The Effectiveness of a Mindful Parenting Intervention for Parents of Children With Psoriasis and Parents of Children With Eczema

NCT ID: NCT03873142

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-19

Study Completion Date

2019-08-22

Brief Summary

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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

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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.

Conditions

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Psoriasis Eczema Stress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

No party will be masked in this study. There is only one arm and participants will act as their own controls.

Study Groups

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Mindful parenting intervention

There is only one arm in this study. A range of variables will first be measured (daily and weekly) over a baseline period in a group of participants. Following this baseline period, participants will be take part in a mindful parenting intervention whilst the same variables are measured. Following the intervention, there will be an 8-week follow-up period, and mindful parenting groups will not run during this time.

Group Type EXPERIMENTAL

Mindful Parenting

Intervention Type BEHAVIORAL

The mindful parenting intervention is an adaption for parents of the Mindfulness-Based Cognitive Therapy (MBCT) for depression (Kabat-Zinn, 1990), and the Mindful-Based Stress Reduction program (MBSR; Kabat-Zinn, 1990). The mindful parenting intervention will follow the manual developed by Bögels and Restifo (2014). The intervention consists of 9x3hour sessions. Eight of these sessions are run on consecutive weeks and the final session is run eight weeks after the eighth session. These groups involve group discussions around parenting, meditation exercises, and yoga, amongst other things.

Interventions

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Mindful Parenting

The mindful parenting intervention is an adaption for parents of the Mindfulness-Based Cognitive Therapy (MBCT) for depression (Kabat-Zinn, 1990), and the Mindful-Based Stress Reduction program (MBSR; Kabat-Zinn, 1990). The mindful parenting intervention will follow the manual developed by Bögels and Restifo (2014). The intervention consists of 9x3hour sessions. Eight of these sessions are run on consecutive weeks and the final session is run eight weeks after the eighth session. These groups involve group discussions around parenting, meditation exercises, and yoga, amongst other things.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 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

Exclusion Criteria

\- N/A


* 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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Psoriasis and Psoriatic Arthritis Alliance

UNKNOWN

Sponsor Role collaborator

University of Sheffield

OTHER

Sponsor Role lead

Responsible Party

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Andrew Thompson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Barnsley Hospital NHS Foundation Trust

Barnsley, South Yorkshire, United Kingdom

Site Status

The University of Sheffield

Sheffield, South Yorkshire, United Kingdom

Site Status

Sheffield Children's Hospital

Sheffield, South Yorkshire, United Kingdom

Site Status

Doncaster Royal Infirmary

Doncaster, , United Kingdom

Site Status

Rotherham Hospital

Sheffield, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Abidin, R. R. (1995). Parenting stress index 3rd edition: Professional manual. Psychological Assessment Resources, Inc, Odessa, TX.

Reference Type BACKGROUND

Abidin R. R. (2012) Parenting Stress Index. Odessa, FL: Psychological Assessment Resources.

Reference Type BACKGROUND

Basra MK, Sue-Ho R, Finlay AY. The Family Dermatology Life Quality Index: measuring the secondary impact of skin disease. Br J Dermatol. 2007 Mar;156(3):528-38. doi: 10.1111/j.1365-2133.2006.07617.x.

Reference Type BACKGROUND
PMID: 17300244 (View on PubMed)

Bögels, S., & Restifo, K. (2013). Mindful parenting: A guide for mental health practitioners. Springer Science & Business Media.

Reference Type BACKGROUND

Duncan, L. G. (2007). Assessment of mindful parenting among parents of early adolescents: Development and validation of the Interpersonal Mindfulness in Parenting scale. The Pennsylvania State University.

Reference Type BACKGROUND

Kabat-Zinn, J. (1990). Full catastrophe living. New York: Bantam Doubleday Dell.

Reference Type BACKGROUND

Lewis-Jones MS, Finlay AY. The Children's Dermatology Life Quality Index (CDLQI): initial validation and practical use. Br J Dermatol. 1995 Jun;132(6):942-9. doi: 10.1111/j.1365-2133.1995.tb16953.x.

Reference Type BACKGROUND
PMID: 7662573 (View on PubMed)

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

Reference Type BACKGROUND
PMID: 7726811 (View on PubMed)

Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.

Reference Type BACKGROUND
PMID: 10568646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16717171 (View on PubMed)

Other Identifiers

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249150

Identifier Type: -

Identifier Source: org_study_id

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