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Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers

Primary Purpose

Craniofacial Abnormalities

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMART-3RP
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craniofacial Abnormalities

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SMART-3RP for Parents or Caregivers

SMART-3RP for Adolescent Patients

Arm Description

Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.

Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.

Outcomes

Primary Outcome Measures

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.
The 14-Item Resiliency Scale (RS-14)
The RS-14 measures stress coping ability in the face of adversity.

Secondary Outcome Measures

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.
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.
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.
Patient Health Questionnaire (PHQ) - caregivers only
The PHQ measures symptoms of depression and functional impairment.
Patient Health Questionnaire for Adolescents (PHQ-A) - patients only
Symptoms of depression and functional impairment
Generalized Anxiety Disorder 7-item (GAD-7)
A brief measure for assessing generalized anxiety disorder
Cognitive and Affective Mindfulness Scale (CAMS) - caregivers only
The CAMS measures the degree to which individuals experience their thoughts and feelings.
Child and Adolescent Mindfulness Measure (CAMM) - patients only
Assesses mindfulness in children and adolescents
Interpersonal Reactivity Index (IRI)
The IRI assesses the cognitive and affective dimensions of empathy.
Distress Analogue Scales
The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort.
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.
Life Orientation Test (LOT) Optimism Scale
The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
Medical Outcomes Study (MOS) Social Support Survey
The MOS Social Support Survey measures various dimensions of social support.
Rosenberg Self Esteem Scale (RES)
Assesses levels of self esteem
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.

Full Information

First Posted
September 21, 2015
Last Updated
June 24, 2016
Sponsor
Massachusetts General Hospital
Collaborators
Foundation For Faces of Children
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1. Study Identification

Unique Protocol Identification Number
NCT02562339
Brief Title
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Due to the departure of study staff and lack of interest by potential subjects and the sponsor, the investigators decided to end the study.
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Foundation For Faces of Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniofacial Abnormalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMART-3RP for Parents or Caregivers
Arm Type
Experimental
Arm Description
Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.
Arm Title
SMART-3RP for Adolescent Patients
Arm Type
Experimental
Arm Description
Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.
Intervention Type
Behavioral
Intervention Name(s)
SMART-3RP
Intervention Description
8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.
Primary Outcome Measure Information:
Title
Quality of Life (WHOQOL-BREF)
Description
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.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
The 14-Item Resiliency Scale (RS-14)
Description
The RS-14 measures stress coping ability in the face of adversity.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary Outcome Measure Information:
Title
Satisfaction with Life (SWL)
Description
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.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Perceived Stress Scale (PSS-10)
Description
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.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Measure of Current Status (MOCS-A)
Description
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.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Patient Health Questionnaire (PHQ) - caregivers only
Description
The PHQ measures symptoms of depression and functional impairment.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Patient Health Questionnaire for Adolescents (PHQ-A) - patients only
Description
Symptoms of depression and functional impairment
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Generalized Anxiety Disorder 7-item (GAD-7)
Description
A brief measure for assessing generalized anxiety disorder
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Cognitive and Affective Mindfulness Scale (CAMS) - caregivers only
Description
The CAMS measures the degree to which individuals experience their thoughts and feelings.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Child and Adolescent Mindfulness Measure (CAMM) - patients only
Description
Assesses mindfulness in children and adolescents
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Interpersonal Reactivity Index (IRI)
Description
The IRI assesses the cognitive and affective dimensions of empathy.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Distress Analogue Scales
Description
The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
The Gratitude Questionnaire (GQ-6)
Description
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.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Life Orientation Test (LOT) Optimism Scale
Description
The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Medical Outcomes Study (MOS) Social Support Survey
Description
The MOS Social Support Survey measures various dimensions of social support.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Rosenberg Self Esteem Scale (RES)
Description
Assesses levels of self esteem
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
The Body Image Quality of Life Inventory (BIQLI) - patients only
Description
Measures patients' perception of their own body image and how it relates to quality of life.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Other Pre-specified Outcome Measures:
Title
Age, Gender, Race, Ethnicity, Type of Craniofacial Condition, and Education Status of patients with craniofacial conditions and their caregivers
Description
This questionnaire asks patients/caregivers to report their age, gender, race, ethnicity, type of craniofacial condition, and highest level of education.
Time Frame
Baseline (week 0)
Title
Expectancy Questionnaire
Description
Measures how much the participant believes the intervention will work
Time Frame
Baseline (week 0)
Title
Intent to Attend Questionnaire
Description
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.
Time Frame
Baseline (week 0)
Title
Participant Feedback - Program Satisfaction Questionnaire
Description
Measures how satisfied the participant is with the intervention
Time Frame
Post-intervention (week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Adolescent Patients: Adolescents aged 14 to 22 English fluency and literacy Diagnosis of a craniofacial condition by self report Inclusion Criteria for Parents or Other Caregivers: Must be 18 years of age and older English fluency and literacy Parent or caregiver of a child or young adult with a craniofacial condition Exclusion Criteria: Unable to benefit from the program due to cognitive, psychiatric or other reasons based on the opinion of the group leader Unable or unwilling to sign the informed consent documents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W. Denninger, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02141
Country
United States

12. IPD Sharing Statement

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Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers

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