Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05926687
Status:
RECRUITING
Last Update Posted:
2023-07-20
First Post:
2023-06-07
Brief Title:
Optimizing Outcomes for Young Autistic Children
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Optimizing Outcomes Through Sequencing Parent-Mediated Interventions for Young Children With Autism
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overarching goal of the proposed study is to a determine how best to sequence two parent-mediated interventions a social communication intervention Project ImPACT Improving Parents as Communication Teachers and a disruptive behavior intervention Parent Training for Disruptive Behavior and b examine moderators and mediators of intervention outcomes
Detailed Description:
Despite advances in early identification of and intervention for children with autism spectrum disorders ASD the long-term outcomes for children with ASD remain variable As many as 40 of children with ASD are minimally verbal at 9 years of age and 75 of adults with ASD have persistent social communication SC difficulties Furthermore as many as 70 of children with ASD have a co-occurring diagnosis of disruptive behavior DB disorder Parents play an important role in SC development and in the prevention of and intervention for DB As such the overarching goal of the proposed study is to a determine how best to sequence two parent-mediated interventions an SC intervention Project ImPACT Improving Parents as Communication Teachers and a DB intervention Parent Training for Disruptive Behavior and b examine moderators and mediators of intervention outcomes While evidence of efficacy and feasibility exist for both of these interventions individually an adaptive intervention approach that considers and optimizes both interventions has not been evaluated This type of adaptive intervention approach may be particularly needed in parent-mediated interventions due to the cost burden and complexity of teaching parents to use multiple intervention strategies To determine the optimal intervention sequence that considers parent moderators and parent use of intervention strategies the investigators propose a sequential multiple assignment randomized trial SMART design in which the investigators will initially randomly assign 184 children with ASD between 18 and 48 months of age to receive either the SC or DB intervention Following each respective manualized 12-week intervention first-stage intervention SC or DB the interventionist will measure the parents use of intervention strategies At this point all parents will be re-randomized before starting the second-stage intervention Second-stage intervention decisions are designed to be responsive to parents implementation of the first-stage intervention strategies That is parents who are implementing the first-stage intervention strategies with high fidelity high implementers will be re-randomized to receive the same intervention at a lower frequency Reduce or to receive the other intervention Switch Parents who are implementing the first-stage intervention strategies with low fidelity low implementers will be re-randomized to receive the same intervention with an additional parent instructional method such as video feedback Augment or to receive the other intervention Switch After 24 weeks of intervention 12 weeks for first stage 12 weeks for second stage the investigators will assess child SC skills child DB and family life participation in everyday activities The investigators will also measure parent-child joint engagement continually during intervention to examine the extent to which joint engagement mediates intervention outcomes The proposed research is significant because if an intervention for one domain SC or DB has an impact on the other an intervention sequence that systematically includes both interventions may have an even greater impact on both domains
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None