N/A N=185 Randomized Single-blind Treatment

Advocating for Supports to Improve Service Transitions

Autism Spectrum Disorder · Autism

Bottom Line

View on ClinicalTrials.gov: NCT04173663 ↗

Enrolled (actual)

185

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Treatment Target: Change in Parental Empowerment Scale — 4.93; 0.61 score on a scale (change score) — p=.092

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ASSIST (Behavioral)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Target: Change in Parental Empowerment Scale	4.93; 0.61	.092
PRIMARY Treatment Target: Change in Parental Knowledge About Adult Services Questionnaire	2.16; 0.20	.0000154 sig
PRIMARY Treatment Target: Change in Advocacy Skills and Comfort Scale	0.35; 0.15	.014 sig
PRIMARY Change in Advocacy Activities Scale	-0.84; -1.34	0.883
PRIMARY Change in Access to Services Interview: Number of Services the Family Applied for	0.07; 0.10; 0.08; 0.10	.308
PRIMARY Change in Access to Services Interview: Number of Services the Family is Receiving	0.52; 0.43; 0.50; 0.41; -0.07; -0.33	.699
PRIMARY Post-Secondary Youth Outcomes	7; 4; 2; 5	.510
SECONDARY Social Participation Youth Outcomes	0.13; -0.72	.361
SECONDARY Change in Access to Services Interview: Unmet Service Needs	-0.28; -0.43; -0.35; -0.70	.810
SECONDARY Access to Services Interview: Barriers to Service Receipt	2.66; 2.71	.924

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.

Eligibility Criteria

Inclusion criteria include:

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.

Exclusion criteria include:

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04173663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.