Craniofacial AbnormalitiesNCT02562339
Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers
A study testing SMART-3RP in people with Craniofacial Abnormalities, run by Massachusetts General Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Craniofacial Abnormalities
- What is being tested?
- SMART-3RP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adolescents aged 14 to 22
- English fluency and literacy
- Diagnosis of a craniofacial condition by self report
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02141
About this study
Official title: 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).
- Conditions
- Craniofacial Abnormalities
- Being tested
- SMART-3RP
- Medical subject headings
- Craniofacial Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART-3RPBehavioural
8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.
| Study group | Role | What they receive |
|---|---|---|
| SMART-3RP for Parents or Caregivers | Experimental | Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills. Receives: Behavioral: SMART-3RP |
| SMART-3RP for Adolescent Patients | Experimental | Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills. Receives: Behavioral: SMART-3RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Rosenberg Self Esteem Scale (RES)
Assesses levels of self esteem
Measured: 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.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation For Faces of Children
- Responsible party
- Principal investigator, John W. Denninger, MD, PhD, Massachusetts General Hospital
- Investigators
- John W. Denninger, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562339
- Sponsor's protocol ID
- 2015P000956
- Status last verified
- Jun 2016
- First submitted
- 21 Sep 2015
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Psychosocial Effects of Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers
- ClinicalTrials.gov ID
- NCT02562339
- Acronym / sponsor ID
- 2015P000956
- Conditions
- Craniofacial Abnormalities
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Foundation For Faces of Children
- Study start
- May 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART-3RP for Parents or Caregivers | Experimental | Behavioral: SMART-3RPParticipants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills. |
| SMART-3RP for Adolescent Patients | Experimental | Behavioral: SMART-3RPParticipants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Adolescents aged 14 to 22
- English fluency and literacy
- Diagnosis of a craniofacial condition by self report
- Must be 18 years of age and older
- English fluency and literacy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART-3RP8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga. | Behavioural | SMART-3RP for Adolescent Patients, SMART-3RP for Parents or Caregivers |
Primary outcome
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.
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.
15 secondary outcomes
Satisfaction with Life (SWL)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Perceived Stress Scale (PSS-10)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Measure of Current Status (MOCS-A)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Patient Health Questionnaire (PHQ) - caregivers only
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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)
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Cognitive and Affective Mindfulness Scale (CAMS) - caregivers only
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Child and Adolescent Mindfulness Measure (CAMM) - patients only
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Interpersonal Reactivity Index (IRI)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Distress Analogue Scales
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The Gratitude Questionnaire (GQ-6)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Life Orientation Test (LOT) Optimism Scale
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Medical Outcomes Study (MOS) Social Support Survey
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Rosenberg Self Esteem Scale (RES)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W. Denninger, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART-3RP in people with Craniofacial Abnormalities, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (WHOQOL-BREF) (time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.