Trial Outcomes & Findings for A+ Treatment/Feasibility of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD (Autism Spectrum Disorder) and ADHD (Attention Deficit Hyperactivity Disorder) (NCT NCT05417607)

Last Updated: 2024-03-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

57 participants

Primary outcome timeframe

Week 9/Endpoint

Results posted on

2024-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	A+ Treatment Caregiver-Child Dyads - Caregivers Participants in this arm will be caregivers of children with ASD (Autism Spectrum Disorder) and/or ADHD (Attention Deficit Hyperactivity Disorder). 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Caregiver-Child Dyads - Children Participants in this arm will be children with ASD (Autism Spectrum Disorder) and/or ADHD (Attention Deficit Hyperactivity Disorder). 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Staff Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)
Overall Study STARTED	26	26	5
Overall Study COMPLETED	24	24	5
Overall Study NOT COMPLETED	2	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A+ Treatment Caregiver-Child Dyads - Caregivers Participants in this arm will be caregivers of children with ASD and/or ADHD. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Caregiver-Child Dyads - Children n=26 Participants Participants in this arm will be children with ASD and/or ADHD. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Staff Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	Total n=26 Participants Total of all reporting groups
Age, Continuous	—	103.4 months STANDARD_DEVIATION 19.8 • n=4 Participants	—	103.4 months STANDARD_DEVIATION 19.8 • n=483 Participants
Sex: Female, Male Female	—	6 Participants n=4 Participants	—	6 Participants n=483 Participants
Sex: Female, Male Male	—	20 Participants n=4 Participants	—	20 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	1 Participants n=4 Participants	—	1 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	25 Participants n=4 Participants	—	25 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=4 Participants	—	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=4 Participants	—	0 Participants n=483 Participants
Race (NIH/OMB) Asian	—	0 Participants n=4 Participants	—	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=4 Participants	—	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	—	6 Participants n=4 Participants	—	6 Participants n=483 Participants
Race (NIH/OMB) White	—	15 Participants n=4 Participants	—	15 Participants n=483 Participants
Race (NIH/OMB) More than one race	—	5 Participants n=4 Participants	—	5 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=4 Participants	—	0 Participants n=483 Participants
Region of Enrollment United States	—	26 Participants n=4 Participants	—	26 Participants n=483 Participants

PRIMARY outcome

Timeframe: Week 9/Endpoint

Population: Caregivers and staff who completed the individual qualitative interviews. Caregivers responded to the questions for both themselves and their child.

Outcome measures

Outcome measures
Measure	A+ Treatment Caregiver-Child Dyads - Caregivers n=24 Participants Participants in this arm will be caregivers of children with ASD (Autism Spectrum Disorder) and/or ADHD (Attention Deficit Hyperactivity Disorder). 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Staff n=5 Participants Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)
Number of Caregivers and Staff Who Completed Individual Qualitative Interviews to Assess the Acceptability, Appropriateness, and Feasibility of the Intervention	24 Participants	5 Participants

PRIMARY outcome

Timeframe: Week 9/Endpoint

Population: Caregivers who completed the FIM. Caregivers responded to the questions for both themselves and their child. Data not collected on staff.

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.

Outcome measures

Outcome measures
Measure	A+ Treatment Caregiver-Child Dyads - Caregivers n=19 Participants Participants in this arm will be caregivers of children with ASD (Autism Spectrum Disorder) and/or ADHD (Attention Deficit Hyperactivity Disorder). 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Staff Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)
Feasibility of Intervention (as Measured by Feasibility of Intervention Measure, FIM)	18.58 score on a scale Standard Deviation 1.98	—

PRIMARY outcome

Timeframe: Week 9/Endpoint

Population: Caregivers who completed the AIM. Caregivers responded to the questions for both themselves and their child. Data not collected on staff.

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.

Outcome measures

Outcome measures
Measure	A+ Treatment Caregiver-Child Dyads - Caregivers n=19 Participants Participants in this arm will be caregivers of children with ASD (Autism Spectrum Disorder) and/or ADHD (Attention Deficit Hyperactivity Disorder). 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Staff Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)
Acceptability of Intervention (as Measured by the Acceptability of Intervention Measure, AIM)	18.68 score on a scale Standard Deviation 1.73	—

PRIMARY outcome

Timeframe: Week 9/Endpoint

Population: Caregivers who completed the IAM. Caregivers responded to the questions for both themselves and their child. Data not collected on staff.

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.

Outcome measures

Outcome measures
Measure	A+ Treatment Caregiver-Child Dyads - Caregivers n=19 Participants Participants in this arm will be caregivers of children with ASD (Autism Spectrum Disorder) and/or ADHD (Attention Deficit Hyperactivity Disorder). 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Staff Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)
Appropriateness of Intervention (as Measured by the Intervention Appropriateness Measure, IAM)	18.21 score on a scale Standard Deviation 2.66	—

PRIMARY outcome

Timeframe: Baseline, Week 9

Population: Caregiver-child dyads who completed the study. Caregivers responded to the questions for both themselves and their child. Data not collected on staff.

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.

Outcome measures

Outcome measures
Measure	A+ Treatment Caregiver-Child Dyads - Caregivers n=24 Participants Participants in this arm will be caregivers of children with ASD (Autism Spectrum Disorder) and/or ADHD (Attention Deficit Hyperactivity Disorder). 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Staff Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)
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 score on a scale Interval 1.27 to 6.22	—

SECONDARY outcome

Timeframe: Baseline, Week 9

Population: Caregivers who completed the Parent Sense of Competence Scale. Data not collected on children or staff.

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.

Outcome measures

Outcome measures
Measure	A+ Treatment Caregiver-Child Dyads - Caregivers n=19 Participants Participants in this arm will be caregivers of children with ASD (Autism Spectrum Disorder) and/or ADHD (Attention Deficit Hyperactivity Disorder). 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Staff Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)
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 score on a scale Standard Deviation 7.9	—

SECONDARY outcome

Timeframe: Baseline, Week 9

Population: Caregiver-child dyads who completed the study. Caregivers responded to the questions for both themselves and their child. Data not collected on staff.

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.

Outcome measures

Outcome measures
Measure	A+ Treatment Caregiver-Child Dyads - Caregivers n=24 Participants Participants in this arm will be caregivers of children with ASD (Autism Spectrum Disorder) and/or ADHD (Attention Deficit Hyperactivity Disorder). 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Staff Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)
Change From Baseline (Pre-intervention) to 9 Weeks (Post-intervention) in Child Behaviors as Measured by Joint Engagement Rating Inventory (JERI)	-0.71 score on a scale Standard Deviation 3.58	—

Adverse Events

A+ Treatment Caregiver-Child Dyads - Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

A+ Treatment Caregiver-Child Dyads - Children

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

A+ Treatment Staff

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Lauren Franz MBChB, MPH

Duke University

Phone: 919-681-0023

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	A+ Treatment Caregiver-Child Dyads - Caregivers Participants in this arm will be caregivers of children with ASD and/or ADHD. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Caregiver-Child Dyads - Children n=26 participants at risk Participants in this arm will be children with ASD and/or ADHD. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)	A+ Treatment Staff Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. 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. Early Start Denver Model (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. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth)
Injury, poisoning and procedural complications Abrasions of extremities	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Psychiatric disorders Aggression	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	7.7% 2/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Psychiatric disorders Agitation	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Immune system disorders Allergic hypersensitivity	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	7.7% 2/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Psychiatric disorders Anxiety	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	11.5% 3/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Gastrointestinal disorders Constipation	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Psychiatric disorders Depressed mood	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Psychiatric disorders Disturbance in attention	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Skin and subcutaneous tissue disorders Eczema	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Gastrointestinal disorders Encopresis	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Renal and urinary disorders Enuresis	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Psychiatric disorders Frustration	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	7.7% 2/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Gastrointestinal disorders Gastrointestinal upset	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	11.5% 3/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Gastrointestinal disorders Gastrointestinal virus	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Nervous system disorders Insomnia	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	15.4% 4/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Musculoskeletal and connective tissue disorders Joint sprain	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Nervous system disorders Learning disability	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Psychiatric disorders Mood alterations with depression symptoms	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Nervous system disorders Motor tic	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Respiratory, thoracic and mediastinal disorders Nasal discharge	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Psychiatric disorders Obsessive rumination	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Psychiatric disorders Pica	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Nervous system disorders Seizure	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Gastrointestinal disorders Tooth disorder	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	7.7% 2/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Infections and infestations Upper respiratory infection	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	11.5% 3/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.
Skin and subcutaneous tissue disorders Xerosis	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	3.8% 1/26 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.	— 0/0 • Up to 9 weeks Adverse Event information was not collected on caregivers or staff.