Advocating for Supports to Improve Service Transitions

NCT04173663 | Completed Results

• 1 other identifier: 191187
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 3

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.

Conditions

Autism Spectrum Disorder; Autism

Outcome Measures

Primary Outcomes (7)

• 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 intervention-end, up to month 10

• 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 intervention-end, up to month 10

• 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 overall score is calculated by averaging all items and can range from 1 to 5, with higher scores indicating more skills/comfort in advocating for their offspring.

  Baseline to intervention-end, up to month 10

• 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, up to month 21

• 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 the total number of services that the family applied form (e.g., supplemental security income \[SSI\], vocational rehabilitation services, housing choice voucher). The number of services families can apply for ranges from 0 to 9.

  Baseline to 6-month post-intervention, up to month 15; Baseline to 12-month post-intervention, up to month 21

• 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. For this analysis, services are disaggregated into two types: government (e.g., supplemental security income \[SSI\], vocational rehabilitation services, housing choice voucher) and direct services (e.g, speech-language pathology, respite care, mental health services). The number of government services the family can receive ranges from 0 to 9. The number of direct services the family can receive ranges from 0 to 21.

  Baseline to 6-month post-intervention, up to month 15; Baseline to 12-month post-intervention, up to month 21

• 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. This measure is only applicable to youth who have exited high school.

  Baseline to 6-month post-intervention, up to month 15; Baseline to 12-month post-intervention, up to month 21

Secondary Outcomes (3)

• Social Participation Youth Outcomes

  Baseline to 12-month post-intervention, up to month 21

• Change in Access to Services Interview: Unmet Service Needs

  Baseline to 6-month post-intervention, up to month 15; Baseline to 12-month post-intervention, up to month 21

• Access to Services Interview: Barriers to Service Receipt

  Baseline to 12-month post-intervention, up to month 21

Study Arms (2)

ASSIST intervention group

EXPERIMENTAL

This group will attend the 12 sessions of the ASSIST training program (one 2-hour session per week for 12 weeks).

Behavioral: ASSIST

Control: Written materials only group

OTHER

This informational control group will receive the ASSIST binder and all written materials developed for the program on the same schedule as the treatment group but will not attend the group sessions. After the treatment group is treated and follow up data is collected for comparison between treatment and control, the control group will have the option to take the ASSIST training program.

Behavioral: ASSIST

Interventions

ASSIST BEHAVIORAL

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.

ASSIST intervention group; Control: Written materials only group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• parents are willing to be randomized to the treatment or control condition;
• 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;
• 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;
• 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
• the participating parent is proficient with the English language, as all ASSIST presentations and data collection materials are in English.

You may not qualify if:

• 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;
• parents NOT willing to be randomized to the treatment or control condition;
• parents and/or youth do NOT live in one of the states where the intervention is being delivered;
• The youth does not have a previous diagnosis of ASD from an educational or health care provider
• The youth does not meet lifetime cut-offs for ASD in a telephone screening of the Social Communication Questionnaire, answered by the parent.
• The participating parent is not proficient with the English language.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• University of Illinois at Urbana-Champaign: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (3)

University of Illinois at Urbana-Champaign

Chicago, Illinois, 60007, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Waisman Center at University of Madison-Wisconsin

Madison, Wisconsin, 53558, United States

Location

Related Publications (9)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27739234 BACKGROUND

• 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.

  PMID: 22466690 BACKGROUND

• 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.

  PMID: 28070786 BACKGROUND

• 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.

  PMID: 16367493 BACKGROUND

• 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.

  PMID: 34232419 RESULT

• 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.

  PMID: 36162047 RESULT

Related Links

• Transitions Lab Website

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Limitations and Caveats

We could not analyze whether treatment targets mediate the relationship between ASSIST participation and youth outcomes of employment/PSE, social participation, and service access (specific aim 3), as we did not detect a treatment effect. The results of the trial were likely impacted by the COVID-19 pandemic.

Results Point of Contact

• Title: Julie Lounds Taylor, PhD, principal investigator
• Organization: Vanderbilt University Medical Center

julie.l.taylor@vumc.org

615-343-5659

Study Officials

• Julie Lounds Taylor, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research personnel collecting follow-up data are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: November 22, 2019
• Study Start: January 3, 2020
• Primary Completion: March 1, 2022
• Study Completion: August 1, 2023
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)