Clinical trial NCT03170167: Communitas: A Program for Teens Living With Chronic Illness and Their Families
Official title: Effectiveness of a Mind-Body and Peer Support Program for Teens Living With Chronic Illness and Their Parents: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Illness
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 12-20 year-old pediatric patients who are living with a chronic physical illness and who are enrolled in the Communitas group visit at the UCSF Osher Center for Integrative Medicine or Mission Bay Children's Hospital, along with their willing and available guardian(s).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical wellbeing
timeFrame: Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months
measure: Mental wellbeing
timeFrame: Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months
measure: Perceived Stress
timeFrame: Change from baseline Perceived stress scale summary score at 2 months, and at 5 months
measure: Mood: Tension
timeFrame: Change from baseline Profile of Mood States Tension instrument subscale score at 2 months and at 5 months
measure: Resilience
timeFrame: Change from baseline 14-Item Resilience Scale summary score at 2 months and at 5 months
measure: Social support
timeFrame: Change from baseline Social Support Scale summary score at 2 months, and at 5 months
measure: Mindfulness
timeFrame: Change from baseline Mindful Attention Awareness Scale summary score at 2 months, and at 5 months
measure: Mood: Anger
timeFrame: Change from baseline Profile of Mood States Anger instrument sub scale score at 2 months, and at 5 months
measure: Mood: Depression
timeFrame: Change from baseline Profile of Mood States Depression instrument sub scale score at 2 months, and at 5 months
measure: Mood: Fatigue
timeFrame: Change from baseline Profile of Mood States Fatigue instrument sub scale score at 2 months, and at 5 months
Secondary outcomes:
measure: Self-reported adherence, using Medical Outcomes Study General Adherence scale
timeFrame: Change from baseline Medical Outcomes Study General Adherence instrument summary score at 2 months, and at 5 months
measure: pain medicine usage in past month
timeFrame: Change from baseline pain medicine usage in past month likert scale at 2 months, and at 5 months
measure: number visits to emergency department in past month
timeFrame: Change from baseline number visits to emergency department in past month at 2 months, and at 5 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: UCSF Osher Center for Integrative Medicine
name: Frederick M Hecht, MD
role: PRINCIPAL_INVESTIGATOR
References: