N/A
Completed N=57
A+ Treatment/Feasibility of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD (Autism Spectrum Disorder) and ADHD (Attention Deficit Hyperactivity Disorder)
Source: ClinicalTrials.gov NCT05417607 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Number of Caregivers and Staff Who Completed Individual Qualitative Interviews to Assess the Acceptability, Appropriateness, and Feasibility of the Intervention — 24; 5 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Caregivers and Staff Who Completed Individual Qualitative Interviews to Assess the Acceptability, Appropriateness, and Feasibility of the Intervention |
24; 5 | — |
| PRIMARY Feasibility of Intervention (as Measured by Feasibility of Intervention Measure, FIM) |
18.58 | — |
| PRIMARY Acceptability of Intervention (as Measured by the Acceptability of Intervention Measure, AIM) |
18.68 | — |
| PRIMARY Appropriateness of Intervention (as Measured by the Intervention Appropriateness Measure, IAM) |
18.21 | — |
| PRIMARY 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 |
3.75 | 0.0047 sig |
| SECONDARY Changes From Baseline (Pre-intervention) to 9-weeks (Post-intervention) in Caregiver Sense of Competence Measured by the Parent Sense of Competence Scale. |
2.21 | 0.2383 |
| SECONDARY Change From Baseline (Pre-intervention) to 9 Weeks (Post-intervention) in Child Behaviors as Measured by Joint Engagement Rating Inventory (JERI) |
-0.71 | 0.3426 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT05417607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.