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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873142
• Other study ID #: 249150
• Status: Completed
• Phase: N/A
• Start date: October 19, 2018
• Est. completion date: August 22, 2019

Study information

• Verified date: September 2019
• Source: University of Sheffield
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 22, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eczema
• Psoriasis
• Stress

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United Kingdom	Barnsley Hospital NHS Foundation Trust	Barnsley	South Yorkshire
United Kingdom	Doncaster Royal Infirmary	Doncaster
United Kingdom	Rotherham Hospital	Sheffield
United Kingdom	Sheffield Children's Hospital	Sheffield	South Yorkshire
United Kingdom	The University of Sheffield	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Sheffield	The Psoriasis and Psoriatic Arthritis Alliance

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

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

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

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. Erratum in: Br J Dermatol. 2007 Apr;156(4):791. — View Citation

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

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.

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

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. — View Citation

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. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in parenting stress (idiosyncratic measure)	The primary outcome measures for the proposed study are idiosyncratic measures of stress which will be assessed daily by text message. Participants will be asked to identify one stress-related positive target (something the participant would like to improve) and one negative target (something the participant would like to reduce). Participants will respond to the daily text messages with a score on a 0-100 scale.	Daily for 20 weeks (baseline-intervention-follow-up)
Secondary	Demographic information	Parents will be asked to provide information about their age, gender, ethnicity, relationship to child, employment status, marital status, education level, child's age, and child's gender.	1-time point (baseline period)
Secondary	Mindful parenting	The Interpersonal Mindfulness in Parenting scale (IM-P; Duncan, 2007) will be used to ascertain the level of mindful parenting of the parents. This self-report questionnaire measures affective, cognitive and attitudinal aspects of parent-child relationships. There are 10 items covering one higher order mindful parenting factor and four first-order factors: 1) present-centered attention in parenting; 2) present-centered emotional awareness in parenting; 3) non-reactivity/low-reactivity in parenting; and 4) non-judgmental acceptance in parenting. Items are rated on five-point Likert scales (from "never true" to "always true").	4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later) end of intervention (8 weeks later) follow-up (8 weeks later)
Secondary	Parental Stress	The Parenting Stress Index - Short Form (PSI-SF; Abidin, 1995) will be used to assess parental stress. This 36-item self-report measure assesses parental stress over three factors (parental distress, dysfunctional parent-child interactions, and difficult child) and one total stress factor (Abidin, 2012). Items are rated on a 5-point Likert scale (from "strongly agree" to "strongly disagree")	4 time-points. Baseline (beginning of study) beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Secondary	Parental Anxiety	The Generalised Anxiety Disorder Questionnaire (GAD-7; Spitzer, Kroenke & Williams, 2006) is a 7-item self-report scale to measure generalized anxiety symptoms. Items are rated on a 4-point Likert scale (from "not at all" to "nearly everyday").	4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Secondary	Parental Depression	The Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Willams, 1999) is a 9-item questionnaire assessing symptoms of depression. Items are rated on a 4-point Likert scale (from "not at all" to "nearly everyday")	4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Secondary	General Stress	The stress subscale of the Depression Anxiety and Stress Scale (DASS-21: Lovibond & Lovibond, 1995) will be used to assess general stress levels of parents. Items are rated on 4-point Likert scale (from "never" to "almost always").	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)
Secondary	Parental quality of life	The Family Dermatology Life Quality Index (FDLQI: Basra, Su-Ho, & Finlay, 2007) will be used to measure parental quality of life. This self-report measure comprises 10 items assessing a range of ways that a family member's skin condition may impact upon an individual's quality of life, covering two factors (psychosocial impact and physical impact). Items are rated on a 4-point Likert scale (ranging from "not at all" to "very much").	Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Secondary	Paediatric quality of life	The Children's Dermatology Life Quality Index (CDLQI: Lewis-Jones & Finlay, 1995) will be used to assess paediatric quality of life. This self-report measure is completed by the child, and comprises 10-items assessing a range of ways that a child's skin condition may impact upon their quality of life, covering 6 areas (symptoms and feelings, leisure, school or holidays, personal relationships, sleep, treatment). Items are rated on a 4-point Likert scale (ranging from "not at all" to "very much").	Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Secondary	Paediatric psoriasis/eczema severity	Children will be asked to indicate the itch intensity of the psoriasis/eczema, on a 10-point scale (from "not at all itchy" to "the worst itchy imaginable")	2 time-points. Baseline (beginning of study), follow-up (18 weeks later)
Secondary	Paediatric psoriasis/eczema itch intensity	Children will be asked to indicate the itch intensity of the psoriasis/eczema, on a 10-point scale (from "not at all bad/severe" to "extremely bad/severe").	2 time-points. Baseline (beginning of study), follow-up (18 weeks later)