Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype

Study Overview
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Brief Summary
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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.

Official Title
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Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype

Conditions
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Neurofibromatoses

Intervention / Treatment
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* Behavioral: Stress Management Group 1
* Behavioral: Stress Management Group 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be between the ages of 12 and 17 Can read and speak English at or above the 6th grade level Diagnosis of neurofibromatosis type 1 or neurofibromatosis type 2 by a specialized medical provider Exclusion Criteria: 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) Recent (within past 3 months) change in antidepressant medication Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months Unable or unwilling to sign the informed consent documents Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress Management Group 1<br>Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques. | Behavioral: Stress Management Group 1<br>* Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.<br>|
| Experimental: Stress Management Group 2<br>Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques. | Behavioral: Stress Management Group 2<br>* Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (WHO-QOLBREFadol) | Measures quality of life | Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale (PSS-10) | Situations in one's life over the past month/week are appraised as stressful | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| The Pain Catastrophizing Scale - Child Version (PCS-C) | Measures how individuals experience pain | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Patient Health Questionnaire for Adolescents (PHQ-A) | Symptoms of depression and functional impairment | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Pain Interference Index (PII) | How much pain has interfered with their life | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Child and Adolescent Mindfulness Measure (CAMM) | Assesses mindfulness in children and adolescents | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Interpersonal Reactivity Index (IRI) | Assesses the cognitive and affective dimensions of empathy | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Epworth Sleepiness Scale-Revised for Children (ESS) | Measures how likely one is to doze off or sleep in certain situations | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Gratitude Questionnaire Six-Item Form (GQ-6) | Assesses individual differences in the proneness to experience gratitude in daily life | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Life Orientation Test (LOT) Optimism Scale | Individual differences in generalized optimism versus pessimism | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp) | Spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| MOS (Support/Empathy) | Measures recent thinking about the various dimensions of social support. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Measure of Current Status (MOCS) Part A | Measures participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Generalized Anxiety Disorder 7-item (GAD-7) scale | A brief measure for assessing generalized anxiety disorder | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Quality of Life (WHOQOL-BREF) | The WHOQOL-BREF comprises of 26 items which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Satisfaction with life adolescent | measures global satisfaction with life | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |