A Psychoeducational Prevention for the Treatment of Atopic Dermatitis in Youth and Their Families

May 18, 2015 updated by: Seton Healthcare Family

A Multi-Disciplinary Psychoeducational Prevention for the Treatment of Atopic Dermatitis in Youth and Their Families: A Pilot Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78723
        • 'Specially for Children, Dell Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Routine Care/Education
Patient will be assessed by MD and provided education by nurse
Other: Routine Care/Education
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.
Experimental: Psychoeducation/Coping Prevention
Patient will be assessed by MD and will meet with psychologist to obtain psychoeducation about coping, behavioral strategies, and sleep hygiene
Behavioral: Psychoeducation/Coping Prevention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SCORAD
Time Frame: Change from initial visit to 2 week visit; Change from initial visit to 2 month follow-up appointments
Change from initial visit to 2 week visit; Change from initial visit to 2 month follow-up appointments

Secondary Outcome Measures

Outcome Measure
Time Frame
Parenting Stress Index, Short Form
Time Frame: 2 month visit
2 month visit
Children's Dermatology Life Quality Index (CDLQI)
Time Frame: 2 week visit; 2 month visit
2 week visit; 2 month visit
Infant's Dermatitis Quality of Life Index
Time Frame: 2 week visit; 2 month visit
2 week visit; 2 month visit
PO-SCORAD
Time Frame: 2 week visit; 2 month visit
2 week visit; 2 month visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seton Healthcare Family

Investigators

  • Principal Investigator: Catherine L Funk, Ph.D., 'Specially for Children
  • Principal Investigator: Moise Levy, MD, 'Specially for Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 3, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-14-027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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