An interventional study of FITBI and Parental Education in Autism Spectrum Disorder and Repetitive Compulsive Behavior, sponsored by University of Kansas. Recruiting at 1 site in United States. Open to participants aged 3 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by University of Kansas · Not applicable, Interventional, and Treatment
The overall goal of this project is to determine whether a new form of family-based treatment for repetitive and inflexible behaviors, delivered using videoconferencing technology, can counter any negative effects of those behaviors, but also improve positive outcomes for young children with ASD.
The overall goal of this project is to conduct a parallel group randomized controlled trial comparing remote delivery of FITBI (13-week intervention + 3 booster sessions over 6 months) to remote delivery of a parent education only (PE) control condition in a final sample size of 100 (3 years, 0 months to 9 years, 6 months) children with ASD and high rates of ritualistic repetitive behaviors. We will use TORSH, a comprehensive secure online platform that enhances therapist-parent coaching via telehealth. Further, an important objective of this proposal is to examine child and parent factors associated with treatment response and uptake in order to advance translational research and knowledge on personalized intervention approaches. Thus, the aims of this project are to:
Aim 1: Examine the acute and distal effects of the FITBI intervention on child and parent outcomes.
H1: In comparison to a PE only condition, FITBI will result in reductions in children's repetitive behaviors and increases in appropriate play skills immediately post-treatment.
H2: Effects of the FITBI intervention will be maintained at a 6-month follow-up and increases in child adaptive functioning and decreases in parent stress will be found.
Aim 2: Determine if the FITBI intervention shows differential treatment effects for lower versus higher order repetitive behaviors.
H1: FITBI will be effective at treating both lower and higher order RRBIs.
Aim 3: Examine if child variables (i.e., IQ and anxiety) moderate treatment response.
H1: Based on prior behavioral intervention research, it is hypothesized that children with higher IQs and fewer symptoms of anxiety at pretreatment, will show a better treatment response.
Aim 4: Explore if parent variables (i.e., SES, race/ethnicity, marital status, and stress) predict intervention fidelity and telehealth acceptance.
H1: As this is an exploratory aim, we do not have specific hypotheses.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 100 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →University of Kansas is the lead sponsor of 81 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reinforcement-based learning procedures delivered via telehealth in 16 remote-delivered treatment sessions - 13 weekly and 3 booster treatment sessions over 6 month period.
Behavioral: FITBI
Information relevant to parenting a young child with ASD (e.g. parent advocacy, developmental changes in ASD, treatment options) delivered via telehealth in 15 remote-delivered treatment sessions -12 weekly and 3 booster treatment sessions over 6 month period.
Behavioral: Parental Education
parents learn to identify high probability cues in the environment that can elicit RRBI symptoms and teach their child to inhibit repetitive behaviors and instead replace them with alternative and flexible play behaviors; and (b) teach parents how to embed this FITBI approach into their child's everyday routines
Sessions will cover relevant information on young children with ASD, including understanding the ASD diagnosis, developmental changes in ASD, educational planning, advocacy, and treatment options.
Behavioral Inflexibility Scale - Clinical Interview
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Time frame: Baseline
Behavioral Inflexibility Scale - Clinical Interview
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Time frame: 6 weeks
Behavioral Inflexibility Scale - Clinical Interview
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Time frame: 12 weeks
Behavioral Inflexibility Scale - Clinical Interview
video interview yields a severity score from 0 no impairment to 28 maximum impairment
Time frame: 6 months
Aberrant Behavior Checklist-Community (ABC-C)
online survey
Time frame: Baseline, 6 weeks, 12 weeks, and 6 month follow-up
Direct Observation of Repetitive Behaviors in Autism (DORBA)
The DORBA is an observational measure of restricted and repetitive behaviors in children with ASD based on clinician- or caregiver-child interactions.
Time frame: Baseline, 12 weeks, and 6 month follow-up
Behavioral Inflexibility Scale (BIS)
parent survey of severity with total score ranging from 0 (no problem) to 190 very severe on all 38 items
Time frame: Baseline, 6 weeks, 12 weeks, and 6 month follow-up
Plan to share: Yes — Participant data will be shared with the NDAR repository using their system of GUIDs.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available following the completion of the trial and data cleaning. It will remain in the archive as soon as the archive is supported.
Access criteria: Access criteria will be managed by the NDAR site.
No publications or documents are linked to this record.
Started Apr 2022 (actual). Primary completion is estimated for Dec 2025, 44 months after the start.
Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 44 months is above that.
Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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University of Kansas