Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06330779
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-07
Brief Title:
Trauma-adapted Yoga in Child Adolescent Psychiatry
Sponsor:
University West Sweden
Organization:
University West Sweden
Study Overview
Official Title:
Trauma-adapted Yoga in Child Adolescent Psychiatry A Multicenter Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
TAY-CAP
Brief Summary:
The goal of this randomized clinical trial is to evaluate the efficacy of trauma-adapted yoga as a complementary intervention to care as usual in child and adolescents psychiatry clinics in the population of adolescents with the diagnosis of ADHD andor PTSD We hypothesize that trauma-adapted yoga TAY is an effective non-pharmacological intervention for adolescent with ADHD andor PTSD Aims 1 Validate the impact of TAY on the mental health quality of life of adolescents with ADHD andor PTSD 2 Investigate the feasibility of online TAY for continued self-care 3 Explore adolescents experiences parental perspectives on TAY in their treatment 4 Explore healthcare professionals experience on the integration of TAY into clinical practice
Within and between group yoga group vs waiting list analyses will be performed
Within and between group yoga group vs waiting list analyses will be performed
Detailed Description:
Study Summary
Introduction
There is growing interest in applying yoga and mindfulness techniques to children and adolescents although research in this area remains limited Existing studies suggest that yoga can reduce stress improve mood enhance resilience and boost self-regulation skills in school settings Additionally these approaches hold promise for improving mental health in clinical child and adolescent populations
Study Aim
The aim of this study is to evaluate the impact of trauma-adapted yoga TAY as a complement to care as usual in Child and Adolescent Psychiatry CAP clinics in the USA and Sweden The study hypothesizes that eight weeks of TAY practice will reduce negative affect states and pain intensityfrequency while improving emotional and behavioral control attention and resilience It is expected that TAY will enhance the success of other ongoing treatments in CAP foster improved well-being and provide patients with self-care tools
Importance of the Study
The studys results are crucial for developing evidence-based care for children and adolescents with mental disorders and filling gaps in knowledge about yogas efficacy as a treatment method
Participants
Adolescents aged 12-18 in contact with CAP clinics who have received a diagnosis of PTSD andor ADHD are eligible Inclusion criteria include understanding English or Swedish while exclusion criteria involve ongoing substance use active manic periods psychotic disorders suicidality cognitive impairment and serious physical illnesses
Study Design
The study adopts a Randomized Control Trial RCT design Participants undergo pre-intervention assessment followed by random assignment to either the yoga group or a control group The yoga group attends weekly TAY sessions for eight weeks while the control group waits Assessments are conducted post-intervention and at a follow-up point The study aims to include 174-180 adolescents
Intervention
TAY classes span eight weeks incorporating physical movements balance exercises adapted breathing practices trauma-informed mindfulness guidance and guided progressive muscle relaxation Participants have the option to continue yoga practice online after the intervention
Assessment
Assessment includes self-reported measures using validated instruments such as the Child PTSD Symptom Scale PositiveNegative Affect Pain assessment Child and Youth Resilience Measure and Self-Directedness Guardian-reported measures include the SNAP-IV and PedsQL-Fam inventory Patient records provide additional data
Qualitative Component
After the intervention individual interviews gather qualitative information on participants guardians and staffs experiences of yoga and its health effects
This study aims to provide valuable insights into the potential benefits of trauma-adapted yoga for adolescents in CAP clinics contributing to the advancement of evidence-based care in this population
Introduction
There is growing interest in applying yoga and mindfulness techniques to children and adolescents although research in this area remains limited Existing studies suggest that yoga can reduce stress improve mood enhance resilience and boost self-regulation skills in school settings Additionally these approaches hold promise for improving mental health in clinical child and adolescent populations
Study Aim
The aim of this study is to evaluate the impact of trauma-adapted yoga TAY as a complement to care as usual in Child and Adolescent Psychiatry CAP clinics in the USA and Sweden The study hypothesizes that eight weeks of TAY practice will reduce negative affect states and pain intensityfrequency while improving emotional and behavioral control attention and resilience It is expected that TAY will enhance the success of other ongoing treatments in CAP foster improved well-being and provide patients with self-care tools
Importance of the Study
The studys results are crucial for developing evidence-based care for children and adolescents with mental disorders and filling gaps in knowledge about yogas efficacy as a treatment method
Participants
Adolescents aged 12-18 in contact with CAP clinics who have received a diagnosis of PTSD andor ADHD are eligible Inclusion criteria include understanding English or Swedish while exclusion criteria involve ongoing substance use active manic periods psychotic disorders suicidality cognitive impairment and serious physical illnesses
Study Design
The study adopts a Randomized Control Trial RCT design Participants undergo pre-intervention assessment followed by random assignment to either the yoga group or a control group The yoga group attends weekly TAY sessions for eight weeks while the control group waits Assessments are conducted post-intervention and at a follow-up point The study aims to include 174-180 adolescents
Intervention
TAY classes span eight weeks incorporating physical movements balance exercises adapted breathing practices trauma-informed mindfulness guidance and guided progressive muscle relaxation Participants have the option to continue yoga practice online after the intervention
Assessment
Assessment includes self-reported measures using validated instruments such as the Child PTSD Symptom Scale PositiveNegative Affect Pain assessment Child and Youth Resilience Measure and Self-Directedness Guardian-reported measures include the SNAP-IV and PedsQL-Fam inventory Patient records provide additional data
Qualitative Component
After the intervention individual interviews gather qualitative information on participants guardians and staffs experiences of yoga and its health effects
This study aims to provide valuable insights into the potential benefits of trauma-adapted yoga for adolescents in CAP clinics contributing to the advancement of evidence-based care in this population
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