Neurofibromatoses
Conditions
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.
Interventions
BEHAVIORALStress Management Group 1
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
BEHAVIORALStress Management Group 2
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Sponsors
The Children's Tumor Foundation
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (WHO-QOLBREFadol) | Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36) | Measures quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale-Revised for Children (ESS) | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | Measures how likely one is to doze off or sleep in certain situations |
| Measure of Current Status (MOCS) Part A | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 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. |
| Generalized Anxiety Disorder 7-item (GAD-7) scale | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | A brief measure for assessing generalized anxiety disorder |
| Quality of Life (WHOQOL-BREF) | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 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. |
| Satisfaction with life adolescent | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | measures global satisfaction with life |
| Perceived Stress Scale (PSS-10) | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | Situations in one's life over the past month/week are appraised as stressful |
| The Pain Catastrophizing Scale - Child Version (PCS-C) | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | Measures how individuals experience pain |
| Patient Health Questionnaire for Adolescents (PHQ-A) | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | Symptoms of depression and functional impairment |
| Pain Interference Index (PII) | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | How much pain has interfered with their life |
| Child and Adolescent Mindfulness Measure (CAMM) | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | Assesses mindfulness in children and adolescents |
| Interpersonal Reactivity Index (IRI) | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | Assesses the cognitive and affective dimensions of empathy |
| Gratitude Questionnaire Six-Item Form (GQ-6) | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | Assesses individual differences in the proneness to experience gratitude in daily life |
| Life Orientation Test (LOT) Optimism Scale | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | Individual differences in generalized optimism versus pessimism |
| Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp) | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | Spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days |
| MOS (Support/Empathy) | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | Measures recent thinking about the various dimensions of social support. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intent to Attend | Baseline (week 0) | Measures how likely and how motivated the participants is to attend the next session. |
| Participant Feedback - Program Satisfaction Questionnaire | Post-intervention (week 8) | Measures how satisfied the participant is with the intervention |
| Demographics | Baseline (week 0) | Basic demographics |
| Expectancy Questionnaire | Baseline (week 0) | Measures how much the participant believes the intervention will work |
Countries
United States
Outcome results
None listed