Clinical trial NCT02387177: Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype
Official title: Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurofibromatoses
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: The Children's Tumor Foundation
First posted: 2015-03-12
Enrollment: 51
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this research is to adapt the NF-specific adult version of the Skype 3RP for use with adolescents, and to test its feasibility, acceptability, and preliminary effect in improving quality of life, and in decreasing stress and psychological distress.


Eligibility criteria: Inclusion Criteria:

1. Must be between the ages of 12 and 17
2. Can read and speak English at or above the 6th grade level
3. Diagnosis of neurofibromatosis type 1 or neurofibromatosis type 2 by a specialized medical provider

Exclusion Criteria:

1. Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality)
2. Recent (within past 3 months) change in antidepressant medication
3. Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months
4. Unable or unwilling to sign the informed consent documents
5. Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype

Primary outcomes:
measure: Quality of life (WHO-QOLBREFadol)
timeFrame: Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36)
Secondary outcomes:
measure: Perceived Stress Scale (PSS-10)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: The Pain Catastrophizing Scale - Child Version (PCS-C)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Patient Health Questionnaire for Adolescents (PHQ-A)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Pain Interference Index (PII)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Child and Adolescent Mindfulness Measure (CAMM)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Interpersonal Reactivity Index (IRI)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Epworth Sleepiness Scale-Revised for Children (ESS)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Gratitude Questionnaire Six-Item Form (GQ-6)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Life Orientation Test (LOT) Optimism Scale
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: MOS (Support/Empathy)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Measure of Current Status (MOCS) Part A
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Generalized Anxiety Disorder 7-item (GAD-7) scale
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Quality of Life (WHOQOL-BREF)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Satisfaction with life adolescent
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Other outcomes:
measure: Demographics
timeFrame: Baseline (week 0)
measure: Expectancy Questionnaire
timeFrame: Baseline (week 0)
measure: Intent to Attend
timeFrame: Baseline (week 0)
measure: Participant Feedback - Program Satisfaction Questionnaire
timeFrame: Post-intervention (week 8)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maira Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References: