A Psychoeducational Prevention for the Treatment of Atopic Dermatitis in Youth and Their Families
Primary Purpose
Atopic Dermatitis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Routine Care/Education
Psychoeducation/Coping Prevention
Sponsored by
About this trial
This is an interventional prevention trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Patient age between 2 months and 12 years
- Patient and family speak English or Spanish
- Patient has diagnosis of Atopic Dermatitis
Exclusion Criteria:
- Patient does not agree to participate
Sites / Locations
- 'Specially for Children, Dell Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Routine Care/Education
Psychoeducation/Coping Prevention
Arm Description
Patient will be assessed by MD and provided education by nurse
Patient will be assessed by MD and will meet with psychologist to obtain psychoeducation about coping, behavioral strategies, and sleep hygiene
Outcomes
Primary Outcome Measures
SCORAD
Secondary Outcome Measures
Parenting Stress Index, Short Form
Children's Dermatology Life Quality Index (CDLQI)
Infant's Dermatitis Quality of Life Index
PO-SCORAD
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02067234
Brief Title
A Psychoeducational Prevention for the Treatment of Atopic Dermatitis in Youth and Their Families
Official Title
A Multi-Disciplinary Psychoeducational Prevention for the Treatment of Atopic Dermatitis in Youth and Their Families: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution; project closed.
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seton Healthcare Family
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of the current investigation is to determine whether the inclusion of a parent/patient psychoeducational session in initial dermatology appointments with new pediatric atopic dermatitis patients affects (a) extent of medical follow-up, (b) patient's quality of life, and (c) parenting stress in comparison to treatment as usual for initial pediatric dermatology appointments for new pediatric patients with atopic dermatitis.
Detailed Description
Youth will be selected to participate based on request for initial intake appointments regarding atopic dermatitis or eczema at the Pediatric Dermatology office at 'Specially for Children. Once consented into the study, youth and parents will be randomized into either the routine care group (medical visit with nurse and medical provider) or the prevention group (medical visit with nurse and medical provider, psychoeducation session with psychologist). Randomization will occur through a pre-determined randomized list. Next, youth and parents will complete questionnaires (listed above, see Appendix X) in the clinic setting prior to their appointment with the medical provider. At that time, the intervention will commence. All patient interaction between the patient, patient's family, and the study investigators will be conducted at the Pediatric Dermatology Clinic at 'Specially for Children or Dell Children's Medical Center. Demographic and clinical data will be collected and de-identified from the patients' medical records. Each condition's details are listed below along with a flowchart describing the investigation process.
Routine Care Group Initial Evaluation: The family will be requested to fill out all measures for an initial assessment (Parenting Stress Index, Children's Dermatology Quality of Life Index/Infant Dermatitis Quality of Life Index, and the Patient Oriented SCORAD). As part of the medical initial evaluation, the medical provider will complete the SCORAD as part of his/her medical evaluation. Further, nursing staff will spend time educating the patient and family about therapy involved in medically treating atopic dermatitis. The total time estimated to fill out measures and complete initial intake evaluation is about 40 minutes.
First Follow-up Appointment: Patient will be seen two weeks later for a follow-up visit where the family will complete the Patient Oriented SCORAD and the medical provider will complete the SCORAD as part of the medical evaluation and recommendations that make up the follow up appointment. Nursing staff will again spend time educating the patient and family about therapy involved in medically treating atopic dermatitis to determine that family has sufficient education regarding care. Additional data collected at this time will be the number of days since initial visit (collected through medical record).
Two month Follow-up Appointment: Finally, the family will be requested to schedule a 2 month follow up to fill out all measures again and have a follow up medical visit. Additional data collected at this time from the medical chart will be number of times the family has contacted the dermatology office since the initial evaluation appointment. The family will also be asked to complete a satisfaction survey about their experience at this time.
Prevention Group Initial Evaluation: The family will be requested to fill out all measures for an initial assessment (Parenting Stress Index, Children's Dermatology Quality of Life Index/Infant Dermatitis Quality of Life Index, and the Patient Oriented SCORAD). During the medical part of the visit, the medical provider will complete the SCORAD as part of his/her medical evaluation. Nursing staff will briefly educate the patient and family about therapy involved in medically treating atopic dermatitis. Then, the family will meet with the psychologist for about 30 minutes following medical visit to get psychoeducation and introduction to coping, sleep, and behavior strategies. The total time estimated to fill out measures and complete initial intake evaluation is about 50 minutes.
First Follow-up Appointment: Patient will be seen two weeks later for a follow-up visit where the family will complete the Patient Oriented SCORAD and the medical provider will complete the SCORAD as part of the medical evaluation and recommendations that make up the follow up appointment. Additional data collected at this time will be the number of days since initial visit (collected through medical record). The family will meet with the psychologist for another 30 minutes a review or elaboration of coping, sleep, and behavior strategies. Additional data collected at this time will be the number of days since initial visit (collected through medical record).
Two month Follow-up Appointment: Finally, the family will be requested to schedule a 2 month follow up to fill out all measures post prevention and have a follow up medical visit. Additional data collected at this time from the medical chart will be number of times the family has contacted the dermatology office since the initial evaluation appointment. The family will also be asked to complete a satisfaction survey about their experience at this time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine Care/Education
Arm Type
Active Comparator
Arm Description
Patient will be assessed by MD and provided education by nurse
Arm Title
Psychoeducation/Coping Prevention
Arm Type
Experimental
Arm Description
Patient will be assessed by MD and will meet with psychologist to obtain psychoeducation about coping, behavioral strategies, and sleep hygiene
Intervention Type
Other
Intervention Name(s)
Routine Care/Education
Intervention Description
Nursing staff will spend time educating the patient and family about therapy involved in medically treating atopic dermatitis. This might include different topical therapy to use as well as how often to apply and when to apply.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation/Coping Prevention
Intervention Description
In addition to routine care, the psychologist will meet with family to review psychoeducation about the mind-body connection as well as introduce and review different strategies regarding coping with stress, sleep strategies, and behavior strategies.
Primary Outcome Measure Information:
Title
SCORAD
Time Frame
Change from initial visit to 2 week visit; Change from initial visit to 2 month follow-up appointments
Secondary Outcome Measure Information:
Title
Parenting Stress Index, Short Form
Time Frame
2 month visit
Title
Children's Dermatology Life Quality Index (CDLQI)
Time Frame
2 week visit; 2 month visit
Title
Infant's Dermatitis Quality of Life Index
Time Frame
2 week visit; 2 month visit
Title
PO-SCORAD
Time Frame
2 week visit; 2 month visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient age between 2 months and 12 years
Patient and family speak English or Spanish
Patient has diagnosis of Atopic Dermatitis
Exclusion Criteria:
Patient does not agree to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine L Funk, Ph.D.
Organizational Affiliation
'Specially for Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moise Levy, MD
Organizational Affiliation
'Specially for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
'Specially for Children, Dell Children's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
12. IPD Sharing Statement
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A Psychoeducational Prevention for the Treatment of Atopic Dermatitis in Youth and Their Families
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