Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers
- Conditions
- Craniofacial Abnormalities
- Interventions
- Behavioral: SMART-3RP
- Registration Number
- NCT02562339
- Lead Sponsor
- Massachusetts General Hospital
- 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 Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
- Unable to benefit from the program due to cognitive, psychiatric or other reasons based on the opinion of the group leader
- Unable or unwilling to sign the informed consent documents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SMART-3RP for Adolescent Patients SMART-3RP Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills. SMART-3RP for Parents or Caregivers SMART-3RP Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.
- Primary Outcome Measures
Name Time Method The 14-Item Resiliency Scale (RS-14) 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.
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.
- Secondary Outcome Measures
Name Time Method Satisfaction with Life (SWL) 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.
Patient Health Questionnaire (PHQ) - caregivers only Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) The PHQ measures symptoms of depression and functional impairment.
Child and Adolescent Mindfulness Measure (CAMM) - patients only Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) Assesses mindfulness in children and adolescents
The Gratitude Questionnaire (GQ-6) 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.
Measure of Current Status (MOCS-A) 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 for Adolescents (PHQ-A) - patients only 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) 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 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.
Interpersonal Reactivity Index (IRI) Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) The IRI assesses the cognitive and affective dimensions of empathy.
Perceived Stress Scale (PSS-10) 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.
Distress Analogue Scales 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.
Medical Outcomes Study (MOS) Social Support Survey 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.
Life Orientation Test (LOT) Optimism Scale 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.
Rosenberg Self Esteem Scale (RES) 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 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.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States