Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06125093
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-10-23
Brief Title:
Study of an Early Parenting Intervention for Children With Genetic Abnormalities and Mental Health Problems
Sponsor:
Fundació Sant Joan de Déu
Organization:
Fundació Sant Joan de Déu
Study Overview
Official Title:
Early Treatment for Children With Mental Health Problems and Genetic Abnormalities Through a Parenting Intervention The GAP A Pragmatic Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-11
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:
The GAP
Brief Summary:
The GAP study is a randomized controlled trial that aims to determine the feasibility and efficacy of the Incredible Years Autism Spectrum and Language Delays IY-ASLD intervention for families of children with developmental problems from a genetic basis It is a multicentric trial where families will randomly be assigned to the intervention group or to a control group they will follow their usual treatment The intervention will be carried out in an online format and it will involve 22 weekly group sessions The results of The GAP study will help clinicians and policy makers in guiding towards evidence-based treatment options for these particularly vulnerable group of infants
Detailed Description:
Children born with genetic abnormalities have higher risk of presenting developmental and mental health problems Their parents tend to express higher anxiety levels as parenting children with developmental problems can be a stressful challenge for many families These infants can present important behaviour emotion regulation and social interaction problems These problems usually have a complex clinical presentation determined by their genetic abnormality Despite many of their impairing symptoms can overlap with the characteristics of the Autism Spectrum Disorder ASD in many cases they do not meet criteria for a full-blown ASD diagnosis These patients are placed in a double disadvantaged situation as on top of suffering a genetic disease they do not usually enter the ASD care-pathways and do not have access to effective therapies for their impairing symptoms This problem should be addressed as there is wide scientific evidence on early parenting programs that improve infants developmental problems and parents mental health These parenting programs are structured interventions that provide parenting skills to improve the acquisition of childrens social and emotion regulation abilities Such interventions have been widely implemented internationally but unfortunately most families treated within our mental health system still do not have access to them A good example is the parenting program Incredible Years Autism Spectrum and Language Delays IY-ASLD focused on improving young childrens development and parental stress levels Recently the feasibility and acceptability of implementing this program in different areas of the national territory has been studied with high satisfaction levels expressed by participant families parents of children with language delays or ASD However the scientific evidence is very limited for children with developmental problems from a genetic basis particularly for those with dysfunctional symptoms that do not meet diagnostic threshold for an ASD diagnosis
The GAP study aims to determine for the first time the feasibility and efficacy of the IY-ASLD intervention for families of children with developmental problems from a genetic basis It is a multicentric randomized controlled trial where families will randomly be assigned to the intervention group or to a control group they will follow their usual treatment As genetic abnormalities are rare clinicians will carry out the intervention in an online format 22 weekly sessions reaching out all affected families that live scattered throughout the national territory The results of The GAP study will help clinicians and policy makers in guiding towards evidence-based treatment options for these particularly vulnerable group of infants
The GAP study aims to determine for the first time the feasibility and efficacy of the IY-ASLD intervention for families of children with developmental problems from a genetic basis It is a multicentric randomized controlled trial where families will randomly be assigned to the intervention group or to a control group they will follow their usual treatment As genetic abnormalities are rare clinicians will carry out the intervention in an online format 22 weekly sessions reaching out all affected families that live scattered throughout the national territory The results of The GAP study will help clinicians and policy makers in guiding towards evidence-based treatment options for these particularly vulnerable group of infants
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 434U2022 | OTHER_GRANT | Fundació La MaratóTV3 | None |