NCT02562339

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

September 21, 2015

Last Update Submit

June 24, 2016

Conditions

Craniofacial Abnormalities

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (15)

  • Satisfaction with Life (SWL)

    Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

  • Perceived Stress Scale (PSS-10)

    Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

  • Measure of Current Status (MOCS-A)

    Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

  • Patient Health Questionnaire (PHQ) - caregivers only

    Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

  • Patient Health Questionnaire for Adolescents (PHQ-A) - patients only

    Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

  • +10 more secondary outcomes

Other Outcomes (4)

  • Age, Gender, Race, Ethnicity, Type of Craniofacial Condition, and Education Status of patients with craniofacial conditions and their caregivers

    Baseline (week 0)

  • Expectancy Questionnaire

    Baseline (week 0)

  • Intent to Attend Questionnaire

    Baseline (week 0)

  • +1 more other outcomes

Study Arms (2)

SMART-3RP for Parents or Caregivers

EXPERIMENTAL

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

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.

Behavioral: SMART-3RP

Interventions

SMART-3RPBEHAVIORAL

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

SMART-3RP for Adolescent PatientsSMART-3RP for Parents or Caregivers

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02141, United States

Location

MeSH Terms

Conditions

Craniofacial Abnormalities

Condition Hierarchy (Ancestors)

Musculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • John W. Denninger, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 29, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations

US(1)