An interventional study of Early Social Interaction Project- PII and Early Social Interaction Project- IES in Autistic Disorder, sponsored by Florida State University. Completed at 2 sites in United States. Open to participants aged 16 Months to 20 Months. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by Florida State University · Not applicable, Interventional, and Treatment
This study will compare the effectiveness of two parent-based programs for helping young children at risk of autism.
Autism is a problem with normal social development and is characterized by impairments in three categories: social skills, language, and behavior. Symptoms include disinterest or inability to have normal social relationships, abnormal speech or usage of phrases, and repetitive movements or rituals; these symptoms generally emerge by 18 months of age. Autism is a spectrum disorder, meaning that its symptoms can range in severity from mild to severe. There is no cure for autism, nor is there a single known cause. There are only factors known to make it more likely for children to develop autism. These include being a male, having siblings with the disorder, having certain other disorders, or having an older father. Treatments for autism generally include therapies that help children develop social communication skills and that help structure family time and school so that parents and teachers can address particular difficulties children with autism might have. Medications may also be used to counteract anxieties or compulsive behaviors.
Research has shown that earlier interventions in children who are at risk of autism may lead to better outcomes. This study will compare two interventions for developing social communication skills in children who are at risk of autism and are between 16 and 20 months old. The parent-implemented intervention (PII) will be a more intense, individualized approach, teaching parents to embed 25 hours of social communication skills practice per week in their children's daily lives. The information, education, and support (IES) intervention will offer parents a support group and place to practice methods of helping their children learn adaptive social communication.
Participation in this study will last 18 months. Participants will be randomly assigned to first receive 9 months of either PII or IES and then receive 9 months of whichever intervention they did not receive initially. The PII intervention will involve three weekly sessions for 7 months, then two weekly sessions for 2 months. The IES intervention will involve group meetings twice monthly and offer a playground where parents can practice intervention strategies with their children. All parents will complete questionnaires about family resources and social and emotional issues before the first intervention begins, after 9 months when the intervention changes, and after 18 months when the second intervention ends. Children and parents will also be assessed once a month throughout the study on social communication, autism symptoms, developmental level, and hours spent on learned strategies or techniques outside the study visits. These assessments will involve clinical assessments of parent and child behaviors (some of which will be videotaped), tests of children's abilities, and reports by parents on strategies and techniques used outside the clinic.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 82 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.
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Exclusion Criteria:
This group will first receive the Early Social Interaction (ESI) model individual parent-implemented intervention (PII) for 9 months, followed by the ESI model group information, education, and support (IES) intervention for 9 months.
Behavioral: Early Social Interaction Project- PII · Behavioral: Early Social Interaction Project- IES
The group will first receive ESI group IES condition for 9 months, followed by ESI individual PII for 9 months.
Behavioral: Early Social Interaction Project- PII · Behavioral: Early Social Interaction Project- IES
The PII is an intensive, individualized treatment that teaches parents how to support social communication skills in children with autism by embedding skills practice within everyday routines, activities, and places. Participants will have three 75-minute sessions weekly with study administrators for the first 7 months of the study. Participants will then have two sessions per week for the final 2 months of the study. Children will also practice socialization embedded in normal activities for 25 hours a week outside of study visits.
The IES intervention provides access to a support group meeting twice monthly for children with autism and their parents. The support group provides information to families and a playgroup where parents may practice intervention strategies under the supervision of study officials knowledgeable about autism spectrum disorders.
Child measures of autism symptoms, social communication, developmental level, and adaptive behavior
Time frame: Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month
Parent report measures of family functioning, daily hassles, and treatment satisfaction
Time frame: Measured before treatment, at crossover, and after treatment
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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