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A Randomized Controlled Trial Examining the Impact of a Guided Paced Breathing Audiovisual Intervention on Psychosocial Functioning in Palestinian Adolescents
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.
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. 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 14 sessions, delivered 2 times a week for 5 weeks in a group format in school classrooms, and an additional 2 weeks following a one month Ramadan period with no intervention delivered. Each group will consist of approximately 10 adolescents, and each intervention will have a duration of approximately less than 10 minutes long. 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. 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. 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. 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. Depression. As a secondary outcome measure, depression will be measured by the translated PHQ (Patient Health Questionnaire) -9. Incentives for participants Participants will receive no financial or other compensation.
Age
13 - 17 years
Sex
ALL
Healthy Volunteers
Yes
MECI
Deir Ghassaneh, West Bank, Palestinian Territories
Start Date
January 21, 2024
Primary Completion Date
May 9, 2024
Completion Date
May 9, 2024
Last Updated
October 14, 2025
213
ACTUAL participants
Paced breathing wellness breathing sessions
DEVICE
Mindfulness video sessions
DEVICE
Lead Sponsor
Muvik Labs
Collaborators
NCT07478393
NCT07456631
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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