Clinical trial NCT03873142: The Effectiveness of a Mindful Parenting Intervention for Parents of Children With Psoriasis and Parents of Children With Eczema
Official title: The Effectiveness of a Mindful Parenting Intervention for Parents of Children With Psoriasis and Parents of Children With Eczema: A Single Group Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Eczema
Stress
Lead sponsor: University of Sheffield
Sponsor class: OTHER
Collaborators: name: The Psoriasis and Psoriatic Arthritis Alliance
First posted: 2019-03-13
Enrollment: 14
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-group case-series design will be adopted, whereby one group of participants will complete daily and weekly measures over the course of 1) a 2-week baseline period; 2) an 8-week intervention period; 3) an 8-week follow up period. Variables collected during the intervention and follow-up period will be compared with those from the baseline period.
Primary purpose: TREATMENT

Brief summary: This study investigates the impact of a mindful parenting intervention on parents of children with psoriasis or eczema. More specifically, this study will investigate the impact of the group on both the child and the parents mental health and quality of life.

Detailed description: Psoriasis and eczema are chronic inflammatory skin conditions that affect up to 2% and 20% of children respectively (Mahe, 2016; Plötz, Wiesender, Todorva \& Ring, 2014). These skin conditions are associated with poorer mental health in the children themselves and in their parents (Megna et al., 2015; Hammer-Helmich et al., 2016). Little research has investigated ways of reducing parental stress in parents of children with chronic health conditions, such as psoriasis and eczema.

"Mindful Parenting" interventions offer one potential way of improving mental health and quality of life in parents and their children. Mindful parenting refers to a parenting style which involves paying close, non-judgemental attention to the child (Duncan et al., 2009). However, no research has investigated the impact of mindful parenting interventions on children with skin conditions and their parents.

The main aim of the current study is to investigate whether a mindful parenting intervention can improve mental health and quality of life in children with psoriasis/eczema and their parents. A single-group case-series design will be adopted, whereby participants will act as their own control; data collected from participants during and after they have received the intervention will be compared to data collected before they have received the intervention. Interviews will also be conducted after the intervention, to explore participants experience of the group.

The investigators predict that the intervention will improve mental health and quality of life in children with psoriasis/eczema and their parents. More specifically, we predict:

* There will be a reduction in negative parental idiosyncratic measures of stress throughout the intervention phase, in comparison to baseline phase, that will be maintained in the follow-up phase.
* There will be an improvement in positive parental idiosyncratic measures of stress during the intervention phase in comparison to baseline phase that will be maintained in the follow-up phase.
* There will be a significant increase in levels of mindful parenting following the intervention phase, in comparison to baseline phase, that will be maintained in the follow-up phase.
* There will be a significant decrease in levels of parental stress at end of intervention phase compared to baseline phase that will be maintained in the follow-up phase.
* There will be a significant increase in parental quality of life and paediatric quality of life at the end of intervention phase compared to baseline phase that will be maintained in the follow-up phase .
* There will be a significant improvement in psoriasis severity and itch at the follow-up phase compared to the baseline phase.

Eligibility criteria: Child inclusion criteria:

* Received a diagnosis of psoriasis or eczema from a medical professional
* Aged 4-16 years
* Fluent English speaker
* Psoriasis or eczema is the primary health concern

Parent inclusion criteria:

* Parent of child (aged four to 16 years old) with psoriasis or eczema
* Aged 16 or over
* Self-identifies as experiencing stress due to the child's skin condition
* Fluent English Speaker
* Able and willing to attend 9 group sessions
* Willing to commit sufficient time to carrying out the practice (e.g. at home)
* Willing to respond to daily brief text messages

Child exclusion criteria:

- N/A

Parent exclusion criteria:

* Active thoughts of suicide
* Active thoughts of self-harm
* Engaging in, or about to start, psychological therapy during the study period
* Previously attended a mindful parenting group
* Recent severe life events such as deliberate self-harm, hospital admission, or psychotic episode (last 12 months)
* Experiencing physical pain or problems that may be worsened by yoga exercises.

Primary outcomes:
measure: Change in parenting stress (idiosyncratic measure)
timeFrame: Daily for 20 weeks (baseline-intervention-follow-up)
Secondary outcomes:
measure: Demographic information
timeFrame: 1-time point (baseline period)
measure: Mindful parenting
timeFrame: 4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later) end of intervention (8 weeks later) follow-up (8 weeks later)
measure: Parental Stress
timeFrame: 4 time-points. Baseline (beginning of study) beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
measure: Parental Anxiety
timeFrame: 4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
measure: Parental Depression
timeFrame: 4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
measure: General Stress
timeFrame: 5 time-points. Screening interview (pre-study), baseline (beginning of study, approx. 2-4 weeks later), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
measure: Parental quality of life
timeFrame: Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
measure: Paediatric quality of life
timeFrame: Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
measure: Paediatric psoriasis/eczema severity
timeFrame: 2 time-points. Baseline (beginning of study), follow-up (18 weeks later)
measure: Paediatric psoriasis/eczema itch intensity
timeFrame: 2 time-points. Baseline (beginning of study), follow-up (18 weeks later)
Other outcomes:
Locations:
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
state: South Yorkshire
city: Sheffield
country: United Kingdom
facility: The University of Sheffield
state: South Yorkshire
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
state: South Yorkshire
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
city: Sheffield
country: United Kingdom
facility: Rotherham Hospital
Study officials:
References:
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citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.