Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Craniofacial Abnormalities
• Intervention / Treatment: Behavioral: SMART-3RP

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02141
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Other Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Foundation For Faces of Children
• Investigators: Principal Investigator: John W. Denninger, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 21, 2015
• First Submitted That Met QC Criteria: September 25, 2015
• First Posted (Estimate): September 29, 2015

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 24, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Craniofacial Abnormalities
• Other Study ID Numbers: 2015P000956

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No