Access to Tailored Autism Integrated Care Pilot Study (ATTAIN)

• ClinicalTrials.gov Identifier: NCT04293627
• Recruitment Status: Recruiting
• First Posted: March 3, 2020
• Last Update Posted: March 3, 2020
• Sponsor: University of California, San Diego
• Collaborators: Kaiser Permanente; San Ysidro Health Center; Rady Children's Hospital, San Diego
• Information provided by (Responsible Party): Nicole Stadnick, University of California, San Diego

Study Description

Brief Summary:

Children with autism spectrum disorder (ASD) represent a rapidly growing, high-priority clinical population highlighted by the NIMH and Interagency Autism Coordinating Committee due, in part, because they have multiple service needs including access to effective mental health treatment given high rates of psychiatric comorbidities. Pediatric primary care is a critical and ongoing point of health care access for children with ASD and thus represents an ideal setting for identification of mental health service needs and appropriate linkage to care. The proposed study will use implementation science theory and methods and a research-community partnership approach to: 1) identify targets to improve mental health screening and linkage to mental health services in primary care for children with ASD, 2) adapt integrated care procedures into "Access To Tailored Autism INtegrated Care," ATTAIN, to facilitate identification of mental health problems and linkage to evidence-based care for youth with ASD, and 3) conduct an open trial feasibility pilot test of ATTAIN in pediatric primary care.

Condition or disease	Intervention/treatment
Autism Spectrum Disorder; Mental Health Issue	Behavioral: ATTAIN

Detailed Description:

This description is focused solely on the feasibility pilot test of ATTAIN in pediatric primary care.

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 45 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Official Title: ADAPTING AND IMPLEMENTING AN INTEGRATED CARE MODEL FOR YOUTH WITH AUTISM SPECTRUM DISORDER AND PSYCHIATRIC COMORBIDITY
• Actual Study Start Date: November 13, 2019
• Estimated Primary Completion Date: June 2020
• Estimated Study Completion Date: December 2020

Groups and Cohorts

Intervention Details:

• Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility and acceptability of ATTAIN [ Time Frame: Post-pilot (4 months of ATTAIN delivery) ]
   The Perceived Characteristics of Intervention Scale (PCIS) will be used to examine providers' and staff's perspectives regarding feasibility and acceptability of ATTAIN. The PCIS is a 20-item scale that assesses attitudes towards a specific intervention including relative advantage, compatibility, and complexity. Participants are asked to rate the extent to which they agree with each item on a 5-point Likert scale. Example items include, "The ATTAIN model is clear and understandable" and "Using the ATTAIN model fits well with the way I like to work."
2. Acceptability of Intervention Measure [ Time Frame: Post-pilot (4 months of ATTAIN delivery) ]
   A 4-item measure to assess the extent to which providers/staff believe ATTAIN is acceptable.
3. Intervention Appropriateness Measure [ Time Frame: Post-pilot (4 months of ATTAIN delivery) ]
   A 4-item measure to assess the extent to which providers/staff believe ATTAIN is appropriate.
4. Feasibility of Intervention Measure [ Time Frame: Post-pilot (4 months of ATTAIN delivery) ]
   A 4-item measure to assess the extent to which providers/staff believe ATTAIN is feasible.
5. ASD + Mental Health Comfort and Knowledge Questionnaire [ Time Frame: Post-pilot (4 months of ATTAIN delivery) ]
   A 15-item questionnaire adapted from AIM HI (Brookman-Frazee, Drahota, & Stadnick, 2012) and Phase I of the current study assessing provider perceptions of comfort and knowledge about serving children with ASD.
6. Measurement of Inner Context Sustainment (MICS) [ Time Frame: Post-pilot (4 months of ATTAIN delivery) ]
   A a 22-item scale assessing perceptions of the extent to which ATTAIN use is sustained over time.

Secondary Outcome Measures :

1. ATTAIN Uptake [ Time Frame: Post-pilot (4 months of ATTAIN delivery) ]
   ATTAIN uptake will be measured using extracted data from the electronic health record system or provider-reported data about the number of patients with whom they used ATTAIN. Specifically, uptake will be defined as the proportion of ATTAIN-eligible patients (i.e., children with a documented ASD diagnosis) to the number children with whom providers used ATTAIN.
2. Caregiver Perceptions of Mental Health Care Connection [ Time Frame: Post-pilot (4 months of ATTAIN delivery) ]
   Caregivers will be asked to complete a brief online survey inquiring about their experiences engaged in the ATTAIN model.

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Providers and families will be recruited from pre-identified pediatric primary care clinics in Southern California serving children with autism spectrum disorder.

Criteria

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.

Contacts and Locations

Contacts

Contact: Nicole A Stadnick, PhD, MPH; 858-966-7703 ext 247101; nstadnic@health.ucsd.edu

Contact: Joanna Sarinana, BS; 858-966-7703 ext 243628; jlsarinana@health.ucsd.edu

Locations

United States, California

University of California, San Diego; Recruiting

La Jolla, California, United States, 92093

Contact: Nicole A Stadnick, PhD, MPH 858-966-7703 ext 247101 nstadnic@health.ucsd.edu

Sponsors and Collaborators

University of California, San Diego

Kaiser Permanente

San Ysidro Health Center

Rady Children's Hospital, San Diego

Investigators

• Principal Investigator: Nicole A Stadnick, PhD, MPH; Assistant Professor

More Information

Publications:

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.

• Responsible Party: Nicole Stadnick, Assistant Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT04293627
• Other Study ID Numbers: UC San Diego
• First Posted: March 3, 2020
• Last Update Posted: March 3, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Researchers may contact the PI to request de-identified data in aggregate form, as appropriate.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nicole Stadnick, University of California, San Diego:

pediatric primary care; implementation science; co-occurring mental health conditions; community academic partnership

Additional relevant MeSH terms:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders