Trauma-adapted Yoga in Child & Adolescent Psychiatry.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorUniversity West, Sweden

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adolescents who have received a diagnosis (not under evaluation) of PTSD and/or ADHD

Understanding English or Swedish languages.

Disqualifiers

Ongoing substance use,

active manic periods,

psychotic disorders,

suicidality,

Trial design

Design model

Crossover

Treatments tested in this trial

  • Trauma-adapted yoga

    Other intervention

    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 awareness. Each yoga session follows a structured sequence of activities designed to promote participants' well-being and physiological awareness. Online TAY classes After eight weeks, adolescents in the yoga group can continue their practice online. Exclusive to previous in-person participants, they'll receive a link for recorded classes and they will have the possibility to contact their health care contact any time.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Yoga-groupExperimental treatment 1 intervention
Group B: ControllNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Negative experience score CPSS-5-S

Child PTSD Symptom Scale: 27-item self-report version rates each item from 0 (not at all) to 4 (6 or more times a week/almost always) based on the frequency and severity of the reported symptom experienced during the last month. The total severity score ranges from 0 to 80 and is calculated by summing the ratings of the first 20 items. The CPSS-5 also yields subscale scores for intrusion (Items 1-5), avoidance (Items 6-7), changes in cognition and mood (Items 8-14), and increased arousal and reactivity (Items15-20). Finally, seven items assess impairment of endorsed symptoms on daily functioning pertinent to youth (e.g., fun things you want to do, doing your chores, relationships with your friends). The respondent rates these items on a scale of 0 (not at all) to 4 (6 or more times a week/almost always), resulting in an impairment score that ranges from 0 to 28.

Time frame
8 weeks
2

Inattention, impulsivity score

Parent-rated ADHD score, SNAP-IV: The SNAP-IV consists of a total of 26 questions, divided into two subscales: one for inattention symptoms and one for hyperactivity-impulsivity symptoms. Each subscale contains 9 items, and there are 8 additional questions that provide an overall assessment of impairment. Higher score indicates higher problem load.

Time frame
8 weeks
3

Resilience score

social, ecological, psychological, and emotional resilience: The Child and Youth Resilience Measure-Revised-Adapted Swedish (CYRM-R-AS) is a self-report measures of social ecological and psychological, emotional resilience. In addition to an overall score of resilience, scores can be derived for the three subscales of the measures personal, caregiver and psychological/emotional resilience. The CYRM-R (simplified) is suitable for youth aged 10-23 with difficulties to comprehend text or sustain attention. Its 23 items can be scored on 3- point Likert scales. The items in the measure are all positively worded and therefore scoring involves simple summing of responses. It can be used to evaluate the efficacy of interventions to build and maintain resilience. Three sub-scales can be created . Higher scores indicate better outcome.

Time frame
8 weeks

Secondary outcomes

1

Pain frequency and intensity

Pain frequency, intensity and location: The Pain assessment instrument uses verbal and numerical assessment scales, where the participant describes their pain during the last month using words (no pain; mild pain; moderate pain; severe pain; very severe pain; unbearable pain) and using numbers between 0 and 10, where 0 (zero) represents no pain, and 10 represents the worst possible pain. Primary and secondary pain localization is described in free text by the participant. Higher scores indicate increased problem load

Time frame
8 weeks
2

affect

Positive and Negative affect state: The Positive Affect and Negative Affect-Extended (PANAS-X) instrument consists of 30 items and captures the valence (positive and negative) and the arousal (high or low) of the mood descriptors during the last month. The following are examples for all four categories. Positive activated: active, enthusiastic, excited, inspired, and proud; Positive deactivated: at ease, serene, calm, relaxed, and content; Negative activated: afraid, scared, hostile, guilty, and ashamed; Negative deactivated: tired, sluggish, drowsy, dull, and bored. HIgher scores indicate dominance of the specific subscale in affect state.

Time frame
8 weeks
3

Self-directednes

Self-control, responsibility: Self-Directedness character domain of the J-TCI (Junior Temperament and Character Inventory, Cloninger et al., Swedish version: Kerekes et al.) has been used to measure changes in this domain during the last month. Has been used for 9-15-year-old adolescents in Sweden. Self-directedness, or self-determination, refers to a tendency to achieve personal goals and values. Includes 20 questions and dichotomic responses (Yes/No). Higher scores indicate better outcome.

Time frame
8 weeks
4

Quality of life score

PedsQL and PedsQL FIM: The 23-item PedsQL™ 4.0 Generic Core Scales encompass: * 1\) Physical Functioning (8 items), * 2\) Emotional Functioning (5 items), * 3\) Social Functioning (5 items), and * 4\) School Functioning (5 items), and were developed through focus groups, cognitive interviews, pre-testing, and field-testing measurement development protocols. The Parent-reported Health-Related Quality of Life of the Child (PedsQL-Fam) inventory is an assessment tool designed to measure the health-related quality of life (HRQOL) of children from the perspective of their parents or caregivers. It includes questions about different aspects of the child's functioning and well-being, 25 items. Higher scores indicate better outcome

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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University West, Sweden

Lead sponsor

Vastra Gotaland Region

Collaborator

Healthcare Region Dalarna

Collaborator