Craniofacial Abnormalities
Conditions
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).
Interventions
BEHAVIORALSMART-3RP
8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.
Sponsors
Foundation For Faces of Children
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Adolescent Patients: 1. Adolescents aged 14 to 22 2. English fluency and literacy 3. Diagnosis of a craniofacial condition by self report Inclusion Criteria for Parents or Other Caregivers: 1. Must be 18 years of age and older 2. English fluency and literacy 3. Parent or caregiver of a child or young adult with a craniofacial condition
Exclusion criteria
1. Unable to benefit from the program due to cognitive, psychiatric or other reasons based on the opinion of the group leader 2. Unable or unwilling to sign the informed consent documents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant Feedback - Program Satisfaction Questionnaire | Post-intervention (week 8) | Measures how satisfied the participant is with the intervention |
| Age, Gender, Race, Ethnicity, Type of Craniofacial Condition, and Education Status of patients with craniofacial conditions and their caregivers | Baseline (week 0) | This questionnaire asks patients/caregivers to report their age, gender, race, ethnicity, type of craniofacial condition, and highest level of education. |
| Intent to Attend Questionnaire | Baseline (week 0) | 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. |
| Expectancy Questionnaire | Baseline (week 0) | Measures how much the participant believes the intervention will work |
Countries
United States
Outcome results
None listed