Clinical trial NCT04173663: Advocating for Supports to Improve Service Transitions
Official title: Project ASSIST: Advocating for Supports to Improve Service Transitions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Illinois at Urbana-Champaign
name: University of Wisconsin, Madison
First posted: 2019-11-22
Enrollment: 185
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After eligibility is determined and baseline data are collected, parents will be randomized, in two cohorts, to the treatment or materials-only control condition. Given the relatively small sample size in each cohort at each site (n = 30 at each of three sites), simple randomization is not recommended as it might result in unequal group sizes. The investigators will use 1:1 block randomization within each site to give equal number of subjects in each group. To ensure balance of important covariates, the investigators will block on key moderators: whether the youth has an Intellectual Disability (ID) and is in high school. Co-occurring ID and being in vs. out of high school impact service eligibility, and ID impacts the likelihood of post-secondary education (PSE) and community employment. By balancing moderators, the researchers maximize power to detect effect modification of the treatment effect.
Primary purpose: TREATMENT

Brief summary: This is a randomized intervention study to develop and test the national curriculum of a parent intervention training targeting parent's ability for advocate for services to improve the transition to adulthood for their youth with autism spectrum disorder (ASD).

UPDATE regarding COVID-19: Due to social distancing restrictions, the in-person intervention series that began in Winter 2020 was paused in Spring 2020 for Cohort 1 intervention groups (TN and IL). The series resumed in Summer 2020 via synchronous web-conferencing. In response to continued pandemic regulations, ASSIST was permanently moved to synchronous web-conferencing in Fall 2020, and this method was the mode of delivery for all remaining sessions and series at all sites (TN, IL, WI).

The remaining baseline data was also moved to remote collection through online interview and questionnaires in Spring 2020. The data collection for all follow ups and check ins (6, 12, 18, 24, and 30 month) were completed through web conference and/or phone calls in addition to online surveys. The final data collection for experimental and control groups from all sites will be complete by Summer 2023.

Detailed description: The proposed research plan is designed to develop and test the effectiveness of a national curriculum of the ASSIST (Advocating for SupportS to Improve Service Transition) program, a 12-week parent training program targeting parents' ability to advocate for services to improve the transition to adulthood for youth with autism (note that an optional 13th session on secondary transition planning can be offered if ASSIST is being delivered to families of youth who are in high school).

Preliminary work demonstrated that youth whose parents participated in the "Volunteer Advocacy Program- Transition" or VAP-T (a pilot 12-week intervention program on which ASSIST is based) were more likely to be employed or in postsecondary education (PSE), and received more school-based and adult services, when compared to a wait-list control group.

In the proposed research, the investigators conduct a randomized-controlled trial with 180 families to build on previous findings in four important ways: 1) by making modifications to the program content to make it applicable to service systems across the nation, and rigorously testing whether the ASSIST program is effective when delivered across three states (Tennessee, Illinois, Wisconsin); 2) by incorporating the perspective of offspring with autism into the intervention and data collection; 3) by examining mechanisms by which the ASSIST program influences youth outcomes; and 4) by exploring barriers to participation and factors that moderate treatment response.

The investigators hypothesize that ASSIST participation will improve parents' advocacy ability, leading to higher rates of employment, PSE, social participation, and service access for youth with autism. The investigators will test this hypothesis by randomly assigning parents of transition-aged youth with autism (ages 16-26) to either a treatment or active, materials-only control group, and following families over 3 years. The investigators propose four Specific Aims: (1) To use a multi-site randomized-controlled trial to examine whether ASSIST participation increases parent advocacy ability (i.e. the intervention target); (2) To test whether participating in ASSIST leads to improved youth outcomes (employment, post-secondary education, social participation, service access) during the transition to adulthood; (3) To examine which aspects of parent advocacy ability mediate the relations between ASSIST participation and youth outcomes; and (4) To explore moderators of treatment response and barriers to participation in the intervention.

By rigorously testing a new intervention to improve the transition to adulthood for youth with autism, the proposed research addresses an area of critical need as identified by the 2016-7 Interagency Autism Coordinating Committee Strategic Plan. The project will result in a new intervention to improve outcomes for youth with autism that can be disseminated through state and local agencies across the nation.

Eligibility criteria: Inclusion criteria include:

1. parents willing to participate in the ASSIST 12-week intervention, who have an offspring with autism between the ages of 16 and 26 years. This age range was chosen to allow for the testing of whether the ASSIST is more effective if offered prior to versus after high school exit (a key moderator in Aim 4). The investigators set a lower bound of age 16, as that is when transition planning is mandated to have begun in the schools, and an upper bound of age 26 to capture families of youth who are still in the "transition years" as defined by the Institute of Medicine. If both parents in a family want to attend the training, the investigators will allow it but will designate one as the study's primary respondent. There is no minimum or maximum age limit for parent participants.
2. parents are willing to be randomized to the treatment or control condition;
3. parents are able to travel weekly to one of the project sites (Nashville, TN; Chicagoland;IL; Madison/Milwaukee, WI) to participate in the group ASSIST sessions (12 weekly sessions). The responding parent and the offspring with ASD must also be able to travel to a project site for a diagnostic evaluation to confirm the ASD diagnosis (using the gold- standard Autism Diagnostic Observation Schedule-2 or ADOS-2) and to establish IQ and adaptive behavior functioning;
4. the participating parent and youth must live in one of the states where the intervention is being delivered, as the adult service system is different in every state;
5. son/daughter has a previous diagnosis of ASD from an educational or health care provider, and meets lifetime cut-offs for ASD in a telephone screening of the Social Communication Questionnaire. This will decrease the risk that youth fail to meet diagnostic criteria for ASD during the diagnostic evaluation. Note that although the investigators will collect IQ and adaptive behavior information to assess functioning of the offspring with ASD, this information will not be used to determine eligibility; parents of offspring with all levels of functioning can participate in the ASSIST project; and
6. the participating parent is proficient with the English language, as all ASSIST presentations and data collection materials are in English.

Exclusion criteria include:

1. parents unable to participate in the ASSIST 12-week intervention due to scheduling conflicts, or who are unable to travel weekly to one of the sites;
2. parents NOT willing to be randomized to the treatment or control condition;
3. parents and/or youth do NOT live in one of the states where the intervention is being delivered;
4. The youth does not have a previous diagnosis of ASD from an educational or health care provider
5. The youth does not meet lifetime cut-offs for ASD in a telephone screening of the Social Communication Questionnaire, answered by the parent.
6. The participating parent is not proficient with the English language.

Primary outcomes:
measure: Treatment Target: Change in Parental Empowerment Scale
timeFrame: Baseline to intervention-end, up to month 10
measure: Treatment Target: Change in Parental Knowledge About Adult Services Questionnaire
timeFrame: Baseline to intervention-end, up to month 10
measure: Treatment Target: Change in Advocacy Skills and Comfort Scale
timeFrame: Baseline to intervention-end, up to month 10
measure: Change in Advocacy Activities Scale
timeFrame: Baseline to 12-month post-intervention, up to month 21
measure: Change in Access to Services Interview: Number of Services the Family Applied for
timeFrame: Baseline to 6-month post-intervention, up to month 15; Baseline to 12-month post-intervention, up to month 21
measure: Change in Access to Services Interview: Number of Services the Family is Receiving
timeFrame: Baseline to 6-month post-intervention, up to month 15; Baseline to 12-month post-intervention, up to month 21
measure: Post-Secondary Youth Outcomes
timeFrame: Baseline to 6-month post-intervention, up to month 15; Baseline to 12-month post-intervention, up to month 21
Secondary outcomes:
measure: Social Participation Youth Outcomes
timeFrame: Baseline to 12-month post-intervention, up to month 21
measure: Change in Access to Services Interview: Unmet Service Needs
timeFrame: Baseline to 6-month post-intervention, up to month 15; Baseline to 12-month post-intervention, up to month 21
measure: Access to Services Interview: Barriers to Service Receipt
timeFrame: Baseline to 12-month post-intervention, up to month 21
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Madison
country: United States
facility: Waisman Center at University of Madison-Wisconsin
state: Wisconsin
Study officials:
affiliation: Vanderbilt University Medical Center
name: Julie Lounds Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burke,MM, Goldman SE, Hart MS, Hodapp RM. Evaluating the Efficacy of a Special Education Advocacy Training Program: Evaluating the Efficacy of Advocacy Training. Journal of Policy and Practice in Intellectual Disabilities, 13(4), 269-276, 2016.
citation: Koren PE, DeChillo N, Friesen, BJ. Measuring empowerment in families whose children have emotional disabilities: A brief questionnaire. Rehabilitation Psychology, 37(4), 305-321, 1992.
citation: Sanford C, Newman L, Wagner M, Cameto R, Knokey AM, Shaver D. The Post-High School Outcomes of Young Adults with Disabilities up to 6 Years after High School: Key Findings from the National Longitudinal Transition Study-2 (NLTS2). NCSER 2011-3004. National Center for Special Education Research, 2011.
citation: Lounds Taylor J, Adams RE, Bishop SL. Social participation and its relation to internalizing symptoms among youth with autism spectrum disorder as they transition from high school. Autism Res. 2017 Apr;10(4):663-672. doi: 10.1002/aur.1709. Epub 2016 Oct 14.
citation: Taylor JL, Seltzer MM. Developing a vocational index for adults with autism spectrum disorders. J Autism Dev Disord. 2012 Dec;42(12):2669-79. doi: 10.1007/s10803-012-1524-x.
citation: Taylor JL, Hodapp RM, Burke MM, Waitz-Kudla SN, Rabideau C. Training Parents of Youth with Autism Spectrum Disorder to Advocate for Adult Disability Services: Results from a Pilot Randomized Controlled Trial. J Autism Dev Disord. 2017 Mar;47(3):846-857. doi: 10.1007/s10803-016-2994-z.
citation: Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
citation: Taylor JL, Pezzimenti F, Burke MM, DaWalt LS, Lee CE, Rabideau C. Development, Feasibility, and Acceptability of a Nationally Relevant Parent Training to Improve Service Access During the Transition to Adulthood for Youth with ASD. J Autism Dev Disord. 2022 Jun;52(6):2388-2399. doi: 10.1007/s10803-021-05128-z. Epub 2021 Jul 7.
citation: Burke MM, Cheung WC, Li C, DaWalt L, Segal J, Taylor JL. Parental Perceptions of Service Access for Transition-Aged Youth With Autism During COVID-19. Intellect Dev Disabil. 2022 Oct 1;60(5):369-381. doi: 10.1352/1934-9556-60.5.369.