Intervention Appropriateness Measure, IAM)

  The IAM is a four-item implementation outcome measure that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Each item is rated on a 5-point ordinal scale from 1 (completely disagree) to 5 (completely agree). The sum of ratings across all 4 items ranges from 4 to 20, where higher scores indicate greater appropriateness, and lower scores indicate lower appropriateness.

  Week 9/Endpoint

• Changes From Baseline (Pre-intervention) to Week 9 (Post-intervention) in Fidelity of Intervention Delivery Using an Adapted Version of the Parent Early Start Denver Model (P-ESDM) Caregiver Fidelity Rating System

  The caregiver fidelity rating system measure assesses fidelity of the caregiver in using ESDM principles during a joint activity with their child using ratings of performance on 13 items (1-5 scale). The sum of ratings is used for a total score, ranging from 13 to 65, where higher score is greater fidelity and lower scores indicate lower fidelity.

  Baseline, Week 9

Secondary Outcomes (2)

• Changes From Baseline (Pre-intervention) to 9-weeks (Post-intervention) in Caregiver Sense of Competence Measured by the Parent Sense of Competence Scale.

  Baseline, Week 9

• Change From Baseline (Pre-intervention) to 9 Weeks (Post-intervention) in Child Behaviors as Measured by Joint Engagement Rating Inventory (JERI)

  Baseline, Week 9

Study Arms (1)

A+ Treatment/Feasibility participants

OTHER

Total participation is expected to require a maximum of 20 weeks (plus optional remote follow-up at 16 week). Diagnostic/screening visits occur between 1 and 6 weeks prior to baseline and start of coaching. ESDM-informed parent coaching (\~1 hour sessions) is delivered remotely (through telehealth) with a study clinician for 8 weeks and strategies are implemented within the child's typical daily routines by the caregiver. No medication is provided by the study team. Data is collected weekly and final assessment will be obtained at 16 weeks after baseline.

Behavioral: P-ESDM informed caregiver coaching

Interventions

P-ESDM informed caregiver coaching BEHAVIORAL

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

A+ Treatment/Feasibility participants

Eligibility Criteria

• Age: 36 Months - 131 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Results Point of Contact

• Title: Lauren Franz MBChB, MPH
• Organization: Duke University

lauren.franz@duke.edu

919-681-0023

Study Officials

• Lauren Franz, M.B., CH.B.

  Duke University

  PRINCIPAL INVESTIGATOR

• Geraldine Dawson, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility trial

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 14, 2022
• Study Start: December 16, 2020
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: March 26, 2024
• Results First Posted: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after publication of the results for each of the specific aims or 3 years after the statistical analyses are completed
• Access Criteria: determined by committee of researchers/administrator at NDAR

Locations

US (1)