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Communitas: A Program for Teens Living With Chronic Illness and Their Families

Effectiveness of a Mind-Body and Peer Support Program for Teens Living With Chronic Illness and Their Parents: A Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03170167
Enrollment
88
Registered
2017-05-30
Start date
2016-10-01
Completion date
2019-09-04
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Illness

Brief summary

The proposed pilot study is an evaluation of Communitas, a mind-body skills group visit and for 12-19 year-olds living with chronic physical illness. The goal of this study is to assess the efficacy and feasibility of these group visits. During 2017-2018, the investigators will recruit 50-100 patient and 50-100 parent enrollees of Communitas to participate in this study. The study will be a pre-post evaluation, without a control group, using validated patient-report assessments at baseline, after completion of the group visits, and 3 months later. The primary outcome variables will be physical and mental wellbeing, stress, mood, resilience, mindfulness, and social support. Paired t tests will be used to assess changes from baseline to immediately post-intervention & 3 months post-intervention. The investigators will also calculate Cohen's d effect sizes, to help them understand the degree to which an effect is present in the population.

Detailed description

The Communitas pilot study is a survey study of Communitas, a pre-existing integrative medicine and mind-body skills group visit for adolescents living with chronic illness and their parents. The goal of this study is to evaluate the preliminary efficacy and feasibility for these group visits. Approximately 50-100 patients and 50-100 parent enrollees of the Communitas group visits will be recruited to participate in this survey study optionally. During the group visits, both the patient and parent groups will learn about and experience various coping, self-care, pain and stress-reduction modalities, participate in group sharing to promote engagement with a diagnosis and provide emotional support, and benefit from facilitated discussions about some of the more practical aspects of living with chronic illness. The group visits will be offered to patients and their parents as clinical service, regardless of enrollment in the survey study, and will be billed to insurance as consult group visit with the pediatrician. The group visits will be held at both the Osher Center for Integrative Medicine and Mission Bay Children's Hospital and will be led by a pediatrician, starting in October 2016. The study will be set up as a pre-post evaluation, without a control group, using patient-report and parent-report qualitative and quantitative assessments at baseline, after completion of the series of group visits, and 3 months later. In addition, some families may be asked if they would like to participate in a videotaped interview before and after the start of the program.

Interventions

None listed

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* Enrolled in the Communitas group visit at the UCSF Osher Center for Integrative Medicine or Mission Bay Children's Hospital. * Patients enrolled in these group visits are males and females 12-20 years of age and living with a chronic illness.

Exclusion criteria

* People who are not enrolled in the Communitas group visit at the UCSF Osher Center for Integrative Medicine or Mission Bay Children's Hospital will be excluded from this survey study. * The Communitas group consists of a patient group of young people ages 12-20 living with chronic illness, as well as a parent group.

Design outcomes

Primary

MeasureTime frameDescription
Physical wellbeingChange from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 monthsNIH Promis Global Health instrument summary score
Mental wellbeingChange from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 monthsNIH Promis Global Health instrument summary score
Perceived StressChange from baseline Perceived stress scale summary score at 2 months, and at 5 monthsPerceived stress scale summary score
Mood: TensionChange from baseline Profile of Mood States Tension instrument subscale score at 2 months and at 5 monthsProfile of Mood States Tension instrument subscale score
ResilienceChange from baseline 14-Item Resilience Scale summary score at 2 months and at 5 months14-Item Resilience Scale summary score
Social supportChange from baseline Social Support Scale summary score at 2 months, and at 5 monthsSocial Support Scale summary score
MindfulnessChange from baseline Mindful Attention Awareness Scale summary score at 2 months, and at 5 monthsMindful Attention Awareness Scale summary score
Mood: AngerChange from baseline Profile of Mood States Anger instrument sub scale score at 2 months, and at 5 monthsProfile of Mood States Anger instrument subscale score
Mood: DepressionChange from baseline Profile of Mood States Depression instrument sub scale score at 2 months, and at 5 monthsProfile of Mood States Depression instrument subscale score
Mood: FatigueChange from baseline Profile of Mood States Fatigue instrument sub scale score at 2 months, and at 5 monthsProfile of Mood States Fatigue instrument subscale score

Secondary

MeasureTime frameDescription
Self-reported adherence, using Medical Outcomes Study General Adherence scaleChange from baseline Medical Outcomes Study General Adherence instrument summary score at 2 months, and at 5 monthsMedical Outcomes Study General Adherence instrument summary score
pain medicine usage in past monthChange from baseline pain medicine usage in past month likert scale at 2 months, and at 5 monthslikert scale
number visits to emergency department in past monthChange from baseline number visits to emergency department in past month at 2 months, and at 5 months

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORFrederick M Hecht, MD

UCSF Osher Center for Integrative Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026