Study Stopped
PI left institution; project closed.
A Psychoeducational Prevention for the Treatment of Atopic Dermatitis in Youth and Their Families
A Multi-Disciplinary Psychoeducational Prevention for the Treatment of Atopic Dermatitis in Youth and Their Families: A Pilot Study
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2014
CompletedFirst Posted
Study publicly available on registry
February 20, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 19, 2015
May 1, 2015
3 months
January 3, 2014
May 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
SCORAD
Change from initial visit to 2 week visit; Change from initial visit to 2 month follow-up appointments
Secondary Outcomes (4)
Parenting Stress Index, Short Form
2 month visit
Children's Dermatology Life Quality Index (CDLQI)
2 week visit; 2 month visit
Infant's Dermatitis Quality of Life Index
2 week visit; 2 month visit
PO-SCORAD
2 week visit; 2 month visit
Study Arms (2)
Routine Care/Education
ACTIVE COMPARATORPatient will be assessed by MD and provided education by nurse
Psychoeducation/Coping Prevention
EXPERIMENTALPatient will be assessed by MD and will meet with psychologist to obtain psychoeducation about coping, behavioral strategies, and sleep hygiene
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patient age between 2 months and 12 years
- Patient and family speak English or Spanish
- Patient has diagnosis of Atopic Dermatitis
You may not qualify if:
- Patient does not agree to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
'Specially for Children, Dell Children's Medical Center
Austin, Texas, 78723, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine L Funk, Ph.D.
'Specially for Children
- PRINCIPAL INVESTIGATOR
Moise Levy, MD
'Specially for Children
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2014
First Posted
February 20, 2014
Study Start
January 1, 2015
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 19, 2015
Record last verified: 2015-05