Autism Spectrum DisorderNCT06651086
Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services
A study testing Unstuck and On Target and Unified Protocol for Children in people with Autism Spectrum Disorder and Executive Functioning, run by San Diego State University at 2 sites in United States.
Trial summary
This project aims to follow up on a prior project examining the impact of training therapists in an executive functioning intervention Unstuck and On Target (UOT) adapted for community mental health settings. Read more about this study
- Who is it for?
- Ages 6 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Executive Functioning
- What is being tested?
- Unstuck and On Target and Unified Protocol for Children
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 672 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Dec 2024to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mental Health Programs:
- Publicly-funded
- Providing outpatient or school-based psychotherapy services to children
- Have at least 8 mental health providers on staff
- Therapists:
- Employed as staff or trainee at a participating program
Show all 18Show fewer
- Employed at the program for at least the next 12 months
- Providing psychotherapy services to children
- Has an eligible child on current caseload (see below)
- Autistic Child/Caregiver Participants (enrolled in a dyad with a participating therapist):
- Child age 6-12 years
- Receiving services from an enrolled therapist
- Documented or suspected* autism diagnosis
- In the event of suspected autism diagnosis, the presence of elevated autism symptoms on the Social Responsiveness Scale-2nd Edition or the Autism Diagnostic Observation Scale-2nd Edition
- Non-Autistic Child/Caregiver Participants (enrolled in a dyad with a participating therapist):
- Child age 6-12 years
- Receiving services from an enrolled provider
- No history of documented or suspected autism diagnosis
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hannah E Reynolds, MPH contact
United States2 sites, 2 recruiting
- Recruiting
University of Colorado - Anschutz
Aurora, Colorado, 80045
Sarah Kennedy, PhD, 720-777-1234, sarah.kennedy@cuanschutz.edu
Hannah E Reynolds, MPH, hreynolds@sdsu.edu
- Recruiting
San Diego State University
San Diego, California, 92182
Kelsey S Dickson, PhD, 858-966-7703 ext. ext 246907, kdickson@sdsu.edu
Hannah E Reynolds, MPH, hreynolds@sdsu.edu
About this study
This project aims to follow up on a prior project examining the impact of training therapists in an executive functioning intervention Unstuck and On Target (UOT) adapted for community mental health settings. Study aims are to test the clinical and implementation effectiveness of training mental health therapists in Unstuck and On Target, an executive functioning intervention, relative to Unified Protocol for Children, a transdiagnostic intervention for emotional disorders. This includes examining the implementation of Unstuck and associated outcomes (e.g., effective delivery, expanded use of Unstuck beyond autism, the feasibility of Unstuck) and impact on changes in child executive functioning and behaviors.
Read the detailed description
Autism is a highly prevalent neurodevelopmental condition, affecting 1 in 36 youth. The annual cost in the U.S. of autism was $223 billion in 2020 and is estimated to rise to $589 billion by 2030. Outcomes are poor and care disparities and high rates of unmet service needs are common. Mental health services play a key role in caring for autistic youth. There have been efforts to develop evidence-based interventions (EBIs) with the potential to lessen the public health burden of autism. Yet, research indicates limited community EBI penetration. Several work gaps remain, including a focus on EBIs designed for community implementation and those addressing multilevel barriers impeding EBI use. There is an urgent need to focus on EBIs that improve mental health services for autism and optimize outcomes for this priority, complex population. Executive functioning (EF) is a potent mechanism underlying autism and commonly co-occurring mental health conditions. EF impairments (e.g., inflexibility, poor goal setting, poor planning) contribute to negative outcomes spanning multiple areas (e.g., academic, vocational, health). Our work underscores the impact of EF deficits on mental health services, including its transdiagnostic impact on the majority of children served in this setting and its role as a barrier to psychotherapy engagement and progress. EF is responsive to treatment, and mental health therapists cite a significant need and motivation for EF treatments, making EF EBIs highly relevant for community mental health settings. However, EF EBIs have not been widely used and tested in such settings. Autism EBIs, or those developed or adapted for autistic youth, have the potential to enhance mental health services, in addition to improving service quality for the populations targeted (e.g., autism). This is due to the specific components and strategies incorporated into the EBI to enhance its impact and fit. We propose a Hybrid Type 2 randomized trial examining the effectiveness and implementation of an autism EF EBI (Unstuck and On Target) in community mental health settings. Unstuck and On Target is a cognitive-behavioral EF intervention effective for autism.
With NIMH funding (K23MH115100;), Unstuck and On Target were systematically adapted for and tested in mental health settings, with a pilot test suggesting its preliminary effectiveness, high fidelity, and use beyond autism. Findings have the potential to transform implementation and service quality for the high-priority population of autistic youth as well as youth generally. Aim 1. Evaluate the effectiveness and implementation of an autism EBI (Unstuck and On Target), relative to a non-autism transdiagnostic intervention (Unified Protocol for Children) for autistic youth. Aim 2. Evaluate mediators of EBI training effects to confirm engaged change mechanisms of clinical and implementation outcomes. Aim 3. Explore the generalized effects of EBI training on reach and improved psychotherapy quality with non-autistic youth.
- Conditions
- Autism Spectrum Disorder, Executive Functioning
- Being tested
- Unstuck and On Target, Unified Protocol for Children
- Keywords
- Autism spectrum disorder, executive functioning, emotion regulation, mental health symptoms, Unified Protcol for Children, Unstuck and On Target, evidence based intervention
- Medical subject headings
- Autism Spectrum Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unstuck and On TargetBehavioural
Unstuck and on Target (Unstuck; Cannon et al., 2021) is a cognitive-behavioral, intervention designed to be feasibly delivered by teachers and school staff in the elementary school setting. It was adapted for and pilot-tested in outpatient mental health. Unstuck targets key executive functions, including flexibility, goal-setting, planning, and coping. Sessions include prescribed content and activities to facilitate guided practice and home extension activities to aid generalization beyond the therapeutic session. It includes both child- and caregiver-directed strategies. It has been shown effective for youth with autism and attention-deficit/hyperactivity disorder.
Unified Protocol for ChildrenBehavioural
Unified Protocol for Children is a transdiagnostic, cognitive-behaviorally based treatment targeting shared core dysfunctions underlying emotional disorders, including distress intolerance and emotional dysregulation. It was developed by integrating cognitive-behavioral and mindfulness strategies and includes prescribed activities, in-vivo experiments, and home-extension components to promote generalization. It includes both child- and caregiver-directed strategies. In addition to its effectiveness for youth with emotional disorders, recent work supports its efficacy for youth with additional non-emotional disorders (e.g., externalizing challenges, irritability).
| Study group | Role | What they receive |
|---|---|---|
| Unstuck and On Target | Active comparator | Unstuck and on Target (Unstuck; Cannon et al., 2021) is a cognitive-behavioral, intervention designed to be feasibly delivered by teachers and school staff in the elementary school setting. It was adapted for and pilot-tested in outpatient mental health. Unstuck targets key executive functions, including flexibility, goal-setting, planning, and coping. Sessions include prescribed content and activities to facilitate guided practice and home extension activities to aid generalization beyond the therapeutic session. It includes both child- and caregiver-directed strategies. It has been shown effective for youth with autism and attention-deficit/hyperactivity disorder. Receives: Behavioral: Unstuck and On Target |
| Unified Protocol for Children | Active comparator | Unified Protocol for Children is a transdiagnostic, cognitive-behaviorally based treatment targeting shared core dysfunctions underlying emotional disorders, including distress intolerance and emotional dysregulation. It was developed by integrating cognitive-behavioral and mindfulness strategies and includes prescribed activities, in-vivo experiments, and home-extension components to promote generalization. It includes both child- and caregiver-directed strategies. In addition to its effectiveness for youth with emotional disorders, recent work supports its efficacy for youth with additional non-emotional disorders (e.g., externalizing challenges, irritability). Receives: Behavioral: Unified Protocol for Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Child Mental Health Symptoms
Changes in mental health symptoms will be measured by the Child Behavior Checklist (CBCL), a 113-item rating scale measuring a range of mental health symptoms.
Measured: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
Externalizing Behaviors
Primary outcome measures include externalizing behaviors. The Eyberg Child Behavior Inventory (ECBI), a 36-item widely used rating scale, will measure these behaviors.
Measured: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
Evidence-based Intervention Fidelity
A trained observer masked to evidence-based intervention (EBI) condition and time will assess EBI delivery during recorded sessions of participating therapist-client dyads. Unique fidelity forms with items corresponding to each EBI (Unstuck and On Target and Unified Protocol for Children) will be used. Items rate adherence (i.e., the degree to which key components are delivered as intended) and competence (responsiveness, engagement, skill). Items are rated on a 1-5 scale, with higher scores indicating better fidelity. Measures have internal consistencies and are shown to be sensitive to treatment effects.
Measured: During 6-month EBI implementation
Evidence-Based Intervention Training Engagement
Therapist evidence-based intervention (EBI) training engagement will be operationalized as adherence to training requirements, including participation in training/consultation (as rated by trainers) and training-related submissions (forms, materials).
Measured: 6-months post-EBI implementation
Secondary outcomes (2)
Evidence-Based Intervention Reach
Therapists will report on evidence-based intervention (EBI) reach as operationalized by the number and types of clients (e.g., presenting problem, diagnostic profile) of clients treated with EBI, including specific components used. Measure was adapted from prior work and used in the PI's feasibility trial.
Measured: 6-months post-EBI implementation, 12-month follow-up after EBI implementation, 18-month follow-up after EBI implementation
Psychotherapy Quality
Therapists will complete the Evidence-Based Practice Concordant Care Assessment-Therapist Report (ECCA). With funding from NIMH (R01MH100134; PI: Brookman-Frazee/Lau), ECCA was developed and validated as a pragmatic measure of evidence-based strategy delivery in psychotherapy sessions useful in indexing mental health quality of care. It has internal consistency and inter-rater reliability. Therapists will complete weekly regarding strategies within a given session with a participating client.
Measured: 6-months post-EBI implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start15 Dec 2024
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating mental health programs from California and Colorado will be randomized to one of two conditions: Unstuck and On Target training and Unified Protocol for Children training. Therapists will be recruited from each participating program and enrolled as a dyad with target children. Autistic children will be enrolled at the beginning of therapist participation and before intervention training. Non-autistic children will be enrolled after intervention training and implementation or approximately 6 months after therapist enrollment. Participating therapists and child clients served in those programs will receive the same condition as their enrolled program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 672 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, San Diego, University of Colorado, Denver
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651086
- Sponsor's protocol ID
- HS-2024-0105
- Other IDs
- R01MH137179
- Status last verified
- Apr 2026
- First submitted
- 9 Oct 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentitifed data will be shared with NDA
Publications
Dickson KS, Galligan M, Holt T, Kenworthy L, Anthony L, Roesch S, Brookman-Frazee L. Randomized Feasibility Pilot of an Executive Functioning Intervention Adapted for Children's Mental Health Settings. J Autism Dev Disord. 2025 Jul;55(7):2407-2421. doi: 10.1007/s10803-024-06365-8. Epub 2024 Apr 28.
PubMed 38678517Dickson KS, Aarons GA, Anthony LG, Kenworthy L, Crandal BR, Williams K, Brookman-Frazee L. Adaption and pilot implementation of an autism executive functioning intervention in children's mental health services: a mixed-methods study protocol. Pilot Feasibility Stud. 2020 Apr 27;6:55. doi: 10.1186/s40814-020-00593-2. eCollection 2020.
PubMed 32699642Dickson KS, Kennedy SM, Safer J, Brookman-Frazee L, Roesch S, Anthony LG. Study protocol for a hybrid type 2 effectiveness-implementation trial of two interventions for autistic and non-autistic youth in children's mental health settings: one tailored for neurodivergence and one universal. Implement Sci Commun. 2025 Nov 26;6(1):131. doi: 10.1186/s43058-025-00799-6.
PubMed 41299783
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services
- ClinicalTrials.gov ID
- NCT06651086
- Acronym / sponsor ID
- HS-2024-0105
- Conditions
- Autism Spectrum Disorder, Executive Functioning
- Keywords
- Autism spectrum disorder, executive functioning, emotion regulation, mental health symptoms, Unified Protcol for Children, Unstuck and On Target, evidence based intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 672 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, San Diego, University of Colorado, Denver
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to follow up on a prior project examining the impact of training therapists in an executive functioning intervention Unstuck and On Target (UOT) adapted for community mental health settings. Study aims are to test the clinical and implementation effectiveness of training mental health therapists in Unstuck and On Target, an executive functioning intervention, relative to Unified Protocol for Children, a transdiagnostic intervention for emotional disorders. This includes examining the implementation of Unstuck and associated outcomes (e.g., effective delivery, expanded use of Unstuck beyond autism, the feasibility of Unstuck) and impact on changes in child executive functioning and behaviors.
Detailed description
Autism is a highly prevalent neurodevelopmental condition, affecting 1 in 36 youth. The annual cost in the U.S. of autism was $223 billion in 2020 and is estimated to rise to $589 billion by 2030. Outcomes are poor and care disparities and high rates of unmet service needs are common. Mental health services play a key role in caring for autistic youth. There have been efforts to develop evidence-based interventions (EBIs) with the potential to lessen the public health burden of autism. Yet, research indicates limited community EBI penetration. Several work gaps remain, including a focus on EBIs designed for community implementation and those addressing multilevel barriers impeding EBI use. There is an urgent need to focus on EBIs that improve mental health services for autism and optimize outcomes for this priority, complex population. Executive functioning (EF) is a potent mechanism underlying autism and commonly co-occurring mental health conditions. EF impairments (e.g., inflexibility, poor goal setting, poor planning) contribute to negative outcomes spanning multiple areas (e.g., academic, vocational, health). Our work underscores the impact of EF deficits on mental health services, including its transdiagnostic impact on the majority of children served in this setting and its role as a barrier to psychotherapy engagement and progress. EF is responsive to treatment, and mental health therapists cite a significant need and motivation for EF treatments, making EF EBIs highly relevant for community mental health settings. However, EF EBIs have not been widely used and tested in such settings. Autism EBIs, or those developed or adapted for autistic youth, have the potential to enhance mental health services, in addition to improving service quality for the populations targeted (e.g., autism). This is due to the specific components and strategies incorporated into the EBI to enhance its impact and fit. We propose a Hybrid Type 2 randomized trial examining the effectiveness and implementation of an autism EF EBI (Unstuck and On Target) in community mental health settings. Unstuck and On Target is a cognitive-behavioral EF intervention effective for autism.
With NIMH funding (K23MH115100;), Unstuck and On Target were systematically adapted for and tested in mental health settings, with a pilot test suggesting its preliminary effectiveness, high fidelity, and use beyond autism. Findings have the potential to transform implementation and service quality for the high-priority population of autistic youth as well as youth generally. Aim 1. Evaluate the effectiveness and implementation of an autism EBI (Unstuck and On Target), relative to a non-autism transdiagnostic intervention (Unified Protocol for Children) for autistic youth. Aim 2. Evaluate mediators of EBI training effects to confirm engaged change mechanisms of clinical and implementation outcomes. Aim 3. Explore the generalized effects of EBI training on reach and improved psychotherapy quality with non-autistic youth.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participating mental health programs from California and Colorado will be randomized to one of two conditions: Unstuck and On Target training and Unified Protocol for Children training. Therapists will be recruited from each participating program and enrolled as a dyad with target children. Autistic children will be enrolled at the beginning of therapist participation and before intervention training. Non-autistic children will be enrolled after intervention training and implementation or approximately 6 months after therapist enrollment. Participating therapists and child clients served in those programs will receive the same condition as their enrolled program.
| Arm | Type | Receives |
|---|---|---|
| Unstuck and On Target | Active comparator | Behavioral: Unstuck and On TargetUnstuck and on Target (Unstuck; Cannon et al., 2021) is a cognitive-behavioral, intervention designed to be feasibly delivered by teachers and school staff in the elementary school setting. It was adapted for and pilot-tested in outpatient mental health. Unstuck targets key executive functions, including flexibility, goal-setting, planning, and coping. Sessions include prescribed content and activities to facilitate guided practice and home extension activities to aid generalization beyond the therapeutic session. It includes both child- and caregiver-directed strategies. It has been shown effective for youth with autism and attention-deficit/hyperactivity disorder. |
| Unified Protocol for Children | Active comparator | Behavioral: Unified Protocol for ChildrenUnified Protocol for Children is a transdiagnostic, cognitive-behaviorally based treatment targeting shared core dysfunctions underlying emotional disorders, including distress intolerance and emotional dysregulation. It was developed by integrating cognitive-behavioral and mindfulness strategies and includes prescribed activities, in-vivo experiments, and home-extension components to promote generalization. It includes both child- and caregiver-directed strategies. In addition to its effectiveness for youth with emotional disorders, recent work supports its efficacy for youth with additional non-emotional disorders (e.g., externalizing challenges, irritability). |
Who may qualify
- Ages
- 6 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Publicly-funded
- Providing outpatient or school-based psychotherapy services to children
- Have at least 8 mental health providers on staff
- Employed as staff or trainee at a participating program
- Employed at the program for at least the next 12 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Unstuck and On TargetUnstuck and on Target (Unstuck; Cannon et al., 2021) is a cognitive-behavioral, intervention designed to be feasibly delivered by teachers and school staff in the elementary school setting. It was adapted for and pilot-tested in outpatient mental health. Unstuck targets key executive functions, including flexibility, goal-setting, planning, and coping. Sessions include prescribed content and activities to facilitate guided practice and home extension activities to aid generalization beyond the therapeutic session. It includes both child- and caregiver-directed strategies. It has been shown effective for youth with autism and attention-deficit/hyperactivity disorder. | Behavioural | Unstuck and On Target |
| Unified Protocol for ChildrenUnified Protocol for Children is a transdiagnostic, cognitive-behaviorally based treatment targeting shared core dysfunctions underlying emotional disorders, including distress intolerance and emotional dysregulation. It was developed by integrating cognitive-behavioral and mindfulness strategies and includes prescribed activities, in-vivo experiments, and home-extension components to promote generalization. It includes both child- and caregiver-directed strategies. In addition to its effectiveness for youth with emotional disorders, recent work supports its efficacy for youth with additional non-emotional disorders (e.g., externalizing challenges, irritability). | Behavioural | Unified Protocol for Children |
Primary outcome
Changes in Child Mental Health Symptoms
Time frame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
Changes in mental health symptoms will be measured by the Child Behavior Checklist (CBCL), a 113-item rating scale measuring a range of mental health symptoms.
Externalizing Behaviors
Time frame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
Primary outcome measures include externalizing behaviors. The Eyberg Child Behavior Inventory (ECBI), a 36-item widely used rating scale, will measure these behaviors.
Evidence-based Intervention Fidelity
Time frame: During 6-month EBI implementation
A trained observer masked to evidence-based intervention (EBI) condition and time will assess EBI delivery during recorded sessions of participating therapist-client dyads. Unique fidelity forms with items corresponding to each EBI (Unstuck and On Target and Unified Protocol for Children) will be used. Items rate adherence (i.e., the degree to which key components are delivered as intended) and competence (responsiveness, engagement, skill). Items are rated on a 1-5 scale, with higher scores indicating better fidelity. Measures have internal consistencies and are shown to be sensitive to treatment effects.
Evidence-Based Intervention Training Engagement
Time frame: 6-months post-EBI implementation
Therapist evidence-based intervention (EBI) training engagement will be operationalized as adherence to training requirements, including participation in training/consultation (as rated by trainers) and training-related submissions (forms, materials).
2 secondary outcomes
Evidence-Based Intervention Reach
Time frame: 6-months post-EBI implementation, 12-month follow-up after EBI implementation, 18-month follow-up after EBI implementation
Psychotherapy Quality
Time frame: 6-months post-EBI implementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 38678517Dickson KS, Galligan M, Holt T, Kenworthy L, Anthony L, Roesch S, Brookman-Frazee L. Randomized Feasibility Pilot of an Executive Functioning Intervention Adapted for Children's Mental Health Settings. J Autism Dev Disord. 2025 Jul;55(7):2407-2421. doi: 10.1007/s10803-024-06365-8. Epub 2024 Apr 28.
- Background: PubMed 32699642Dickson KS, Aarons GA, Anthony LG, Kenworthy L, Crandal BR, Williams K, Brookman-Frazee L. Adaption and pilot implementation of an autism executive functioning intervention in children's mental health services: a mixed-methods study protocol. Pilot Feasibility Stud. 2020 Apr 27;6:55. doi: 10.1186/s40814-020-00593-2. eCollection 2020.
- Derived from this study: PubMed 41299783Dickson KS, Kennedy SM, Safer J, Brookman-Frazee L, Roesch S, Anthony LG. Study protocol for a hybrid type 2 effectiveness-implementation trial of two interventions for autistic and non-autistic youth in children's mental health settings: one tailored for neurodivergence and one universal. Implement Sci Commun. 2025 Nov 26;6(1):131. doi: 10.1186/s43058-025-00799-6.
- Individual participant dataSharing planned: Yes. Deidentitifed data will be shared with NDA
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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.
Hannah E Reynolds, MPH contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unstuck and On Target and Unified Protocol for Children in people with Autism Spectrum Disorder and Executive Functioning, run by San Diego State University at 2 sites 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 18 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey S Dickson, PhD (858-966-7703 ext. 246907, kdickson@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Child Mental Health Symptoms (time frame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06651086, which also lists 3 linked publications.
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 20 Apr 2026.