A Randomized Trial of Behavioral Modification Program for Mothers of Children with Atopic Dermatitis

UMIN ID: UMIN000000794

Registered date:08/08/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Children with Atopic Dermatitis
• Date of first enrollment: 2007/06/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Behavial Modification Program (One night hands-on hospital stay, self monitored skin-care according to skin-care table AND monthly feedback sessions by specialized nurse upto three months.)
Standard Therapy (Steroid ointment and General information)

Outcome(s)

• Primary Outcome: SCORAD at baseline, three and six month later
• Secondary Outcome: DFI (Family Impact of Childhood Eczema Questionnaire) QPCAD (Quality of Life in Primary Caregivers of children with Atopic Dermatitis) STAI (State Trait Anxiety Inventory) Ammount of steroid ointment prescribed after three and six months

Key inclusion & exclusion criteria

• Age minimum: 6months-old
• Age maximum: 72months-old
• Gender: Male and Female
• Exclude criteria: 1) Need emergency addmission. 2) Under psychological therapy (either mother or child). 3) Serious co-mobidity which may interfare atopic dermatitis. 4) Cannot afford one-night hospital stay. 5) Parents are not involved. 6) In-charge doctor judges.

Related Information

• Primary Sponsor: Gunma Prefectural College of Health Sciences
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology