Clinical trial NCT06988800: Musically-Guided Paced Breathing Intervention Improves Mental Health in War-Affected Adolescents: A Randomized Trial
Official title: A Randomized Controlled Trial Examining the Impact of a Guided Paced Breathing Audiovisual Intervention on Psychosocial Functioning in Palestinian Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Self-Efficacy
Depression Not Otherwise Specified
Lead sponsor: Muvik Labs
Sponsor class: INDUSTRY
Collaborators: name: MECI
First posted: 2025-05-25
Enrollment: 220
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Examine the impact of a mindfulness condition, a guided paced breathing audiovisual intervention condition, and a guided paced breathing audiovisual intervention plus take-home application condition compared to a matched control condition on anxiety symptoms.

Detailed description: 3. Methodology: Sample and population

Individuals will be eligible if they attend the after-school program in Palestine through the Middle East Children's Institute (MECI) and are in grades 9-12. The MECI after school program is a free enrichment service provided to Palestinian youth at no charge. The activities include healthy meals, psychosocial support, creative art, sports, and drama.

Study setting The Middle East Children's Institute after-school program in Palestine.

Recruitment All eligible adolescents will be given information about the study (including that it is optional and voluntary) and provided with a consent form to bring home to their parents. They will be told that the first 184 individuals who return the signed and completed consent form will be enrolled into the study. Study staff will follow-up with the families of potentially eligible adolescents up to three times to ask if they have questions about the study and/or to remind them to return the signed consent form if they would like to participate.

Study duration Each intervention will have 16 to 24 sessions, delivered 2 times a week for 8 to 12 weeks in a group format in school classrooms. Each group will consist of approximately 10 adolescents, and each intervention will have a duration of approximately less than 10 minutes long. In the session where they are collected, questionnaire completion should take approximately 20 minutes. Multiple sessions will be necessary to complete all assessments before and after the intervention.

Data collection and tools

There will be several non-invasive survey instruments utilized in this study. These final versions of the instruments are undergoing finalization, but detailed examples of these instruments are described below. Additional instruments may be utilized.

Demographics. At baseline, participants will complete an investigator-developed self-report questionnaire that asks about participant age and gender identity.

Anxiety. As the primary outcomes measure, participants will complete the Revised Children's Manifest Anxiety Scale (RCMAS) self-report questionnaire (Reynolds \& Richmond, 1985). The RCMAS lists 37 feelings or actions and participants respond "yes" if that item is typical of their own feelings/actions, or "no" if not. The RCMAS produces a total anxiety score and three subscales: physiological anxiety, worry/oversensitivity, and social concerns/concentration. The Arabic version of the RCMAS has shown to have acceptable reliability and validity in youth (Al Jabery \& Arabiat, 2011).

Self-Efficacy As a secondary outcome measure, a translated version of the Self-Efficacy Questionnaire for Children (SEQ-C) will be used. The SEQ-C includes three 8-item scales that measure academic, social, and emotional self-efficacy. The academic self-efficacy scale includes questions about the person's perception of achieving academic goals. The social self-efficacy scale addresses social challenges, and the emotional self-efficacy scale includes questions about coping with unpleasant problems or events.

Resiliency. As a secondary outcome measure, youth resilience will be assessed. The Child and Youth Resilience Measure (CYRM) measure is not specific to this study. It is a tool that the MECI team uses to evaluate the overall program impact. The details on the tool can be found here: https://cyrm.resilienceresearch.org/ Session state measures. As a secondary outcome, an acute in session measure of physiological arousal will be assessed. Before and after each session, all participants will complete brief items asking how tense, worried, calm, and relaxed they are "right now." The participant will rate each item on a 4-point Likert scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = strongly. Two bilingual members of the study staff will collaboratively translate these items from English to Arabic to eliminate any discrepancies in translation and ensure cultural equivalence. A third independent bilingual individual will then back-translate the items into English in order to compare these items with the original constructs. The process will be repeated as necessary to refine the translated items.

Trained psychologists will administer all baseline and outcome assessments. At each time point, psychologists will distribute the questionnaires to all participants and ensure no participants have any questions. After the participant has returned the questionnaires to the psychologists, they will confirm: 1) all items on the questionnaires have been completed, unless the participant has intentionally left an item blank, and 2) there is no identifying information on the questionnaire. Importantly, a specific coding system will be applied and each of the questionnaires will have a specific code. The psychologists will be not be blinded to group assignment.

Facilitators will collect the in-session measures (positive/negative affect and relaxation ratings) from all participants before and after each session. After the participant has returned the questionnaires to the facilitators, they will confirm: 1) all items on the questionnaires have been completed, unless the participant has intentionally left an item blank, and 2) there is no identifying information on the questionnaire and only a deidentified code for each participant. The facilitators will not be blinded to group assignment.

At the end of each week, all de-identified data collection sheets will be scanned by staff at MECI and sent to Muvik at vic@muviklabs.io. The de-identified data collection sheets will be stored in the study's data folder on Google Drive. The data will then be independently double-entered into two separate datasets by two Muvik staff members. These staff members will not have access to any identifying information. At least once per month, the two datasets will be reconciled and any data discrepancies will be resolved by the study team.

Incentives for participants

Participants will receive no financial or other compensation.

Eligibility criteria: Inclusion Criteria:

Participating in MECI after school program and between the ages of 13 and 17.

Exclusion Criteria:

Not participating in MECI after school program or outside of the ages of 13 and 17.

Primary outcomes:
measure: Revised Children's Manifest Anxiety Scale (RCMAS)
timeFrame: From enrollment to the end of treatment at 10 weeks
measure: Self-Efficacy Questionnaire for Children (SEQ-C)
timeFrame: From enrollment to the end of treatment at 10 weeks
measure: PHQ-9
timeFrame: From enrollment to the end of treatment at 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Deir Ghassaneh
country: Palestinian Territory, occupied
facility: MECI
state: West Bank
Study officials:
affiliation: Muvik Labs
name: Chelsea Gordon, PhD
role: STUDY_DIRECTOR
References: