Clinical trial NCT02562339: Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers
Official title: Examining the Psychosocial Effects of Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Craniofacial Abnormalities
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Foundation For Faces of Children
First posted: 2015-09-29
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Quality of Life (WHOQOL-BREF)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: The 14-Item Resiliency Scale (RS-14)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary outcomes:
measure: Satisfaction with Life (SWL)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Perceived Stress Scale (PSS-10)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Measure of Current Status (MOCS-A)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Patient Health Questionnaire (PHQ) - caregivers only
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Patient Health Questionnaire for Adolescents (PHQ-A) - patients only
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Cognitive and Affective Mindfulness Scale (CAMS) - caregivers only
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Child and Adolescent Mindfulness Measure (CAMM) - patients only
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Interpersonal Reactivity Index (IRI)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Distress Analogue Scales
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: The Gratitude Questionnaire (GQ-6)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Life Orientation Test (LOT) Optimism Scale
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Medical Outcomes Study (MOS) Social Support Survey
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Rosenberg Self Esteem Scale (RES)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: The Body Image Quality of Life Inventory (BIQLI) - patients only
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Other outcomes:
measure: Age, Gender, Race, Ethnicity, Type of Craniofacial Condition, and Education Status of patients with craniofacial conditions and their caregivers
timeFrame: Baseline (week 0)
measure: Expectancy Questionnaire
timeFrame: Baseline (week 0)
measure: Intent to Attend Questionnaire
timeFrame: Baseline (week 0)
measure: Participant Feedback - Program Satisfaction Questionnaire
timeFrame: Post-intervention (week 8)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: John W. Denninger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: