Behavioral Self-Help Intervention for Pediatric Atopic Dermatitis and Eczema Patients

Background Psychological interventions for atopic dermatitis (AD) in children are not
well-studied, despite the potential benefits, which may include: decreased need for
medications and improved long-term control of both dermatologic symptoms as well as other
secondary symptoms that may impact quality of life, such as anxiety, insomnia, and
psychosocial distress. Chida and colleagues (2007) conducted a meta-analysis of psychological
interventions for AD. Of the eight studies that were included in the meta-analysis, only four
studies examined pediatric patients. A wide-range of psychological interventions were
evaluated, including cognitive-behavioral therapy, stress management programs, aromatherapy
massage, psychodynamic therapy, and structured educational programs focusing on a wide range
of medical and psychological topics (e.g., nutrition, relaxation). Seven of the eight studies
showed some positive effects on measures of eczema severity, scratching/itching, use of
topical steroids, and anxiety.

More recently, Ersser and colleagues (2014) evaluated the literature on psychological and
educational interventions for AD focusing on studies conducted among children. Ten randomized
controlled trials were reviewed, including 9 educational interventions and one study that
evaluated a psychological intervention.Particular promise in terms of modest improvement in
disease severity and quality of life was noted in a large study (N=992) that utilized a
multidisciplinary group education intervention in an inpatient setting. However, the authors
of the review concluded that there is a lack of research on this topic. Accordingly,
additional studies evaluating psychological and educational interventions are needed.
Previous studies have evaluated time- and resource-intensive interventions that may not be
practical outside of a randomized controlled trial or a large academic research setting.
Nevertheless, adjunctive psychological interventions are promising for reducing symptoms
associated with severe dermatologic issues. To address this gap, the current study will
evaluate the utility and acceptability of a brief self-help behavioral intervention in a
pilot study, which emphasizes the effectiveness of the study design. A brief self-help
intervention that utilizes well-supported cognitive and behavioral psychological strategies
will be distributed to interested patients and families to augment the standard skin-directed
treatments for eczema or AD. The self-help intervention will be distributed to and discussed
with a family in less than five minutes in an outpatient clinic setting by clinical staff
with no special training in psychology. The target population is children with AD aged 4-12
years with prominent excoriations and their guardians. At the standard 1-4 month follow-up
visit, feasibility and acceptability of the self-help intervention will be assessed. Brief
evaluations of medical and behavioral symptoms will be conducted at the initial visit and the
follow-up.

Purpose The purpose of the current study is to pilot a brief self-help behavioral
intervention that will be implemented in conjunction with treatment as usual in children with
AD or eczema between the ages of 4 and 12 years. The acceptability and effectiveness of the
intervention will be evaluated. The intervention aims to reduce the severity of AD or eczema
symptoms and improve the quality of life in children. It is hypothesized that the adjunctive
self-help behavioral treatment will reduce the severity of eczema and improve quality of life
for patients who receive the intervention compared to patients who only receive standard
dermatologic treatment. Additionally, itching intensity, scratching behaviors, and anxiety
symptoms will be included as outcome measures.

Specific Aims Aim 1: Pilot a brief self-help behavioral intervention to be delivered to
children with eczema or AD and their parents.

Aim 2: Evaluate feasibility and acceptability of a brief self-help behavioral intervention.

Aim 3: Evaluate effectiveness of the self-help intervention for reducing symptom severity and
improving quality of life.

Study Period This study will occur over a two year period from July 1, 2015 thru June 30,
2017. Interested patients will receive the treatment information at the first appointment and
then a follow up visit will be conducted 1-4 months later.

Study Methodology Study Design This will be a randomized, case-controlled, prospective trial
that compares treatment as usual to treatment as usual with the addition of the brief
self-help intervention. Half of the patients will receive the self-help intervention and the
other half will not receive the self-help intervention. A priori block randomization
procedures will be conducted in attempt to secure an equal distribution of participants in
each condition. The block randomization involves randomizing blocks of 6-8 participant
numbers, where half of the participants in the treatment as usual group and half of the
participants in the treatment group. Then, the order of the blocks are randomized. The
physician (Dr. Jacks) recruiting participants will be blind to the condition until after the
patient has consented to participate. All patients will receive the standard of care for
eczema or atopic dermatitis, which may include dry skin care with emollients, topical
steroids, topical calcineurin inhibitors, and oral antihistamines. All patients will undergo
initial evaluation and then a follow up evaluation at 1-4 months later.

Research Participants (N = 150) Children between the ages of 4 and 12 and their parents who
are presenting to the UMMC pediatric dermatology clinic will be invited to participate in the
study. It is anticipated that 75 parent-child dyads will enroll in the study procedures, for
a total of 75 children and 75 parents.

Inclusion criteria Inclusion criteria: (1) children presenting to the pediatric dermatology
clinic; (2) current or new diagnosis of eczema or AD; (3) between the ages of 4 and 12; and
(4) excoriation is reported by the patient or parent or noted by the clinical staff to be a
prominent issues within the past month.

Exclusion criteria Exclusion criteria: (1) inability to complete English-language
questionnaires; (2) patients requiring systemic immunosuppressives such as systemic
prednisone, methotrexate, azathioprine, mycophenolate mofetil, or cyclosporine; (3) Patients
with known comorbidities that cause immunodeficiency, such as HIV, treatment with
chemotherapy, or genetic syndromes; (4) Patients who are being treated by a mental health
provider (e.g., counselor, psychologist) or psychiatrist for issues specifically related to
excoriation.

Procedure. Recruitment will occur through the UMMC pediatric dermatology clinic. Clinical
staff will identify potential study participants through Epic database searches and chart
reviews of eczema and atopic dermatitis pediatric patients seen in the UMMC Dermatology
Clinic practice. The treating physician (Dr. Jacks) will approach potential participants
either by phone or in person at the clinic to inform them of the study and its procedures and
to see if they are interested in participating. If interested, screening criteria will be
reviewed with the patients and their parents. If the patient is eligible for the study, they
will be invited to participate in the study. Consent, parent permission, and child assent
will be obtained children and their parents.

At the initial visit, after the patient has received standard care or while in the
examination room waiting for standard care, the patients and their parents will complete
several brief self-report questionnaires that will take approximately 10 minutes to complete.
These questionnaires will assess socio-demographic information, symptom intensity, quality of
life, anxiety symptoms, and symptom severity. A priori randomization will determine whether
the participant receives the self-help intervention or not. For participants randomized to
receive the treatment, the self-help intervention will be briefly described by a member of
the clinical staff, and a brief pamphlet will be distributed to the parent or guardian at the
end of the visit. The pamphlet describes behavioral strategies for coping with and reducing
scratching behaviors. Participants randomly selected to not receive the treatment will not
receive the pamphlet at the end of the visit. A routine follow-up appointment will be
scheduled with all patients, which is typically scheduled 1-4 months after the initial visit.
This is a routine follow-up interval for children with active eczema or AD.

At the follow-up visit, verbal consent for the follow up assessment will be obtained from
participants. Patients and their parents who provide verbal consent will complete a second
set of brief self-report questionnaires in the waiting room or while in the examination room.
The questionnaires are expected to take approximately 10 minutes to complete. The
questionnaires will include measures assessing acceptability and feasibility of the self-help
intervention, quality of life, anxiety symptoms, and dermatology symptom severity (i.e.,
SCORAD). For patients who are unable to come in for the follow-up visit, typical clinical
procedures for following up with a missed appointment will be followed. Additional attempts
to contact the participant will be made by the research personnel to contact the parents by
telephone to either to complete the questionnaires over the telephone or to come in for the
brief follow up study visit. If participants chose to attend the study session, but not the
follow up dermatology appointment, then they would not receive the standard care visit, but
would only complete the study procedures and accordingly would not be billed. If the
participant expresses that they are not interested in participating in the follow up study
visit, study personnel will cease attempts at study contact and follow up.

Measures. Screener. A brief screener will be conducted with the patient and the parent to
verify eligibility in the study per the inclusion and exclusion criteria.

Assessment of Co-variates Socio-demographics Form. The parents/guardians of patients will be
asked questions related to their and their child's demographics, including age, race, marital
status, socioeconomic status, and medical history (including current medications).

Inclusion Criteria:

1. children presenting to the pediatric dermatology clinic;

2. current or new diagnosis of eczema or AD;

3. between the ages of 4 and 12;

4. excoriation is reported by the patient or parent or noted by the clinical staff to be
a prominent issues within the past month.

Exclusion Criteria:

1. inability to complete English-language questionnaires;

2. patients requiring systemic immunosuppressives such as systemic prednisone,
methotrexate, azathioprine, mycophenolate mofetil, or cyclosporine;

3. Patients with known comorbidities that cause immunodeficiency, such as HIV, treatment
with chemotherapy, or genetic syndromes;

4. Patients who are being treated by a mental health provider (e.g., counselor,
psychologist) or psychiatrist for issues specifically related to excoriation.