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Behavioral Intervention

Peer Interventions for Autism (PIPA Trial)

N/A

Recruiting

Research Sponsored by University of Kansas

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up secondary at baseline, 5 weeks, 12 weeks, and 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate interventions to improve communication in preschoolers with ASD who have limited or no spoken language. Kids with ASD can benefit from peer-mediated interventions, but 30% remain minimally-verbal. This study will test different approaches to help improve communication.

Who is the study for?

This trial is for preschoolers aged 3 to 6 with Autism Spectrum Disorder who have limited or no spoken language. They should be using or ready to use a speech-generating device and primarily speak English at home. Children must not have major medical conditions besides ASD, lack symbol discrimination skills, or have impairments that prevent play with peers.

What is being tested?

The study tests peer-mediated interventions (PMIs) like Stay-Play-Talk in various forms to improve social communication in children with autism. It uses a SMART design where kids start with basic PMI and may advance based on their response, potentially adding devices for communication or more direct teaching strategies.

What are the potential side effects?

Since the interventions are behavioral treatments involving peer interaction and communication devices rather than medications, traditional side effects are not expected. However, there might be variations in individual responses to the intervention's social and communicative demands.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ secondary at baseline, 5 weeks, 12 weeks, and 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~secondary at baseline, 5 weeks, 12 weeks, and 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and secondary at baseline, 5 weeks, 12 weeks, and 16 weeks 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 rate of peer-directed communication acts

Secondary study objectives

Aberrant Behavior Checklist

Change in expressive language

Change in expressive language multi-words

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Stay_Play_Talk Plus Followed by Stay_Play_Talk Plus (SPT Plus Responders)Experimental Treatment1 Intervention

After being randomly assigned to the SPT Plus condition, these participants responded and therefore remained in this condition

Group II: Stay_Play_Talk Plus Followed by Randomization to Stay_Play_Talk Plus (SPT Plus - SPT Plus)Experimental Treatment1 Intervention

After being randomly assigned to the SPT Plus condition, these participants did not respond and were randomized to Stay_Play_Talk Plus in the second stage.

Group III: Stay_Play_Talk Plus Followed by Randomization to Stay_Play_Talk Advanced (SPT Plus - SPT Advanced)Experimental Treatment2 Interventions

After being randomly assigned to the SPT Plus condition, these participants did not respond and were randomized to Stay_Play_Talk Advanced condition in the second stage which incorporates direct instruction.

Group IV: Stay_Play_Talk Basic Followed by Randomization to Stay_Play_Talk Plus (SPT Basic - SPT Plus)Experimental Treatment2 Interventions

After being randomly assigned to the SPT Basic condition, these participants did not respond and were randomized to Stay_Play_Talk Plus in the second stage.

Group V: Stay-Play_Talk Basic Followed by Stay_Play_Talk Basic - (SPT Basic Responders)Active Control1 Intervention

After being randomly assigned to the SPT Basic condition, these participants responded and therefore remained in this condition

Group VI: Stay_Play_Talk Basic Followed by Randomization to Stay_Play_Talk Basic (SPT Basic - SPT BASIC)Active Control1 Intervention

After being randomly assigned to the SPT Basic condition, these participants did not respond but were randomized to stay in this condition to examine longer duration in this treatment.

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