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WithdrawnNCT02067234Updated May 19, 2015

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

An interventional study of Routine Care/Education and Psychoeducation/Coping Prevention in Atopic Dermatitis, sponsored by Seton Healthcare Family. Withdrawn at 1 site in United States. Open to participants aged 2 Months to 12 Years. Per ClinicalTrials.gov, last updated 2015-05-19.

Sponsored by Seton Healthcare Family · Not applicable, Interventional, and Prevention

Why this study was withdrawn
PI left institution; project closed.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
2 Months to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

Browse Dermatitis, Atopic studies →

Lead sponsor

Seton Healthcare Family is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patient does not agree to participate
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Routine Care/Education

    Patient will be assessed by MD and provided education by nurse

    Other: Routine Care/Education

  • 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

Interventions

  • OtherRoutine 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.

  • BehavioralPsychoeducation/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.

06

What researchers measure

Primary outcomes

  1. SCORAD

    Time frame: Change from initial visit to 2 week visit; Change from initial visit to 2 month follow-up appointments

Secondary outcomes

  1. Parenting Stress Index, Short Form

    Time frame: 2 month visit

  2. Children's Dermatology Life Quality Index (CDLQI)

    Time frame: 2 week visit; 2 month visit

  3. Infant's Dermatitis Quality of Life Index

    Time frame: 2 week visit; 2 month visit

  4. PO-SCORAD

    Time frame: 2 week visit; 2 month visit

07

Study locations

1 site
  • 'Specially for Children, Dell Children's Medical Center
    Austin, Texas 78723, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02067234
Lead sponsor
Seton Healthcare Family
Responsible party
Sponsor
First posted
Feb 20, 2014
Start date
Jan 2015
Primary completion
Apr 2015
Completion
Apr 2015
Last update
May 19, 2015

Study contacts

Catherine L Funk, Ph.D.
principal investigator · 'Specially for Children
Moise Levy, MD
principal investigator · 'Specially for Children

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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