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Recruiting NCT06330779

Trauma-adapted Yoga in Child & Adolescent Psychiatry.

No phase Interventional ADHD PTSD Quality of Life Self-Control

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trauma-adapted yoga.
Who it may be relevant to
Registry conditions: ADHD, PTSD, Quality of Life, Self-Control. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Trauma-adapted Yoga in Child & Adolescent Psychiatry: A Multicenter Study.

Overview

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.

Interventions

  • Other Trauma-adapted yoga
    Trauma-adapted-yoga (TAY) classes The classes, which span eight weeks with a once-a-week frequency, each last approximately 45-50 minutes. These small group classes are structured in a semi-circle arrangement to create a sense of security and empowerment for the participants. The teaching approach is trauma-sensitive, characterized by its inviting nature, provision of choices when facing challenges (A-B choices), and direction toward tangible physical sensations to enhance interoceptive awarenes

Primary outcome measures

  • Negative experience score CPSS-5-S [Time frame: 8 weeks]
  • Inattention, impulsivity score [Time frame: 8 weeks]
  • Resilience score [Time frame: 8 weeks]
Secondary outcome measures (4)
  • Pain frequency and intensity [Time frame: 8 weeks]
  • affect [Time frame: 8 weeks]
  • Self-directednes [Time frame: 8 weeks]
  • Quality of life score [Time frame: 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Supportive care

Study locations

Sweden · 1 center
  • Queen Sylvia Child Hospital , CAP — Gothenburg

Identifiers

NCT: NCT06330779 · UWest

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗