Telehealth Intervention for Disruptive Behavior in Autism

(THRIVE-ASD Trial)

Overseen By Rosmary Ros-Demarize, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Unstable psychotropics

Disqualifiers: Severe self-injury, others

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

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a therapy called Parent-Child Interaction Therapy (PCIT) delivered through telehealth for young children with autism and disruptive behavior. The goal is to determine if ten sessions of this online therapy, known as Tele-PCIT, can improve behavior compared to regular treatment. Families will be randomly assigned to either the telehealth therapy or their usual treatment and will undergo assessments before and after the treatment, with a follow-up in three months. Children with autism who struggle with disruptive behavior and come from low-income backgrounds may be suitable for this trial. As an unphased trial, this study offers families the opportunity to explore a potentially beneficial therapy option that could enhance their child's behavior.

Will I have to stop taking my current medications?

If your child is taking psychotropic medications (medications that affect mood, perception, or behavior) and their medication routine has been stable for at least one month, they can continue taking them during the trial. If the medication routine is not stable, they may need to adjust it before participating.

What prior data suggests that Tele-PCIT is safe for children with autism?

Research has shown that Tele-PCIT, a type of Parent-Child Interaction Therapy conducted through telehealth, is generally well-received by families. Studies have found that this therapy not only helps manage disruptive behavior in young children with autism but is also accepted by parents. For example, one study found that parents felt more confident and less stressed when using telehealth methods with their autistic children. Additionally, previous research suggests that Tele-PCIT effectively reduces disruptive behaviors when used alongside other treatments.

While specific data on negative side effects is lacking, the therapy's acceptance by parents and its effectiveness suggest it is safe to use. The trial is labeled "Not Applicable" for phase, indicating the treatment is considered non-invasive and low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tele-PCIT treatment because it offers a unique telehealth approach to managing disruptive behavior in children with autism, which can be more accessible and flexible for families compared to traditional in-person therapy. Tele-PCIT allows parents to engage in Parent-Child Interaction Therapy remotely, which can reduce barriers such as travel time and scheduling conflicts. This approach could potentially make effective behavioral interventions available to a wider audience, increasing the overall impact and reach of therapy for children with autism.

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

Research has shown that Tele-PCIT, or Parent-Child Interaction Therapy conducted online, can reduce disruptive behavior in young children with autism. In this trial, some participants will receive Tele-PCIT. One study found that parents noticed improvements in their children's behavior and experienced less stress. Another study demonstrated that Tele-PCIT helped these children develop better everyday skills. Early results also suggest that conducting PCIT over the internet effectively manages behavior problems in children aged 3 and up. Overall, these studies highlight the potential of Tele-PCIT as a promising treatment for disruptive behavior in children with autism. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for young children aged 2 to almost 7 with Autism Spectrum Disorder (ASD) who show disruptive behaviors. They must have a confirmed ASD diagnosis, understand language at a two-year-old level, come from low-income families on Medicaid, and not be on unstable psychotropic medications or exhibit severe self-injury.

Inclusion Criteria

Are of low SES background defined by having primary Medicaid

Have elevated levels of disruptive behavior problems as defined by the Eyberg Child Behavior Inventory

My child is between 2 and 6 years old.

Exclusion Criteria

My child is on psychotropic medication but hasn't been stable on it for a month.

I engage in severe self-harm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 sessions of Tele-PCIT or Treatment as Usual

12 weeks

10 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Post-treatment assessment

Assessment of child compliance, behavior problems, and parenting practices

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tele-PCIT
• Treatment as Usual

Trial Overview The study tests a short version of Parent Child Interaction Therapy (PCIT) done through telehealth against the usual treatment methods for managing disruptive behaviors in kids with ASD. Participants will be randomly placed into one of these two groups and assessed before, after treatment, and three months later.

How Is the Trial Designed?

Group I: Tele-PCIT (Parent-Child Interaction Therapy) Experimental Treatment 1 Intervention

Group II: Treatment as Usual Active Control 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Health Resources and Services Administration (HRSA)

Collaborator

Trials

88

Recruited

152,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37171780/

Tele-PCIT: Initial Examination of Internet Delivered PCIT for ... Results of the current study support the initial efficacy of Tele-PCIT for treating disruptive behavior in young children with ASD.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0213616325000308

Telehealth group parent training for children with autism ... Program effectiveness was evaluated using parent-reported measures on their children and on themselves assessing behavior problems, parental stress, and quality ...

3. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1408847/full

Investigation of the effectiveness of parent-child interaction ... This study aims to assess the initial result effectiveness of standard PCIT on the adaptive skills and school refusal behaviors of children exhibiting ...

4. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2800318

Telehealth Treatment of Behavior Problems in Young ... This randomized clinical trial investigates the effects of an internet-delivered parent-child interaction therapy for children aged 3 years ...

5. link.springer.com link.springer.com/article/10.1007/s10803-022-05482-6

A Parent-Mediated Telehealth Program for Children with ... This study investigates the effectiveness of a 6-month parent-mediated early intervention telehealth program for children with an autism spectrum disorder.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02721381

Comparative Efficacy of Self-directed & Therapist-assisted ... These preliminary findings suggest telehealth parent training interventions are highly acceptable to parents of children with ASD, and can result in ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1750946723001095

Meta-analysis of effectiveness of parent-mediated ... Telehealth interventions improved the implementation fidelity and self-efficacy and reduced the stress of parents of autistic children.

8. withpower.com withpower.com/trial/telehealth-intervention-for-disruptive-behavior-in-autism-eb76c

Telehealth Intervention for Disruptive Behavior in Autism ... The purpose of this research study is to evaluate a time-limited version of Parent Child Interaction Therapy (PCIT) delivered via telehealth for young ...

9. researchrepository.wvu.edu researchrepository.wvu.edu/cgi/viewcontent.cgi?article=13027&context=etd

A Randomized Controlled Trial of Group Telehealth ... Parent-Child Interaction Therapy (PCIT) has demonstrated effectiveness as a supplemental treatment for disruptive behaviors in children on the autism spectrum.