Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550778
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Construction and Preliminary Application of Mindfulness-based Emotional Regulation Intervention Scheme for Adolescents With Anxiety Disorder and Caregivers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ethics Committee of Daqing Campus of Harbin Medical University
Status:
COMPLETED
Status Verified Date:
2024-08
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:
PurposeAiming to improve the emotional regulation abilities of adolescents with AD and caregivers reduce anxiety levels and play an important role in promoting the recovery of adolescents with AD and the mental and physical health of parents
MethodsThis study is divided into two parts In Part One a mindfulness-based emotional regulation intervention program for adolescents with anxiety disorders and their caregivers was developed Drawing on family systems theory the mindfulness coping model and Grosss emotion regulation process model a systematic literature review was conducted to extract the main contents of the intervention program Semi-structured interviews were conducted with 11 pairs of adolescents with AD and their caregivers to identify emotional regulation issues and intervention needs forming a preliminary draft of the mindfulness-based emotional regulation intervention program for adolescents with anxiety disorders and their caregivers Fifteen experts were invited to participate in Delphi consultations and based on pre-experimental feedback the intervention program was further refined to produce a pilot intervention protocol
In Part Two the feasibility and effectiveness of the mindfulness-based emotional regulation intervention for adolescents with anxiety disorders and their caregivers were preliminarily assessed Using a randomized controlled trial design 78 pairs of adolescents with AD and their caregivers who met the inclusion criteria were selected from the Children and Adolescent Psychological Unit at the Third Hospital of Daqing City Heilongjiang Province They were randomly assigned to either the intervention group n39 pairs receiving a 6-week mindfulness-based emotional regulation intervention or the control group n39 pairs receiving routine hospital care During the intervention period 4 adolescents with AD and 5 caregivers withdrew from the intervention group while 2 adolescents with AD and 3 caregivers withdrew from the control group Assessments were conducted at baseline T0 immediately post-intervention T1 and one month post-intervention T2 using the Emotion Regulation Questionnaire ERQ Self-Rating Anxiety Scale Mindful Attention Awareness Scale MAAS Ruminative Responses Scale RRS and Mindfulness in Parenting Questionnaire MIPQ for both adolescents with AD and their caregivers Data were analyzed using SPSS 260 employing descriptive statistics t-tests chi-square tests Mann-Whitney U tests and generalized estimating equations to compare the intervention effects
MethodsThis study is divided into two parts In Part One a mindfulness-based emotional regulation intervention program for adolescents with anxiety disorders and their caregivers was developed Drawing on family systems theory the mindfulness coping model and Grosss emotion regulation process model a systematic literature review was conducted to extract the main contents of the intervention program Semi-structured interviews were conducted with 11 pairs of adolescents with AD and their caregivers to identify emotional regulation issues and intervention needs forming a preliminary draft of the mindfulness-based emotional regulation intervention program for adolescents with anxiety disorders and their caregivers Fifteen experts were invited to participate in Delphi consultations and based on pre-experimental feedback the intervention program was further refined to produce a pilot intervention protocol
In Part Two the feasibility and effectiveness of the mindfulness-based emotional regulation intervention for adolescents with anxiety disorders and their caregivers were preliminarily assessed Using a randomized controlled trial design 78 pairs of adolescents with AD and their caregivers who met the inclusion criteria were selected from the Children and Adolescent Psychological Unit at the Third Hospital of Daqing City Heilongjiang Province They were randomly assigned to either the intervention group n39 pairs receiving a 6-week mindfulness-based emotional regulation intervention or the control group n39 pairs receiving routine hospital care During the intervention period 4 adolescents with AD and 5 caregivers withdrew from the intervention group while 2 adolescents with AD and 3 caregivers withdrew from the control group Assessments were conducted at baseline T0 immediately post-intervention T1 and one month post-intervention T2 using the Emotion Regulation Questionnaire ERQ Self-Rating Anxiety Scale Mindful Attention Awareness Scale MAAS Ruminative Responses Scale RRS and Mindfulness in Parenting Questionnaire MIPQ for both adolescents with AD and their caregivers Data were analyzed using SPSS 260 employing descriptive statistics t-tests chi-square tests Mann-Whitney U tests and generalized estimating equations to compare the intervention effects
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