Clinical Trial: Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome:

• The 14-Item Resiliency Scale (RS-14) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Measures stress coping ability in the face of adversity
• Quality of life (WHO-QOLBREFadol) [ Time Frame: Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36) ]
  Measures quality of life

Original Primary Outcome:

• Satisfaction With Life Scale (SWL-Child) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Measures global cognitive judgements of satisfaction with one's life
• The 14-Item Resiliency Scale (RS-14) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Measures stress coping ability in the face of adversity

Current Secondary Outcome:

• Perceived Stress Scale (PSS-10) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Symptoms of depression and functional impairment
• Pain Interference Index (PII) [ Time Frame: 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) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Assesses mindfulness in children and adolescents
• Interpersonal Reactivity Index (IRI) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Assesses the cognitive and affective dimensions of empathy
• Epworth Sleepiness Scale—Revised for Children (ESS) [ Time Frame: 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
• Gratitude Questionnaire Six-Item Form (GQ-6) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Measures recent thinking about the various dimensions of social support.
• Measure of Current Status (MOCS) Part A [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  measures global satisfaction with life

Original Secondary Outcome:

• Perceived Stress Scale (PSS-10) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Symptoms of depression and functional impairment
• Pain Interference Index (PII) [ Time Frame: 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) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Assesses mindfulness in children and adolescents
• Interpersonal Reactivity Index (IRI) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Assesses the cognitive and affective dimensions of empathy
• Epworth Sleepiness Scale—Revised for Children (ESS) [ Time Frame: 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
• Gratitude Questionnaire Six-Item Form (GQ-6) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Measures recent thinking about the various dimensions of social support.
• Measure of Current Status (MOCS) Part A [ Time Frame: 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 [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  A brief measure for assessing generalized anxiety disorder

Information By: Massachusetts General Hospital

Dates:
Date Received: February 25, 2015
Date Started: January 2015
Date Completion: December 2018
Last Updated: April 2, 2017
Last Verified: April 2017