Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype

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.

Study Overview

• Status: Completed
• Conditions: Neurofibromatoses
• Intervention / Treatment: Behavioral: Stress Management Group 1; Behavioral: Stress Management Group 2

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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)
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)
Satisfaction with life adolescent	measures global satisfaction with life	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expectancy Questionnaire	Measures how much the participant believes the intervention will work	Baseline (week 0)
Participant Feedback - Program Satisfaction Questionnaire	Measures how satisfied the participant is with the intervention	Post-intervention (week 8)
Intent to Attend	Measures how likely and how motivated the participants is to attend the next session.	Baseline (week 0)
Demographics	Basic demographics	Baseline (week 0)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: The Children's Tumor Foundation
• Investigators: Principal Investigator: Ana-Maira Vranceanu, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 25, 2015
• First Submitted That Met QC Criteria: March 6, 2015
• First Posted (Estimate): March 12, 2015

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Nervous System Neoplasms; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Nerve Sheath Neoplasms; Neurocutaneous Syndromes; Peripheral Nervous System Neoplasms; Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
• Other Study ID Numbers: 2014P000702