Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619821
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Effects of Parent-Adolescent Joint Interventions for Adolescents with Adverse Childhood Experiences
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Parent-Adolescent Joint Interventions for Adolescents with Adverse Childhood Experiences a Multi-Center Cluster Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
EASY-PEP
Brief Summary:
The study aims to examine the effectiveness of improving the mental health outcomes of participants specifically by reducing symptoms of depression anxiety and PTSD as measured by the Patient Health Questionnaire PHQ-9 the Generalized Anxiety Disorder-7 scale GAD-7 and the Child PTSD Symptom Scale for DSM-5 CPSS-5 Adolescents will be recruited from middle schools and randomly assigned to one of three groups a psychoeducation b psychoeducation emotional skills enhancement or c psychoeducation emotional skills enhancement positive childhood experience promotion The school-based intervention will consist of 4-8 sessions with assessments conducted at baseline post-treatment and a 3-month follow-up Investigators will conduct multilevel models MLMs and structural equation models SEMs to investigate the impact of Adverse Childhood Experiences ACEs Positive Childhood Experiences PCEs alexithymia and emotion regulation abilities on mental health outcomes in adolescents
Detailed Description:
None
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