Autism Spectrum DisorderAIM HINCT02416323
Effectiveness and Implementation of a Mental Health Intervention for ASD
A study testing AIM HI Training in people with Autism Spectrum Disorder, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of training community mental health therapists to deliver a mental health intervention for ASD ("AIM HI") and study the process of implementing AIM HI in community mental health programs. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- AIM HI Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 609 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Employed as staff or a trainee at participating clinic (publicly-funded mental health program)
- Employed for at least the next 7 months (i.e., practicum or internship not ending in next 7 months).
- Has an eligible client on current caseload (see below).
- Child age 5-13 years.
- Has a current ASD diagnosis on record.
- Meets criteria for ASD on the Autism Diagnostic Observation Schedule (ADOS) or exhibits other clinical indicators of ASD
- English or Spanish speaking.
Who cannot join
- Child does not present with challenging behaviors.
- Child does not meet criteria for ASD on the ADOS or exhibit other clinical indicators of ASD
Trial locations and contacts
1 site in 1 country.
United States1 site
Child and Adolescent Services Research Center
San Diego, California, 92123
About this study
The purpose of this study is to test the effectiveness of training community mental health therapists to deliver a mental health intervention for ASD ("AIM HI") and study the process of implementing AIM HI in community mental health programs.
Read the detailed description
This study is a randomized controlled effectiveness trial of AIM HI ("An Individualized Mental Health Intervention for ASD"), an intervention designed specifically for implementation in community mental health clinics, to reduce problem behavior among school-age children with autism spectrum disorders (ASD). Although the individual components of AIM HI are well-established evidence-based practice strategies and pilot study data indicate that child behavior problems decrease when their community mental health therapists deliver AIM HI, the effectiveness of the protocol has not been established. Therefore, the primary aims are to test the impact of training community therapists in AIM HI on child and family outcomes and determine how child/ family characteristics and level of therapist fidelity moderate treatment effects. The secondary aim is to collect initial data on implementation outcomes and conduct exploratory analyses to identify barriers and facilitators of AIM HI implementation (e.g., intervention, organization, provider characteristics). This study has the potential to make a significant impact by building local capacity to serve school-age children with ASD in routine service settings, and advancing the science on the effectiveness of packaging evidence-based practices (EBPs) for specific services settings. It will also produce generalizable knowledge about implementation that can be applied for this population/ setting.
- Conditions
- Autism Spectrum Disorder
- Being tested
- AIM HI Training
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIM HI TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Community therapist delivers routine care to participant child with no training in AIM HI. |
| AIM HI Training | Other | Therapist enrolls in AIM HI training Receives: Other: AIM HI Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change since baseline in child behaviors on the Eyberg Child Behavior Inventory (ECBI)
Measured: Study Enrollment, 6, 12, 18 months post study enrollment
Secondary outcomes (1)
Change since baseline in child behaviors on the Social Skills Improvement System (SSIS) Competing Behavior Scale
Measured: Study Enrollment, 6, 12, 18 months post study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2012
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lauren Brookman-Frazee, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416323
- Sponsor's protocol ID
- 2011-4131
- Other IDs
- R01MH094317
- Acronym
- AIM HI
- Status last verified
- Jul 2018
- First submitted
- 7 Apr 2015
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Caplan B, Chlebowski C, Lind T, Rangel E, Brookman-Frazee L. Therapist-Reported Adaptations to an Autism Intervention: Family-Level Predictors and Associations with Fidelity. J Autism Dev Disord. 2026 Mar;56(3):933-944. doi: 10.1007/s10803-024-06603-z. Epub 2024 Oct 28.
PubMed 39466584Caplan B, Lind T, Chlebowski C, Martinez K, May GC, Gomez Alvarado CJ, Brookman-Frazee L. Training Community Therapists in AIM HI: Individual Family and Neighborhood Factors and Child/Caregiver Outcomes. J Clin Child Adolesc Psychol. 2024 Sep-Oct;53(5):783-795. doi: 10.1080/15374416.2022.2096046. Epub 2022 Jul 26.
PubMed 35881774Brookman-Frazee L, Chlebowski C, Villodas M, Roesch S, Martinez K. Training Community Therapists to Deliver an Individualized Mental Health Intervention for Autism Spectrum Disorder: Changes in Caregiver Outcomes and Mediating Role on Child Outcomes. J Am Acad Child Adolesc Psychiatry. 2021 Mar;60(3):355-366. doi: 10.1016/j.jaac.2020.07.896. Epub 2020 Aug 2.
PubMed 32755632Brookman-Frazee L, Roesch S, Chlebowski C, Baker-Ericzen M, Ganger W. Effectiveness of Training Therapists to Deliver An Individualized Mental Health Intervention for Children With ASD in Publicly Funded Mental Health Services: A Cluster Randomized Clinical Trial. JAMA Psychiatry. 2019 Jun 1;76(6):574-583. doi: 10.1001/jamapsychiatry.2019.0011.
PubMed 30840040Stadnick N, Chlebowski C, Baker-Ericzen M, Dyson M, Garland A, Brookman-Frazee L. Psychiatric comorbidity in autism spectrum disorder: Correspondence between mental health clinician report and structured parent interview. Autism. 2017 Oct;21(7):841-851. doi: 10.1177/1362361316654083. Epub 2016 Jul 11.
PubMed 27407039
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Implementation of a Mental Health Intervention for ASD
- ClinicalTrials.gov ID
- NCT02416323
- Acronym / sponsor ID
- AIM HI / 2011-4131
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2012
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 15 Apr 2015 (estimated)
- 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.
The purpose of this study is to test the effectiveness of training community mental health therapists to deliver a mental health intervention for ASD ("AIM HI") and study the process of implementing AIM HI in community mental health programs.
Detailed description
This study is a randomized controlled effectiveness trial of AIM HI ("An Individualized Mental Health Intervention for ASD"), an intervention designed specifically for implementation in community mental health clinics, to reduce problem behavior among school-age children with autism spectrum disorders (ASD). Although the individual components of AIM HI are well-established evidence-based practice strategies and pilot study data indicate that child behavior problems decrease when their community mental health therapists deliver AIM HI, the effectiveness of the protocol has not been established. Therefore, the primary aims are to test the impact of training community therapists in AIM HI on child and family outcomes and determine how child/ family characteristics and level of therapist fidelity moderate treatment effects. The secondary aim is to collect initial data on implementation outcomes and conduct exploratory analyses to identify barriers and facilitators of AIM HI implementation (e.g., intervention, organization, provider characteristics). This study has the potential to make a significant impact by building local capacity to serve school-age children with ASD in routine service settings, and advancing the science on the effectiveness of packaging evidence-based practices (EBPs) for specific services settings. It will also produce generalizable knowledge about implementation that can be applied for this population/ setting.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Community therapist delivers routine care to participant child with no training in AIM HI. |
| AIM HI Training | Other | Other: AIM HI TrainingTherapist enrolls in AIM HI training |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Employed as staff or a trainee at participating clinic (publicly-funded mental health program)
- Employed for at least the next 7 months (i.e., practicum or internship not ending in next 7 months).
- Has an eligible client on current caseload (see below).
- Child age 5-13 years.
- Has a current ASD diagnosis on record.
Key exclusion criteria (2 listed)
- Child does not present with challenging behaviors.
- Child does not meet criteria for ASD on the ADOS or exhibit other clinical indicators of ASD
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 |
|---|---|---|
| AIM HI Training | Other | AIM HI Training |
Primary outcome
Change since baseline in child behaviors on the Eyberg Child Behavior Inventory (ECBI)
Time frame: Study Enrollment, 6, 12, 18 months post study enrollment
1 secondary outcome
Change since baseline in child behaviors on the Social Skills Improvement System (SSIS) Competing Behavior Scale
Time frame: Study Enrollment, 6, 12, 18 months post study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Derived from this study: PubMed 39466584Caplan B, Chlebowski C, Lind T, Rangel E, Brookman-Frazee L. Therapist-Reported Adaptations to an Autism Intervention: Family-Level Predictors and Associations with Fidelity. J Autism Dev Disord. 2026 Mar;56(3):933-944. doi: 10.1007/s10803-024-06603-z. Epub 2024 Oct 28.
- Derived from this study: PubMed 35881774Caplan B, Lind T, Chlebowski C, Martinez K, May GC, Gomez Alvarado CJ, Brookman-Frazee L. Training Community Therapists in AIM HI: Individual Family and Neighborhood Factors and Child/Caregiver Outcomes. J Clin Child Adolesc Psychol. 2024 Sep-Oct;53(5):783-795. doi: 10.1080/15374416.2022.2096046. Epub 2022 Jul 26.
- Derived from this study: PubMed 32755632Brookman-Frazee L, Chlebowski C, Villodas M, Roesch S, Martinez K. Training Community Therapists to Deliver an Individualized Mental Health Intervention for Autism Spectrum Disorder: Changes in Caregiver Outcomes and Mediating Role on Child Outcomes. J Am Acad Child Adolesc Psychiatry. 2021 Mar;60(3):355-366. doi: 10.1016/j.jaac.2020.07.896. Epub 2020 Aug 2.
- Derived from this study: PubMed 30840040Brookman-Frazee L, Roesch S, Chlebowski C, Baker-Ericzen M, Ganger W. Effectiveness of Training Therapists to Deliver An Individualized Mental Health Intervention for Children With ASD in Publicly Funded Mental Health Services: A Cluster Randomized Clinical Trial. JAMA Psychiatry. 2019 Jun 1;76(6):574-583. doi: 10.1001/jamapsychiatry.2019.0011.
- Derived from this study: PubMed 27407039Stadnick N, Chlebowski C, Baker-Ericzen M, Dyson M, Garland A, Brookman-Frazee L. Psychiatric comorbidity in autism spectrum disorder: Correspondence between mental health clinician report and structured parent interview. Autism. 2017 Oct;21(7):841-851. doi: 10.1177/1362361316654083. Epub 2016 Jul 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIM HI Training in people with Autism Spectrum Disorder, run by University of California, San Diego 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 7 inclusion and 2 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 9 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change since baseline in child behaviors on the Eyberg Child Behavior Inventory (ECBI) (time frame: Study Enrollment, 6, 12, 18 months post study enrollment). 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 NCT02416323, which also lists 5 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 9 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.