Parental Education for Autism

(FITBI Trial)

Overseen By Brian Boyd, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas

Must not be taking: Psychotropics

Disqualifiers: Genetic disorder, Self-injury, ABA services, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new family-based treatment, called FITBI (Family-Implemented Treatment on the Behavioral Inflexibility of Children With Autism), can reduce negative behaviors and enhance positive outcomes for young children with autism spectrum disorder (ASD). Delivered remotely through video sessions, the treatment is accessible for families. Participants will receive either the FITBI treatment, which uses positive reinforcement, or parent education sessions on ASD-related topics. The trial seeks children aged 3 to 9 with a confirmed autism diagnosis who exhibit significant repetitive behaviors affecting daily life. As an unphased trial, it offers families the chance to access innovative treatment strategies that could improve their child's daily life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants should not have changed their psychotropic medications in the last 6 weeks. This might mean that stable medication use is required.

What prior data suggests that this family-based treatment is safe for children with autism?

Research has shown that the Family-Implemented Treatment for Behavioral Inflexibility (FITBI) is generally well-received. FITBI helps parents manage repetitive and inflexible behaviors in children with autism. Conducted entirely online through telehealth, all sessions are virtual. This method is considered low risk because it uses behavioral techniques instead of medications and does not involve any physical procedures.

Specific information on negative effects from the FITBI treatment itself is not available. However, its non-invasive nature suggests it is safe for participants. Behavioral treatments like FITBI typically carry fewer risks compared to medical treatments. For those considering participation, FITBI is designed to be a supportive and safe choice for families. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parental Education for Autism trial because it explores innovative ways to support families with children on the autism spectrum. Unlike traditional in-person therapy sessions, the FITBI treatment uses reinforcement-based learning delivered entirely via telehealth, offering flexibility and accessibility for parents. This remote approach could break down barriers to receiving care, making it easier for families to engage in consistent treatment sessions from the comfort of their own homes. By focusing on parental education and empowerment, this trial aims to enhance the family's ability to support their child, potentially leading to better outcomes for children with autism.

What evidence suggests that this trial's treatments could be effective for autism?

Research has shown that the Family-Implemented Treatment for Behavioral Inflexibility (FITBI), one of the treatments in this trial, reduces repetitive behaviors in children with autism. Studies have found that FITBI improves children's behavior by making them less rigid in their actions, with these improvements lasting for at least six months after treatment ends. Families using FITBI report feeling less stressed and observe that their children handle everyday tasks better. Overall, evidence suggests that FITBI effectively helps young children with autism manage difficult behaviors. Another treatment arm in this trial, Parent Education, provides information relevant to parenting a young child with ASD, which may also support families in managing autism-related challenges. ^{1 2 3 5 6}

Who Is on the Research Team?

Brian Boyd, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for children aged 3 to 9.5 years with autism who show significant repetitive behavior and have been previously diagnosed with ASD. They must score above a certain level on a specific behavior scale and meet ASD criteria on two diagnostic tools. Children can't join if they've had recent changes in psychotropic meds, receive extensive ABA therapy at home, have certain genetic disorders, or engage in intense self-harm.

Inclusion Criteria

I am between 3 and 9 years old.

Exhibiting clinically significant levels of repetitive behavior (Score >26 on Repetitive Behavior Scales-Revised)

ASD criteria on Social Communication Questionnaire-Lifetime and Autism Diagnostic Interview-Revised

Exclusion Criteria

My child gets more than 20 hours of ABA therapy at home weekly.

I have a genetic disorder that makes my symptoms worse.

Child engages in serious self-injurious behavior with intensity or frequency that warrants hospitalization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Remote delivery of FITBI intervention with 13 weekly sessions and 3 booster sessions over 6 months

6 months

16 remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 6 weeks, 12 weeks, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• FITBI
• Parental Education

Trial Overview

The study tests a new family-based treatment called FITBI for children with autism that targets repetitive behaviors using videoconferencing technology. The aim is to reduce the negative impact of these behaviors while improving positive outcomes.

How Is the Trial Designed?

Group I: FITBI Experimental Treatment 1 Intervention

Reinforcement-based learning procedures delivered via telehealth in 16 remote-delivered treatment sessions - 13 weekly and 3 booster treatment sessions over 6 month period.

Group II: Parent Education Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Kansas

Lead Sponsor

Trials

157

Recruited

332,000+

Published Research Related to This Trial

The FAUT-E parent training program significantly improved children's behavior, as evidenced by a medium effect size on the Aberrant Behavior Checklist after the intervention and at a follow-up three months later, indicating its efficacy in managing behaviors associated with autism spectrum disorder.

The training was easy to implement and did not increase parental stress, suggesting it is a safe and practical option for parents of children newly diagnosed with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Post Effects of the Psychoeducational, Autism-Specific Parent Training FAUT-E. Medda, JE., Kitzerow, J., Schlitt, S., et al.[2021]

In a four-week randomized trial involving parents of children with autism spectrum disorder, those who completed an interactive web training reported a significant reduction in their children's challenging behaviors and an increase in the use of effective behavioral interventions.

The positive effects of the web training were observed to persist for up to 12 weeks after the training, suggesting its potential utility, although high dropout rates and possible side effects indicate it should not be used as a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Interactive Web Training to Support Parents in Reducing Challenging Behaviors in Children with Autism. Turgeon, S., Lanovaz, MJ., Dufour, MM.[2021]

Parent training (PT) is an effective intervention for reducing disruptive behavior in children with autism spectrum disorder (ASD), showing a significant effect size of -0.59 based on a review of eight randomized controlled trials involving 653 participants.

The variability in PT's effectiveness across studies suggests that factors like sample size, treatment duration, and control conditions may influence outcomes, highlighting the need for further research to optimize PT implementation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-analysis of Parent Training for Disruptive Behavior in Children with Autism Spectrum Disorder. Postorino, V., Sharp, WG., McCracken, CE., et al.[2018]

The parenting training program was successfully implemented with 89% of families completing it, showing that it can be feasibly integrated into early intervention and early childhood special education settings for children with autism.

Post-intervention, parents reported improved use of treatment strategies, increased language use in children, and reduced parenting stress, indicating the program's effectiveness in enhancing communication skills and supporting families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a school-based parent training program for preschoolers with ASD. Ingersoll, BR., Wainer, AL.[2019]

Parent-Child Interaction Therapy (PCIT) significantly reduced disruptive behaviors in children with autism spectrum disorder (ASD) aged 4-10 years, as shown in a randomized clinical trial with 55 participants.

The study found that PCIT improved parent-child communication and compliance while reducing parental stress, and these benefits were consistent regardless of the severity of ASD, language skills, or age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-Child Interaction Therapy for Children with Disruptive Behaviors and Autism: A Randomized Clinical Trial. Allen, K., Harrington, J., Quetsch, LB., et al.[2023]

A pilot study involving 38 caregivers of children with autism spectrum disorder (ASD) evaluated a novel 6-session brief behavioral parent training (BPT) that effectively targeted high-frequency challenging behaviors.

Caregivers who participated in the BPT reported higher satisfaction and acceptability compared to those in the active control group, indicating that this intervention is both feasible and well-received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Evaluation of a Brief Behavioral Parent Training for Challenging Behavior in Autism Spectrum Disorder. Rohacek, A., Baxter, EL., Sullivan, WE., et al.[2023]

About 25% of young children with Autism Spectrum Disorder (ASD) in the study had disruptive behavior problems that could benefit from Behavioral Parent Training (BPT), but only one-third of these families were referred to such programs, highlighting a gap in access to necessary interventions.

Caregivers expressed a strong interest in BPT, especially in formats like telehealth and group sessions, indicating that tailoring delivery methods to parent and child characteristics could enhance engagement and satisfaction with the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training Engagement Among Young Children With Autism Spectrum Disorder. Ros-DeMarize, R., Klein, J., Carpenter, LA.[2023]

A study involving 1,089 ABA providers revealed that the number of professional training experiences significantly influences how extensively these providers use parent training strategies for children with autism spectrum disorder (ASD).

Only 15% of providers utilized manualized parent training programs, but those who did were more likely to implement parent training effectively, highlighting the importance of structured resources in enhancing treatment practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Professional Training Experiences and Manualized Programs in ABA Providers' Use of Parent Training With Children With Autism. Ingersoll, B., Straiton, D., Caquias, NR.[2020]

In a study involving 24 children with Autism Spectrum Disorder receiving intensive behavior interventions, those whose parents were actively involved in treatment showed significantly better outcomes in autism severity and developmental skills compared to a comparison group of 20 children receiving eclectic interventions.

The research found that higher parental stress negatively impacted treatment fidelity, suggesting that supporting parents in managing stress could enhance the effectiveness of interventions for their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent inclusion in Early Intensive Behavioral Intervention: the influence of parental stress, parent treatment fidelity and parent-mediated generalization of behavior targets on child outcomes. Strauss, K., Vicari, S., Valeri, G., et al.[2022]

Out of 1,231 studies evaluated, only 36 included a parent education component aimed at improving expressive verbal communication in nonverbal or minimally verbal children with autism spectrum disorder, highlighting a significant gap in research.

The review found considerable variability in the design and implementation of parent education programs, with unclear descriptions and few studies measuring how well parents implemented the interventions, suggesting a need for more standardized approaches in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent Education in Studies With Nonverbal and Minimally Verbal Participants With Autism Spectrum Disorder: A Systematic Review. Koegel, LK., Bryan, KM., Su, PL., et al.[2021]

A behavioral skill training package significantly improved the ability of three mothers to implement discrete trial teaching techniques with their children who have autism spectrum disorder.

The training not only enhanced the mothers' teaching skills but also led to positive changes in their children's behavior, demonstrating the effectiveness and lasting impact of the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Parents in Saudi Arabia to Implement Discrete Trial Teaching with their Children with Autism Spectrum Disorder. Eid, AM., Aljaser, SM., AlSaud, AN., et al.[2020]

In a study involving 21 parents of children with autism spectrum disorders, adherence to behavior management strategies was reported to be below mastery criteria in five out of six skill areas, indicating a gap between training and implementation.

Parents' perceptions, such as their confidence in the intervention's effectiveness and their acceptance of their child, were significantly correlated with adherence levels, suggesting that improving caregiver confidence could enhance the application of learned strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to treatment in a behavioral intervention curriculum for parents of children with autism spectrum disorder. Moore, TR., Symons, FJ.[2019]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05125003?tab=table

Family-Implemented Treatment on the Behavioral ...

The DORBA is an observational measure of restricted and repetitive behaviors in children with ASD based on clinician- or caregiver-child interactions.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/21161576/

Effects of a family-implemented treatment on the repetitive ...

We developed Family-Implemented Treatment for Behavioral Inflexibility (FITBI) to target the full variety of repetitive behaviors found in autism.

3.

trial.medpath.com

trial.medpath.com/clinical-trial/aec04240e37352f5/parent-implemented-treatment-asd

Family-Implemented Treatment on the Behavioral Inflexibility ...

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 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3709848/

Effects of a Family-Implemented Treatment on the ...

We developed Family-Implemented Treatment for Behavioral Inflexibility (FITBI) to target the full variety of repetitive behaviors found in autism. For the ...

5.

autismsciencefoundation.org

autismsciencefoundation.org/participate_research/parent-coaching-research-study-for-repetitive-or-inflexible-behaviors-the-fitbi-study/

Parent Coaching Research Study for Repetitive or ...

The FITBI Study partners caregivers of autistic children with trained therapists to provide coaching for inflexible or repetitive behaviors that are interfering ...

6.

fitbi.ku.edu

fitbi.ku.edu/

Family-Implemented Treatment for Behavioral Inflexibility ...

The Family-Implemented Treatment for Behavioral Inflexibility (FITBI) Project is a research study delivered via telehealth that provides caregiver coaching.