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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

Must not have

Are not co-morbid with other syndromes or diseases unless they come from Project I in our center- 22q11 deletion or TSC children at 12 months with concern for ASD on the ADOS-T.

Do not have seizures or are stable on anti-seizure medication

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

No Placebo-Only Group

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have 22q11 deletion or TSC and concerns for ASD, but no other major health issues.

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I do not have seizures or they are controlled with medication.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

BOSCC

Caregiver Expectancies /Belief in the Intervention

Caregiver-child interaction (CCX)

+4 more

Other study objectives

An electroencephalogram (EEG) test

Nonverbal Developmental Quotients (DQ) from Mullen

Polygenetic risk score (PRS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met