Clinical trial NCT06330779: Trauma-adapted Yoga in Child & Adolescent Psychiatry.
Official title: Trauma-adapted Yoga in Child & Adolescent Psychiatry: a Multicenter Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
PTSD
Quality of Life
Self-Control
Pain
Affect
Lead sponsor: University West, Sweden
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
name: Healthcare Region Dalarna
First posted: 2024-03-26
Enrollment: 180
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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 and/or PTSD. We hypothesize that trauma-adapted yoga (TAY) is an effective non-pharmacological intervention for adolescent with ADHD and/or PTSD. Aims: (1) Validate the impact of TAY on the mental health \& quality of life of adolescents with ADHD and/or 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.

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 intensity/frequency, 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 study's results are crucial for developing evidence-based care for children and adolescents with mental disorders and filling gaps in knowledge about yoga's efficacy as a treatment method.

Participants:

Adolescents aged 12-18 in contact with CAP clinics who have received a diagnosis of PTSD and/or 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, Positive/Negative 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 staff's 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.

Eligibility criteria: Inclusion Criteria:

* Adolescents who have received a diagnosis (not under evaluation) of PTSD and/or ADHD
* Understanding English or Swedish languages.

Exclusion Criteria:

* Ongoing substance use,
* active manic periods,
* psychotic disorders,
* suicidality,
* cognitive impairment.
* serious physical illness prohibiting participation in physical activities.

Primary outcomes:
measure: Negative experience score CPSS-5-S
timeFrame: 8 weeks
measure: Inattention, impulsivity score
timeFrame: 8 weeks
measure: Resilience score
timeFrame: 8 weeks
Secondary outcomes:
measure: Pain frequency and intensity
timeFrame: 8 weeks
measure: affect
timeFrame: 8 weeks
measure: Self-directednes
timeFrame: 8 weeks
measure: Quality of life score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Queen Sylvia Child Hospital , CAP
Study officials:
References: