Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
36 participants
OBSERVATIONAL
2019-11-13
2022-03-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Adaptation and Implementation of an ASD Executive Functioning Intervention in Children's Mental Health Services
NCT04295512
Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services
NCT06651086
Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial
NCT00789932
Autism and Disruptive Behavior Trial
NCT04204226
Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism
NCT05344378
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Phase 3. Conduct an open trial feasibility pilot test of ATTAIN (directly informed by adaptations identified earlier in the larger study) in pediatric primary care.
Participants
Providers: A total of 45 pediatric care providers and staff will be recruited for enrollment from primary care practices in the region. This targeted sample size was chosen based on sample sizes used within completed pilot studies focused on service interventions in pediatric care. Each provider and healthcare staff member will be asked to use or support use of ATTAIN with up to 5 eligible patients over four months.
Families: Eligible pediatric patients must be: 1) English and/or Spanish-speaking, 2) between 4-16 years of age and 3) have a documented ASD diagnosis in the electronic health record. After four months of ATTAIN use by their child's primary care provider, caregivers will be contacted by the research team to be invited to complete an online survey about their child's healthcare experiences over the past four months.
Procedure Leadership at each primary care organization will be approached about their primary care practices participating in the pilot study. Primary care practices within each organization will be purposively selected for targeted recruitment of providers for ATTAIN implementation based on volume of patients with ASD. Members of the research team will request an invitation to present at regularly scheduled staff meetings to recruit primary care providers. Interested providers will be asked to complete a study interest form and indicate preferred times to attend a group meeting to review study participation details, the Study Information Sheet, and receive training in using the ATTAIN model. For some clinics, leadership may prefer that the recruitment and training be conducted during the same meeting for the purpose of reducing staff burden. At these meetings, the research team will provide a meal and refreshments. Subsequently, trained providers will be asked to use ATTAIN with up to 5 eligible patients during any outpatient appointment (e.g., annual check-ups, drop-in appointments) to maximize early detection of mental health problems and opportunity to link to mental health services. Throughout the 4 months, we may ask providers and supporting staff to elaborate on their experiences using ATTAIN via e-mail or phone-call to understand challenges to implementation, recommendations for improving implementation or adaptations in implementing the ATTAIN model in their clinic. Time to complete these brief reflections will take no more than 5-10 minutes each. Quantitative data of ATTAIN use will be extracted from patient charts and de-identified data will be sent to the research team during the four month study period and at the end of 4 months. After 4 months of ATTAIN delivery, participating providers and caregivers of youth with ASD with whom providers used ATTAIN will be asked to complete a brief online survey regarding their experiences using ATTAIN. Providers and staff will be asked to attend a meeting, where food and light refreshments will be provided, to complete the survey. In addition, providers and staff will be invited to participate in a post-study interview that will be offered to be completed by phone or in-person. Caregivers will receive $20 for survey completion. The ATTAIN model was developed to be embedded within routine primary care settings and workflow so there are minimal risks to primary care providers, caregivers or children associated with participation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ATTAIN
ATTAIN is an 8-step model to identify co-occurring mental health conditions and facilitate linkage to mental health services for youth with an existing autism spectrum disorder diagnosis.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
4 Years
16 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kaiser Permanente
OTHER
San Ysidro Health Center
OTHER
Rady Children's Hospital, San Diego
OTHER
University of California, San Diego
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nicole Stadnick
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicole A Stadnick, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Diego
La Jolla, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Stadnick NA, Brookman-Frazee L, Mandell DS, Kuelbs CL, Coleman KJ, Sahms T, Aarons GA. A mixed methods study to adapt and implement integrated mental healthcare for children with autism spectrum disorder. Pilot Feasibility Stud. 2019 Mar 28;5:51. doi: 10.1186/s40814-019-0434-5. eCollection 2019.
Broder-Fingert S, Stadnick NA, Hickey E, Goupil J, Diaz Lindhart Y, Feinberg E. Defining the core components of Family Navigation for autism spectrum disorder. Autism. 2020 Feb;24(2):526-530. doi: 10.1177/1362361319864079. Epub 2019 Jul 16.
Stadnick NA, Martinez K, Aarons GA, Lee DA, Van Cleave J, Brookman-Frazee L. Pediatric Primary Care Perspectives on Integrated Mental Health Care for Autism. Acad Pediatr. 2020 Nov-Dec;20(8):1140-1147. doi: 10.1016/j.acap.2020.03.006. Epub 2020 Mar 20.
Stadnick NA, Lau AS, Dickson KS, Pesanti K, Innes-Gomberg D, Brookman-Frazee L. Service use by youth with autism within a system-driven implementation of evidence-based practices in children's mental health services. Autism. 2020 Nov;24(8):2094-2103. doi: 10.1177/1362361320934230. Epub 2020 Jul 18.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UC San Diego
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.