Does integrating a parenting support program into paediatric eczema care services improve treatment outcomes? A randomised controlled trial.

Not Applicable

• Conditions: Atopic dermatitis (eczema) in children; Parenting children with atopic dermatitis (eczema); Skin - Dermatological conditions

• Registration Number: ACTRN12618001332213
• Lead Sponsor: Dr Amy Mitchell

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-07
• Study Completion: 2021-02-04
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Parents of 2- to 10-year-old children with eczema who are currently prescribed topical corticosteroids and attending dermatology outpatient clinics at the Lady Cilento Children's Hospital (Brisbane).

Exclusion Criteria

The child has a disability, including language and speech impairment.
The parents are currently seeing a professional for the child’s behaviour difficulties.
The parents are currently receiving psychological help or counselling.
The parents have previously completed Triple P.
The parents have difficulties in reading an English newspaper.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease severity: Atopic dermatitis (eczema) severity will be assessed via visual assessment using the Eczema Area Severity Index (EASI), and via parent-report of symptom severity using the Patient Orientated Eczema Measure (POEM).[Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up. ];Treatment Adherence: Use of topical eczema medications, assessed using the Medication Event Monitoring System (MEMS) 6 TrackCaps.[Daily adherence will be monitored for the duration of participation in the study, beginning 1 month prior to randomisation and continuing until 6-month follow-up.]

Secondary Outcome Measures

Name	Time	Method
Parenting behaviour, as assessed using the Parenting Scale.[Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up. ];Atopic dermatitis (eczema) management, as assessed using the Child Eczema Management Questionnaire.[Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up. ];Child behaviour, as assessed using the Eczema Behaviour Checklist.[Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up. ];Quality of life, as assessed using the Child Dermatology Life Quality Index (child) and the Dermatitis Family Impact Questionnaire (family).[Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up. ]