Advocating for Supports to Improve Service Transitions

Autism Spectrum Disorder Clinical Trial

— ASSIST  

Official title:

Project ASSIST: Advocating for Supports to Improve Service Transitions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04173663
• Other study ID #: 191187
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 3, 2020
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• ASSIST
The ASSIST program is a 12-week advocacy training to educate parents of youth with autism about the adult service system (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). It is a group training, comprised of didactic instruction, family-sharing activities, case studies, and group discussions. The ASSIST program for the proposed study will be directed at each site by an experienced Program Facilitator from the community with knowledge about group processes, person-centered planning, and adult service systems, who will be coached by a member of the study team. The ASSIST program will be delivered in full partnership with the local disability community. In most sessions, the Program Facilitator will be aided by community content experts who present the specifics of each topic.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Chicago	Illinois
United States	Waisman Center at University of Madison-Wisconsin	Madison	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	University of Illinois at Urbana-Champaign, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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.

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. — View 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.

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. — View 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.

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. — View 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. 20 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Advocacy Activities Scale	Examine whether ASSIST participation increases the intervention target of parent advocacy activities, measured using the Advocacy Activities measure. The 16-item instrument measures how frequently parents spend time in advocacy activities for the son/daughter with ASD. The response options range from 1 = not at all to 4 = very often. The total score can range from 16 to 64, with higher scores indicating greater parent participation in advocacy activities.	Baseline to 30-month post-intervention
Other	Change in Access to Services interview: Number of services the family applied for	Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2), the investigators will collect data (via a semi-structured interview) on total number of services that the family applied for.	Baseline to 24-month, and Baseline to 30-month post intervention
Other	Change in Access to Services interview: Number of services the family is receiving	Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2), the investigators will collect data (via a semi-structured interview) on total number of services that the family is receiving.	Baseline to 24-month, and Baseline to 30-month post intervention
Other	Change in Post-Secondary Vocational and Educational Participation	Test whether parent participation in the ASSIST intervention leads to increase in post-secondary vocational and educational participation for youth with ASD. The Vocational Index will be used to gather information on employment and post-secondary educational programs that youth with ASD are attending / attended 6 months after the intervention. The Vocational Index will be administered via structured interview.	Baseline to 24-month, and Baseline to 30-month post intervention
Primary	Treatment Target: Change in Parental Empowerment Scale	Examine whether ASSIST participation increases the intervention target of parental empowerment measured using the Family Empowerment Scale (FES). The 34-item questionnaire measures the extent to which parents feel empowered across three dimensions: family, the service system; and the larger community and political environment. Items are rated on a 5-point Likert Scale from 1= not at all true to 5 = very true. The total score can range from 34 to 170, with higher scores indicating greater empowerment.	Baseline to 3-month post-intervention
Primary	Treatment Target: Change in Parental Knowledge about adult services questionnaire	Examine whether ASSIST participation increases the intervention target of parental knowledge about adult service systems. A questionnaire based on a measure developed for the Volunteer Advocacy Program Transition (VAP-T) will be used to evaluate parental knowledge about adult services. The questionnaire consists of 22 multiple-choice questions asking for factual information about adult disability services and the adult disability service system. The total score can range from 0 to 22. Higher scores indicate greater knowledge of the adult disability service system.	Baseline to 3-month post-intervention
Primary	Treatment Target: Change in Advocacy Skills and Comfort Scale	Examine whether ASSIST participation increases the intervention target of parent advocacy skills measured by the Advocacy Skills and Comfort Scale (ASC). The 10-item measure assesses the degree to which parents feel comfortable and skilled in advocating for their offspring with ASD. Response options range from 1 = not at all to 5 = excellent. The total score can range from 10 to 50, with higher scores indicating more skills/comfort in advocating for their offspring.	Baseline to 3-month post-intervention
Primary	Change in Advocacy Activities Scale	Examine whether ASSIST participation increases the intervention target of parent advocacy activities. The 16-item instrument measures how frequently parents spend time in advocacy activities for the son/daughter with ASD. The response options range from 1 = not at all to 4 = very often. The total score can range from 16 to 64, with higher scores indicating greater parent participation in advocacy activities.	Baseline to 12-month post-intervention
Primary	Change in Access to Services Interview: Number of services the family applied for	Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2), the investigators will collect data (via a semi-structured interview) on total number of services that the family applied for.	Baseline to 6-month, Baseline to 12-month post intervention
Primary	Change in Access to Services Interview: Number of services the family is receiving	Test whether parent participation in the ASSIST intervention leads to increase access to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2) the investigators will collect data (via a semi-structured interview) on total number of services that the family is receiving.	Baseline to 6-month, Baseline to 12-month post intervention
Primary	Post-Secondary Youth Outcomes	Test whether parent participation in the ASSIST intervention leads to increase in post-secondary vocational and educational participation for youth with ASD. The Vocational Index will be used to gather information on employment and post-secondary educational programs that youth with ASD are attending / attended 6 months after the intervention. The Vocational Index will be administered via structured interview.	Baseline to 6-month, Baseline to 12-month post intervention
Secondary	Social Participation Youth Outcomes	Test whether parent participation in the ASSIST intervention leads to increase in social participation for youth with ASD. Questions developed to measure social participation will be used to measure the social participation achievements of the youth participants before and after ASSIST per parent-report. This measure consists of 10 items with a 5-point Likert scale ranging from 0 = Less than yearly or never to 4 = Several times a week. The total score can range from 0 to 40, with higher scores indicating greater social participation for the youth with ASD.	Baseline to 12-month post-intervention and Baseline to 30-month post-intervention
Secondary	Goal Attainment	Goal Attainment Scaling (GAS) will be used to measure the extent to which individualized goals identified in the person-centered planning session have been obtained. Goals are selected from a goal bank that includes 5 categories: Employment & Post-Secondary Education, Daily living, Social and Spirituality, Healthy Living, and Safety & Security. These goals are customized by parent and youth. The investigators will collect information on the youth's goals' progress status.	Baseline to 12-month post-intervention
Secondary	Satisfaction with Life Scale	The Satisfaction with Life Scale (SLS) is a short 5-item measure of an individual's subjective quality of life. The questionnaire asks parents to think about their youth and rate their agreement with the 5 statements on a 7-point scale, from 1 (Strongly Disagree) to 7 (Strongly Agree). The SLS scale allows participants to integrate and weigh these domains in whatever way they choose.	Baseline to 12-month post-intervention and Baseline to 30-month post-intervention
Secondary	Change in Access to Services Interview: Unmet service needs	Test whether parent participation in the ASSIST intervention leads to decrease in unmet service needs for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2), the investigators will collect data (via a semi-structured interview) on total number of unmet service needs that the family is experiencing / experienced.	Baseline to 6-month, Baseline to 12-month, Baseline to 24-month, and Baseline to 30-month post intervention
Secondary	Change in Access to Services Interview: Barriers to service receipt	Test whether parent participation in the ASSIST intervention leads to decrease in barriers to services for youth with ASD transitioning from high school to adulthood. Using questions developed for the National Longitudinal Transition Study-2 (NLTS-2), the investigators will collect data (via a semi-structured interview) on total number of barriers to services that the family is experiencing / experienced.	Baseline to 6-month, Baseline to 12-month, Baseline to 24-month, and Baseline to 30-month post intervention
Secondary	Other Characteristics of Employment/Post-Secondary Educational Position: Length of Time/Stability	The Vocational Index will be used to gather information on employment and post-secondary educational (PSE) programs that youth with ASD are attending/attended before and after the ASSIST intervention. The Vocational Index will be administered via structured interview.; Length of Time/Stability: Test whether parent participation in ASSIST leads to increase in employment and PSE stability for youth. The investigators will collect total number of youth activities.	Baseline to 6-month, Baseline to 12-month, Baseline to 24-month, and Baseline to 30-month post intervention
Secondary	Other Characteristics of Employment/Post-Secondary Educational Position: Hours Spent in Activity	The Vocational Index will be used to gather information on employment and post-secondary educational (PSE) programs that youth with ASD are attending/attended before and after the ASSIST intervention. The Vocational Index will be administered via structured interview.; Hours Spent: Test whether parent participation in ASSIST leads to increase in employment and PSE participation for youth. The investigators will collect total number of hours per week spent in these activities.	Baseline to 6-month, Baseline to 12-month, Baseline to 24-month, and Baseline to 30-month post intervention
Secondary	Other Characteristics of Employment/Post-Secondary Educational Position: Fit	The Vocational Index will be used to gather information on employment and post-secondary educational (PSE) programs that youth with ASD are attending/attended before and after the ASSIST intervention. The Vocational Index will be administered via structured interview.; Fit: Test whether parent participation in ASSIST leads to increase in youth satisfaction and degree of fit for their interest and skills in employment and PSE participation for youth. The investigators will collect information on if the job/position/program is a good fit for youth.	Baseline to 6-month, Baseline to 12-month, Baseline to 24-month, and Baseline to 30-month post intervention
Secondary	Change in Parental Empowerment Scale	Examine whether ASSIST participation increases the intervention target of parental empowerment measured using the Family Empowerment Scale (FES). The 34-item questionnaire measures the extent to which parents feel empowered across three dimensions: family, the service system; and the larger community and political environment. Items are rated on a 5-point Likert Scale from 1= not at all true to 5 = very true. The total score can range from 34 to 170, with higher scores indicating greater empowerment.	Baseline to 12-month, Baseline to 18-month, Baseline to 30-month post intervention
Secondary	Change in Parental Knowledge about adult services questionnaire	Examine whether ASSIST participation increases the intervention target of parental knowledge about adult service systems. A questionnaire based on a measure developed for the Volunteer Advocacy Program Transition (VAP-T) will be used to evaluate parental knowledge about adult services. The questionnaire consists of 22 multiple-choice questions asking for factual information about adult disability services and the adult disability service system. The total score can range from 0 to 22. Higher scores indicate greater knowledge of the adult disability service system.	Baseline to 12-month, Baseline to 18-month post-intervention
Secondary	Change in Advocacy Skills and Comfort Scale	Examine whether ASSIST participation increases the intervention target of parent advocacy skills measured by the Advocacy Skills and Comfort Scale (ASC). The 10-item measure assesses the degree to which parents feel comfortable and skilled in advocating for their offspring with ASD. Response options range from 1 = not at all to 5 = excellent. The total score can range from 10 to 50, with higher scores indicating more skills/comfort in advocating for their offspring.	Baseline to 12-month, and Baseline to 18-month post-intervention

External Links

•   Transitions Lab Website