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New treatment option for Autism
Official title Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention
ClinicalTrials.gov ID: NCT07471594
What this study is testing
- What it's testing
- Early Intervention (EI) systems are ill-equipped to serve the many children 12 to 36 months with early signs or a diagnosis of autism spectrum disorder (ASD). EI funded by Part C of the Individuals with Disabilities Education Act (IDEA) uses home-based service delivery, emphasizes family-centered care, and prioritizes family-defined concerns (i.e., patient-centered outcomes).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 36. Healthy volunteers may be eligible.
You may be able to join if
- The following is a list of inclusion and
You likely can't join if
- by participant group across all three research aims. Inclusion Criteria for All Participants:
- Able to provide written and informed consent;
- Both sexes and all racial and ethnic origins;
- English fluency (necessary for informed consent and measure completion) Inclusion Criteria for Providers:
- Is between 18 and 75 years of age
- Holds a contract with or formally employed by BabyNet
See the full eligibility criteria
- The following is a list of inclusion and
- by participant group across all three research aims. Inclusion Criteria for All Participants:
- Able to provide written and informed consent;
- Both sexes and all racial and ethnic origins;
- English fluency (necessary for informed consent and measure completion) Inclusion Criteria for Providers:
- Is between 18 and 75 years of age
- Holds a contract with or formally employed by BabyNet
- Provides services within BabyNet at least one half-hour per week
- Provides therapeutic services within BabyNet to at least one child 12-36 months who is 1) at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the...
- Not contracted or employed by BabyNet
- Provides services less than one half-hour per week
- Does not provide services to a child 12-36 months of age at high-likelihood for ASD and with elevated emotion dysregulation (based on the POSI and the EDI-YC) Inclusion Criteria for Caregiver in Caregiver-Child Dyad:
- Is between 18 and 75 years of age
- Is the legal guardian of the participating child
- Child is receiving services within BabyNet at least one half-hour per week - Caregiver participates or is present for BabyNet services Exclusion Criteria for Caregiver in Caregiver-Child Dyad:
- Not between 18 and 75 years of age
- Not the legal guardian of the child
- Not able to be present for BabyNet services Inclusion Criteria for Children in Caregiver-Child Dyad:
- Is between 12 and 36 months of age
- Is enrolled in BabyNet services at least one half-hour per week
- Is considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI
- Has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index. Exclusion Criteria for Children in Caregiver-Child Dyad:
- Is not between 12 and 36 months of age
- Is not receiving services in BabyNet at least one half-hour per week
- Is not considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI
- Does not have elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.
The study team makes the final eligibility decision.
Where it's taking place
- Columbia, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 months to 36 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbia, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.