Autism Spectrum DisorderNCT05417607
A+ Treatment/Feasibility of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD (Autism Spectrum Disorder) and ADHD (Attention Deficit Hyperactivity Disorder)
A study testing P-ESDM informed caregiver coaching in people with Autism Spectrum Disorder and Adhd, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 131 months
- Conditions the study is for
- Autism Spectrum Disorder, Adhd
- What is being tested?
- P-ESDM informed caregiver coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2020to 5 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 131 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sub-study: Feasibility Trial of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD and ADHD
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.
Read the 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 combination clinical trials (pharmacotherapy and behavioral intervention). Using an implementation science approach, the investigators will characterize the acceptability, appropriateness, feasibility and fidelity of remote behavioral intervention. Approximately 30-35 participants who are between 36 months and <132 months of age with comorbid ASD and ADHD will take part in this study, which includes parent coaching sessions completed remotely. Total participation is expected to require a maximum of 20 weeks, including optional remote follow-up at 16 weeks. The A+ Treatment diagnostic and screening visits will generally occur between 1 and 6 weeks prior to baseline. The provided behavioral treatment will be eight ~60-minute weekly sessions of ESDM-informed caregiver coaching delivered remotely through telehealth, for 8 consecutive weeks. Endpoint assessments will be completed after the final coaching visit. No medication will be provided by the study team. The final assessment will be obtained at 16 weeks after baseline.
- Conditions
- Autism Spectrum Disorder, Adhd
- Being tested
- P-ESDM informed caregiver coaching
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-ESDM informed caregiver coachingBehavioural
Caregiver coaching informed by P-ESDM done remotely (via telehealth)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: P-ESDM informed caregiver coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
The parent sense of competence scale is a self-report measure that assesses parenting sense of competence in 3- to 17-year-old children. It is a 16-item 6-point Likert scale questionnaire with ratings ranging from strongly agree (1) to strongly disagree (6). It includes 2 validated factors: satisfaction (9 items) and efficacy (7 items). The scale ranges from 16 to 96, where higher scores indicate greater competence. Change will be measured using the score at each timepoint.
Measured: Baseline, Week 9
Change From Baseline (Pre-intervention) to 9 Weeks (Post-intervention) in Child Behaviors as Measured by Joint Engagement Rating Inventory (JERI)
Joint Engagement Rating Inventory (JERI) contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. Reported is the change in the sum of 4 items from the JERI (Joint Engagement, Attention to Caregiver, Responsiveness to Partner's Communication Bids, Fluency and Connectedness) coded by a trained, reliable coder who is naïve with respect to whether the observation is from baseline our outcome using video-recorded caregiver-child interactions. The score range is 4 to 28, where a higher score indicates a greater amount of the aspect of joint engagement.
Measured: Baseline, Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start16 Dec 2020
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility trial
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Franz, M.B., CH.B., Principal investigator, Duke UniversityGeraldine Dawson, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417607
- Sponsor's protocol ID
- Pro00085179_1
- Status last verified
- Mar 2024
- First submitted
- 25 May 2022
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Through NDAR (National Database for Autism Research), core assessment and diagnostic data that is de-identified, including Vineland data and autism assessments.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-study: Feasibility Trial of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD and ADHD
- ClinicalTrials.gov ID
- NCT05417607
- Acronym / sponsor ID
- Pro00085179_1
- Conditions
- Autism Spectrum Disorder, Adhd
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Posted 26 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 combination clinical trials (pharmacotherapy and behavioral intervention). Using an implementation science approach, the investigators will characterize the acceptability, appropriateness, feasibility and fidelity of remote behavioral intervention. Approximately 30-35 participants who are between 36 months and <132 months of age with comorbid ASD and ADHD will take part in this study, which includes parent coaching sessions completed remotely. Total participation is expected to require a maximum of 20 weeks, including optional remote follow-up at 16 weeks. The A+ Treatment diagnostic and screening visits will generally occur between 1 and 6 weeks prior to baseline. The provided behavioral treatment will be eight ~60-minute weekly sessions of ESDM-informed caregiver coaching delivered remotely through telehealth, for 8 consecutive weeks. Endpoint assessments will be completed after the final coaching visit. No medication will be provided by the study team. The final assessment will be obtained at 16 weeks after baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility trial
| Arm | Type | Receives |
|---|---|---|
| A+ Treatment/Feasibility participants | Other | Behavioral: P-ESDM informed caregiver coachingTotal 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. |
Who may qualify
- Ages
- 36 to 131 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-ESDM informed caregiver coachingCaregiver coaching informed by P-ESDM done remotely (via telehealth) | Behavioural | A+ Treatment/Feasibility participants |
Primary outcome
Number of Caregivers and Staff Who Completed Individual Qualitative Interviews to Assess the Acceptability, Appropriateness, and Feasibility of the Intervention
Time frame: Week 9/Endpoint
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.
Feasibility of Intervention (as Measured by Feasibility of Intervention Measure, FIM)
Time frame: Week 9/Endpoint
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.
Acceptability of Intervention (as Measured by the Acceptability of Intervention Measure, AIM)
Time frame: Week 9/Endpoint
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.
Appropriateness of Intervention (as Measured by the Intervention Appropriateness Measure, IAM)
Time frame: Week 9/Endpoint
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.
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
Time frame: Baseline, Week 9
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.
2 secondary outcomes
Changes From Baseline (Pre-intervention) to 9-weeks (Post-intervention) in Caregiver Sense of Competence Measured by the Parent Sense of Competence Scale.
Time frame: Baseline, Week 9
Change From Baseline (Pre-intervention) to 9 Weeks (Post-intervention) in Child Behaviors as Measured by Joint Engagement Rating Inventory (JERI)
Time frame: Baseline, Week 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Through NDAR (National Database for Autism Research), core assessment and diagnostic data that is de-identified, including Vineland data and autism assessments.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Franz, M.B., CH.B. principal investigator
Duke University
Geraldine Dawson, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P-ESDM informed caregiver coaching in people with Autism Spectrum Disorder and Adhd, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Caregivers and Staff Who Completed Individual Qualitative Interviews to Assess the Acceptability, Appropriateness, and Feasibility of the Intervention (time frame: Week 9/Endpoint). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.