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Due to the departure of study staff and lack of interest by potential subjects and the sponsor, the investigators decided to end the study.
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| Name | Class |
|---|---|
| Foundation For Faces of Children | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMART-3RP for Parents or Caregivers | Experimental | Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills. |
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| SMART-3RP for Adolescent Patients | Experimental | Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMART-3RP | Behavioral | 8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga. |
| 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) |
| The 14-Item Resiliency Scale (RS-14) | The RS-14 measures stress coping ability in the face of adversity. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with Life (SWL) | 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. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Measure | Description | Time Frame |
|---|---|---|
| Age, Gender, Race, Ethnicity, Type of Craniofacial Condition, and Education Status of patients with craniofacial conditions and their caregivers | This questionnaire asks patients/caregivers to report their age, gender, race, ethnicity, type of craniofacial condition, and highest level of education. | Baseline (week 0) |
Inclusion Criteria for Adolescent Patients:
Inclusion Criteria for Parents or Other Caregivers:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John W. Denninger, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02141 | United States |
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| ID | Term |
|---|---|
| D019465 | Craniofacial Abnormalities |
| ID | Term |
|---|---|
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Perceived Stress Scale (PSS-10) |
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. |
| Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Measure of Current Status (MOCS-A) | 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. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Patient Health Questionnaire (PHQ) - caregivers only | The PHQ measures symptoms of depression and functional impairment. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Patient Health Questionnaire for Adolescents (PHQ-A) - patients only | Symptoms of depression and functional impairment | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Generalized Anxiety Disorder 7-item (GAD-7) | A brief measure for assessing generalized anxiety disorder | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Cognitive and Affective Mindfulness Scale (CAMS) - caregivers only | The CAMS measures the degree to which individuals experience their thoughts and feelings. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Child and Adolescent Mindfulness Measure (CAMM) - patients only | Assesses mindfulness in children and adolescents | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Interpersonal Reactivity Index (IRI) | The IRI assesses the cognitive and affective dimensions of empathy. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Distress Analogue Scales | The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| The Gratitude Questionnaire (GQ-6) | 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. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Life Orientation Test (LOT) Optimism Scale | The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Medical Outcomes Study (MOS) Social Support Survey | The MOS Social Support Survey measures various dimensions of social support. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Rosenberg Self Esteem Scale (RES) | Assesses levels of self esteem | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| The Body Image Quality of Life Inventory (BIQLI) - patients only | Measures patients' perception of their own body image and how it relates to quality of life. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Expectancy Questionnaire |
Measures how much the participant believes the intervention will work |
| Baseline (week 0) |
| Intent to Attend Questionnaire | On a scale from 1 ["Not likely" or "Not motivated"] to 3 ["Very likely" or "Very motivated"], participants are asked how likely and how motivated they are to attend the next session. | Baseline (week 0) |
| Participant Feedback - Program Satisfaction Questionnaire | Measures how satisfied the participant is with the intervention | Post-intervention (week 8) |