Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers

NCT ID: NCT02562339

Last Updated: 2016-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Craniofacial Abnormalities

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SMART-3RP for Parents or Caregivers

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

Group Type EXPERIMENTAL

SMART-3RP

Intervention Type BEHAVIORAL

8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.

SMART-3RP for Adolescent Patients

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

Group Type EXPERIMENTAL

SMART-3RP

Intervention Type BEHAVIORAL

8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.

Interventions

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SMART-3RP

8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Adolescents aged 14 to 22
2. English fluency and literacy
3. Diagnosis of a craniofacial condition by self report


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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Foundation For Faces of Children

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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John W. Denninger, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John W. Denninger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2015P000956

Identifier Type: -

Identifier Source: org_study_id

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