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Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562339
Recruitment Status : Withdrawn (Due to the departure of study staff and lack of interest by potential subjects and the sponsor, the investigators decided to end the study.)
First Posted : September 29, 2015
Last Update Posted : June 28, 2016
Sponsor:
Collaborator:
Foundation For Faces of Children
Information provided by (Responsible Party):
John W. Denninger, MD, PhD, 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).

Condition or disease Intervention/treatment Phase
Craniofacial Abnormalities Behavioral: SMART-3RP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examining the Psychosocial Effects of Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers
Study Start Date : May 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: SMART-3RP for Parents or Caregivers
Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.
Behavioral: SMART-3RP
8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.

Experimental: SMART-3RP for Adolescent Patients
Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.
Behavioral: SMART-3RP
8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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.


Other Outcome Measures:
  1. Age, Gender, Race, Ethnicity, Type of Craniofacial Condition, and Education Status of patients with craniofacial conditions and their caregivers [ Time Frame: Baseline (week 0) ]
    This questionnaire asks patients/caregivers to report their age, gender, race, ethnicity, type of craniofacial condition, and highest level of education.

  2. Expectancy Questionnaire [ Time Frame: Baseline (week 0) ]
    Measures how much the participant believes the intervention will work

  3. Intent to Attend Questionnaire [ Time Frame: 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.

  4. Participant Feedback - Program Satisfaction Questionnaire [ Time Frame: Post-intervention (week 8) ]
    Measures how satisfied the participant is with the intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562339


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02141
Sponsors and Collaborators
Massachusetts General Hospital
Foundation For Faces of Children
Investigators
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Principal Investigator: John W. Denninger, MD, PhD Massachusetts General Hospital
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Responsible Party: John W. Denninger, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02562339    
Other Study ID Numbers: 2015P000956
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Craniofacial Abnormalities
Congenital Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases