Table 3.
The schedule of enrolment, interventions and assessments
| Pre-group screening | Baseline assessment | Allocation | Post-intervention assessment | 6-week follow-up assessment | |
| Time point (week) | 0 | 0 | 2 | 8 | 14 |
| Enrolment | |||||
| Eligibility screening | ⚫ | ||||
| Informed consent | ⚫ | ||||
| Allocation | ⚫ | ||||
| Interventions | |||||
| I-BMS intervention for parents and children (arm 1) | ⚫ | ⚫ | ⚫ | ⚫ | |
| I-BMS intervention for parents only (arm 2) | ⚫ | ⚫ | ⚫ | ⚫ | |
| Health education for parents only (arm 3) | ⚫ | ⚫ | ⚫ | ⚫ | |
| Assessments | |||||
| Primary outcomes | |||||
| Quality of life (FDLQI, CDLQI) | ⚫ | ⚫ | ⚫ | ||
| Emotional regulation (CERQ-SV, CERQ-SK-SV) | ⚫ | ⚫ | ⚫ | ||
| Secondary outcomes | |||||
| Depression and anxiety (HADS, RCADS-SV) | ⚫ | ⚫ | ⚫ | ||
| Stress (PSS, PSS-C) | ⚫ | ⚫ | ⚫ | ||
| Parent–child relationship (PRS-PF, PRS-CF) | ⚫ | ⚫ | ⚫ | ||
|
Clinical information on childhood AD (including POEM) |
◯ | ◯ | ◯ | ||
| Other measures | |||||
| Demographics | ⚫ | ||||
| Intervention evaluation (STP) | ◯ | ||||
| Cross-condition contamination check | ✪ | ||||
⚫=parents and children; ◯=parents only; ✪=parents in arm 3 only.
AD, atopic dermatitis; CDLQI, Children’s Dermatology Life Quality Index; CERQ-SK-SV, Cognitive Emotion Regulation Questionnaire for Spanish Kids-Short Version; CERQ-SV, Cognitive Emotion Regulation Questionnaire-Short Version; FDLQI, Family Dermatology Life Quality Index; HADS, Hospital Anxiety and Depression Scale; I-BMS, Integrative Body–Mind–Spirit; POEM, Patient-Oriented Eczema Measure for Child (Parent Form); PRS-CF, Personal Relationship Subscale (Child Form); PRS-PF, Personal Relationship Subscale (Parent Form); PSS, Perceived Stress Scale; PSS-C, Perceived Stress Scale for Children; RCADS-SV, Revised Child Anxiety and Depression Scale-Short Version; STP, Satisfaction with Treatment Program Scale.