Staab 2002.

Methods	Design: parallel group design Unit of randomisation: the child Unit of analysis: the child‐parent dyad
Participants	Setting: secondary‐care evening sessions Diagnostic criteria: yes (Hanifin 1980) Age range: 5 months to 12 years Disease severity: Participants had moderate to severe symptoms (SCORAD scale > 20 points) Inclusion criteria of the trial the physician confirmed diagnosis and severity of atopic dermatitis. Participants were to have a SCORAD scale > 20 points and duration of at least 4 months Participants randomised: 204 in total = 93 (intervention) and 111 (control) Mean age: child 2.7 yrs (treatment group) and child 3.4 yrs (control group) Sex: not stated Duration of condition: 2.1 yrs (intervention group) and 2.4 yrs (control group) Severity of condition: SCORAD 44 SD +/‐ 17 (intervention group) and 42 SD +/‐ 15 (control group) Withdrawals Number of: not stated Reason for: not stated Number lost to follow up: 21 (control) and 38 (intervention) ITT analysis: not stated
Interventions	Intervention Nature: parental educational training program Format: group sessions with presentations from various experts Theoretical basis: Frequency: once a week and for 2 hours in an evening session Duration: 6 weeks
Outcomes	Primary outcomes: 1. Disease severity (SCORAD ‐ NB: does not distinguish between objective and subjective scores) 2. Disease‐specific (atopic eczema) parental QoL (untitled) 3. Generic parental QoL (Daily Life Questionnaire) 4. Coping strategies (Trier Scales of Coping) Secondary outcomes: 1. Questionnaire (unspecified), 2 key items: (1) treatment behaviour ‐ regularity of use of skin medication (topical steroids) and help seeking from unconventional treatments (indoor allergy reduction) (and initiated dietary restrictions); (2) direct cost of treatment ‐ calculated costs for previous 6 months and after 1 year
Notes	Group comparability at baseline: yes Conventional topical treatment Allocation concealment: The families in this study were randomly assigned to education or waiting control group. We did not stratify for age or severity. They were enrolled in the randomisation program in the computer by the time of their first evaluation visit. After this visit, they were told in what group they had been allocated Funding source: German Federal Ministry of Education, Science, Research and Technology (no. 01EG9523)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The process was not explained
Allocation concealment (selection bias)	Unclear risk	The process was not explained
Blinding of outcome assessment (detection bias) All outcomes	High risk	Blinding was not possible as most outcome measures were obtained from questionnaires completed by the families who were aware of the group to which they were assigned
Incomplete outcome data (attrition bias) All outcomes	High risk	77% of the intervention group and 66% of the control group were followed up
Selective reporting (reporting bias)	Low risk	The publication reported findings on all outcomes listed in the Methods section
Other bias	Low risk	Results were reported for all outcomes listed in the Methods section, so there was low risk of selective outcome reporting bias