Clinical Trial: Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Examining the Psychosocial Effects of Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers

Brief Summary: This is a prospective study that will examine psychosocial improvements among CF adolescents and caregivers going through the Stress Management and Resiliency Training - Relaxation Response Resiliency Program (SMART-3RP).

Detailed Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome:

• 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.
• The 14-Item Resiliency Scale (RS-14) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  The RS-14 measures stress coping ability in the face of adversity.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Satisfaction with Life (SWL) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  The Satisfaction with Life (SWL) scale is a reliable and valid 5-item self-report measure of global life satisfaction. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
• Perceived Stress Scale (PSS-10) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  The PSS is a widely used psychological instrument for the measurement of the perception of stress. This 10-itam scale is designed to measure the degree to which situations in one's life are appraised, or considered stressful. The scores range from 0-40, with a higher score indicating higher perceived stress. Items were designed to detect how unpredictable, uncontrollable and overloaded respondents find their lives.
• Measure of Current Status (MOCS-A) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  The MOCS-A is a 13-item measure assessing participants' current self-perceived status on several skills such as: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
• Patient Health Questionnaire (PHQ) - caregivers only [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  The PHQ measures symptoms of depression and functional impairment.
• Patient Health Questionnaire for Adolescents (PHQ-A) - patients only [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Symptoms of depression and functional impairment
• Generalized Anxiety Disorder 7-item (GAD-7) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  A brief measure for assessing generalized anxiety disorder
• Cognitive and Affective Mindfulness Scale (CAMS) - caregivers only [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  The CAMS measures the degree to which individuals experience their thoughts and feelings.
• Child and Adolescent Mindfulness Measure (CAMM) - patients only [ 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) ]
  The IRI assesses the cognitive and affective dimensions of empathy.
• Distress Analogue Scales [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort.
• The Gratitude Questionnaire (GQ-6) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  The GQ-6 revised is a 6-item measure that assesses individual differences in the proneness to experience gratitude in daily life. Scores range from 6-42, with a higher score indicating a greater sense of gratitude.
• Life Orientation Test (LOT) Optimism Scale [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
• Medical Outcomes Study (MOS) Social Support Survey [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  The MOS Social Support Survey measures various dimensions of social support.
• Rosenberg Self Esteem Scale (RES) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Assesses levels of self esteem
• The Body Image Quality of Life Inventory (BIQLI) - patients only [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
  Measures patients' perception of their own body image and how it relates to quality of life.

Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: September 21, 2015
Date Started: May 2015
Date Completion:
Last Updated: June 24, 2016
Last Verified: June 2016