Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers

Craniofacial Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02562339
• Other study ID #: 2015P000956
• Status: Withdrawn
• Phase: N/A
• First received: September 21, 2015
• Last updated: June 24, 2016
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Craniofacial Abnormalities

Intervention

Behavioral:
• SMART-3RP
8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Foundation For Faces of Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Other	Expectancy Questionnaire	Measures how much the participant believes the intervention will work	Baseline (week 0)	No
Other	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)	No
Other	Participant Feedback - Program Satisfaction Questionnaire	Measures how satisfied the participant is with the intervention	Post-intervention (week 8)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Rosenberg Self Esteem Scale (RES)	Assesses levels of self esteem	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)	No
Secondary	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)	No