NCT04293627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

February 27, 2020

Last Update Submit

March 10, 2022

Conditions

Autism Spectrum DisorderMental Health Issue

Keywords

pediatric primary careimplementation scienceco-occurring mental health conditionscommunity academic partnership

Outcome Measures

Primary Outcomes (5)

  • Feasibility and acceptability of ATTAIN

    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."

    Post-pilot (4 months of ATTAIN delivery)

  • Acceptability of Intervention Measure

    A 4-item measure to assess the extent to which providers/staff believe ATTAIN is acceptable.

    Post-pilot (4 months of ATTAIN delivery)

  • Feasibility of Intervention Measure

    A 4-item measure to assess the extent to which providers/staff believe ATTAIN is feasible.

    Post-pilot (4 months of ATTAIN delivery)

  • ASD + Mental Health Comfort and Knowledge Questionnaire

    A questionnaire adapted from autism implementation studies (Brookman-Frazee et al., 2019; Stadnick et al., 2020) assessing provider perceptions of comfort and knowledge about serving children with ASD.

    Post-pilot (4 months of ATTAIN delivery)

  • Measure of Innovation-Specific Implementation Intentions (MISII)

    A 3-item measure assessing provider intentions to use a specific innovation (ATTAIN).

    Post-pilot (4 months of ATTAIN delivery)

Secondary Outcomes (1)

  • ATTAIN Uptake

    Post-pilot (4 months of ATTAIN delivery)

Interventions

ATTAINBEHAVIORAL

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

Age4 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (4)

  • 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.

    PMID: 30976456BACKGROUND

  • 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.

    PMID: 31311287BACKGROUND

  • 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.

    PMID: 32205263BACKGROUND

  • 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.

    PMID: 32686469BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Nicole A Stadnick, PhD, MPH

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 3, 2020

Study Start

November 13, 2019

Primary Completion

October 31, 2021

Study Completion

March 10, 2022

Last Updated

March 28, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Researchers may contact the PI to request de-identified data in aggregate form, as appropriate.

Locations

US(1)