Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596226
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Evaluating Pathways Mutual Gaze Protocol on Social Skills in Young Children Suspected of Autism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating The Efficacy of Pathways Parent-Mediated Interventions Mutual Gaze Protocol on Social Skills in Young Children Suspected of Having Autism A Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose of the Study The goal of this clinical trial is to find out if a technique called the mutual gaze procedure used in Pathways Early Intervention Pathways is the key to helping improve social communication language and everyday skills in young children 16-30 months old who are at high risk for autism particularly those from diverse cultural and language backgrounds
What Will Happen Researchers will compare two versions of the Pathways Intervention
Version 1 Includes mutual gaze strategies
Version 2 Does not include mutual gaze strategies
What to Expect Participants will
Attend 12 sessions of Pathways Intervention each lasting 15 hours or 15 weeks if there are cancellations
Come to the clinic for a developmental check-up three times before starting Pathways right after completing Pathways and three months after finishing Pathways
What Will Happen Researchers will compare two versions of the Pathways Intervention
Version 1 Includes mutual gaze strategies
Version 2 Does not include mutual gaze strategies
What to Expect Participants will
Attend 12 sessions of Pathways Intervention each lasting 15 hours or 15 weeks if there are cancellations
Come to the clinic for a developmental check-up three times before starting Pathways right after completing Pathways and three months after finishing Pathways
Detailed Description:
Purpose of the Study The primary goal of this clinical trial is to evaluate whether a parent-mediated treatment can improve social communication language and adaptive functioning in 16-30-month-old children from diverse cultural and language backgrounds who are at high risk for autism referred to as children with social challenges
Study Design
Study Phase NA
Intervention Model Participants are assigned to one of two groups in parallel
Study Description
Participants 80 children aged 16-30 months who show social communication challenges and are at high risk for autism will be randomly assigned to one of two groups
1 Group 1 Pathways Intervention with mutual gaze strategies
2 Group 2 Pathways Intervention without mutual gaze strategies
Intervention Sessions Participants will attend 12 sessions each lasting 15 hours over approximately 15 weeks allowing for possible cancellations of parent-mediated intervention in their homes or another convenient location
Assessments To track progress and evaluate long-term effects participants will undergo several culturally and linguistically appropriate assessments at three time points
1 Baseline Within two weeks before starting the intervention
2 Post-Intervention Within two weeks after completing the intervention
3 Three-Month Follow-Up 12-15 weeks after completing the intervention
Each evaluation will take around two hours and will include
Child Assessments
Mullen Scale of Early Learning MSEL Assesses general developmental age administered only at baseline
Communication and Symbolic Behavior Scales-Developmental Profile CSBS-DP Evaluates social communication
EarliPointTM Measures social verbal and nonverbal cognition
Caregiver Questionnaires
Vineland Adaptive Behavior Scales Third Edition VABS-III Assesses adaptive functioning
PhenX Toolkit Core Measures Collects family and child demographic information including parents and grandparents place of birth administered only at baseline
The CSBS-DP and VABS-III have been validated as appropriate measures for determining meaningful changes in children with or at high risk for autism based on previous research
Study Design
Study Phase NA
Intervention Model Participants are assigned to one of two groups in parallel
Study Description
Participants 80 children aged 16-30 months who show social communication challenges and are at high risk for autism will be randomly assigned to one of two groups
1 Group 1 Pathways Intervention with mutual gaze strategies
2 Group 2 Pathways Intervention without mutual gaze strategies
Intervention Sessions Participants will attend 12 sessions each lasting 15 hours over approximately 15 weeks allowing for possible cancellations of parent-mediated intervention in their homes or another convenient location
Assessments To track progress and evaluate long-term effects participants will undergo several culturally and linguistically appropriate assessments at three time points
1 Baseline Within two weeks before starting the intervention
2 Post-Intervention Within two weeks after completing the intervention
3 Three-Month Follow-Up 12-15 weeks after completing the intervention
Each evaluation will take around two hours and will include
Child Assessments
Mullen Scale of Early Learning MSEL Assesses general developmental age administered only at baseline
Communication and Symbolic Behavior Scales-Developmental Profile CSBS-DP Evaluates social communication
EarliPointTM Measures social verbal and nonverbal cognition
Caregiver Questionnaires
Vineland Adaptive Behavior Scales Third Edition VABS-III Assesses adaptive functioning
PhenX Toolkit Core Measures Collects family and child demographic information including parents and grandparents place of birth administered only at baseline
The CSBS-DP and VABS-III have been validated as appropriate measures for determining meaningful changes in children with or at high risk for autism based on previous research
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None