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Adaptive Interventions for Autism

N/A

Waitlist Available

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For children over the age of 30 months, they must meet clinical cutoff on the ADOS-2, Module 1 or 2.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline(entry), phase1 midpoint (5 weeks post entry) and end(10 weeks post entry), phase2 midpoint (15 weeks post entry) and end(20 weeks post entry), and phase3 midpoint(25 weeks post entry) and end(30 weeks post entry), and 1 year follow-up post entry

Awards & highlights

Study Summary

This trial is testing an adaptive intervention approach to address the limited evidence for parent-mediated interventions for young children with ASD. The study will test the optimal sequence of intervention delivery and specific parent and child characteristics that may moderate treatment success in three 10-week stages of intervention.

Who is the study for?

This trial is for young children aged 12 to 36 months who are at risk of autism or diagnosed with it, and have a parent available twice weekly for sessions. Children under 30 months need elevated ADOS-T scores; those over must meet clinical cutoffs on the ADOS-2. Exclusions include seizures not stabilized by medication, physical disorders, or co-morbid syndromes unless specified.Check my eligibility

What is being tested?

The study tests an adaptive intervention approach in three stages: initial randomization to parent education or direct coaching, re-randomization to test optimal sequence and factors affecting success, and final phase exploring maintenance via remote contact or home visits. It aims to personalize interventions based on child-parent characteristics.See study design

What are the potential side effects?

As this trial involves educational and behavioral interventions rather than medications, traditional side effects are not expected. However, there may be indirect effects such as increased stress due to participation requirements or disappointment if desired outcomes aren't achieved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is over 30 months old and meets the criteria on the ADOS-2 test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline(entry), phase1 midpoint (5 weeks post entry) and end(10 weeks post entry), phase2 midpoint (15 weeks post entry) and end(20 weeks post entry), and phase3 midpoint(25 weeks post entry) and end(30 weeks post entry), and 1 year follow-up post entry

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline(entry), phase1 midpoint (5 weeks post entry) and end(10 weeks post entry), phase2 midpoint (15 weeks post entry) and end(20 weeks post entry), and phase3 midpoint(25 weeks post entry) and end(30 weeks post entry), and 1 year follow-up post entry

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline(entry), phase1 midpoint (5 weeks post entry) and end(10 weeks post entry), phase2 midpoint (15 weeks post entry) and end(20 weeks post entry), and phase3 midpoint(25 weeks post entry) and end(30 weeks post entry), and 1 year follow-up post entry for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Joint Engagement on the Caregiver-child interaction (CCX) over the course of the study

Secondary outcome measures

BOSCC

Caregiver Expectancies /Belief in the Intervention

Caregiver-child interaction (CCX)

+4 more

Other outcome measures

An electroencephalogram (EEG) test

Nonverbal Developmental Quotients (DQ) from Mullen

Polygenetic risk score (PRS)

+2 more

Trial Design

2Treatment groups

Active Control

Group I: CHILD focused interventionActive Control1 Intervention

In the CF condition both parent and child will attend the 90-minute session twice weekly. The session will be divided into 30-minute segments and include two 30-minute individualized 1-on-1 sessions with a trained interventionist.

Group II: PARENT focused interventionActive Control1 Intervention

The PF condition will consist of a 90-minute parent group session twice per week. The group will comprise 3 to 4 parents and will focus on psychoeducation and support/well-being for the parent.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,528 Previous Clinical Trials

10,276,731 Total Patients Enrolled

Media Library

CHILD focused intervention Clinical Trial Eligibility Overview. Trial Name: NCT03253081 — N/A

Autism Research Study Groups: CHILD focused intervention, PARENT focused intervention

Autism Clinical Trial 2023: CHILD focused intervention Highlights & Side Effects. Trial Name: NCT03253081 — N/A

CHILD focused intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03253081 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research program accommodate mature participants?

"For this medical trial, the ideal patient must be between 12 months and 36 months of age."

Answered by AI

Are additional participants needed for this experiment currently?

"As per the listings on clinicaltrials.gov, this medical study is not taking in any new patients at present as it was last updated on October 31st 2022. It had initially been posted back in June 15th 2018. However, there are other trials that have started enrolling candidates recently ."

Answered by AI

What kind of individuals are eligible to participate in this research?

"This clinical trial is recruiting 120 children with autistic disorder, aged between 1 year and 3 years old. The enrolment requirements include a score of elevated risk on the ADOS-2 test and professional medical concern from either a pediatrician or psychologist. Additionally, for participants younger than 30 months who may not have an ASD diagnosis yet, they are required to register in mild-to-moderate or moderate-to-severe risk categories on the ADOS-T assessment. For those above 30 months age threshold must meet cutoff scores set by the Module 1 or 2 of the ADOS-2 tests. Finally, it is essential that a parent be"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Heterogeneity in ASD: Biological Mechanisms, Trajectories, and Treatment Response

Connie Kasari, Ph.D. 2018. "Heterogeneity in ASD: Biological Mechanisms, Trajectories, and Treatment Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03253081.

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