The Effectiveness of a Mindful Parenting Intervention for Parents of Children With Psoriasis and Parents of Children With Eczema
Primary Purpose
Psoriasis, Eczema, Stress
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mindful Parenting
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
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.
Sites / Locations
- Barnsley Hospital NHS Foundation Trust
- The University of Sheffield
- Sheffield Children's Hospital
- Doncaster Royal Infirmary
- Rotherham Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindful parenting intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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").
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")
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").
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")
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").
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").
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").
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")
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").
Full Information
NCT ID
NCT03873142
First Posted
March 4, 2019
Last Updated
September 30, 2019
Sponsor
University of Sheffield
Collaborators
The Psoriasis and Psoriatic Arthritis Alliance
1. Study Identification
Unique Protocol Identification Number
NCT03873142
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
July 18, 2019 (Actual)
Study Completion Date
August 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sheffield
Collaborators
The Psoriasis and Psoriatic Arthritis Alliance
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Eczema, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Masking Description
No party will be masked in this study. There is only one arm and participants will act as their own controls.
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindful parenting intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Parenting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in parenting stress (idiosyncratic measure)
Description
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.
Time Frame
Daily for 20 weeks (baseline-intervention-follow-up)
Secondary Outcome Measure Information:
Title
Demographic information
Description
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.
Time Frame
1-time point (baseline period)
Title
Mindful parenting
Description
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").
Time Frame
4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later) end of intervention (8 weeks later) follow-up (8 weeks later)
Title
Parental Stress
Description
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")
Time Frame
4 time-points. Baseline (beginning of study) beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Title
Parental Anxiety
Description
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").
Time Frame
4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Title
Parental Depression
Description
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")
Time Frame
4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Title
General Stress
Description
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").
Time Frame
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)
Title
Parental quality of life
Description
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").
Time Frame
Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Title
Paediatric quality of life
Description
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").
Time Frame
Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Title
Paediatric psoriasis/eczema severity
Description
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")
Time Frame
2 time-points. Baseline (beginning of study), follow-up (18 weeks later)
Title
Paediatric psoriasis/eczema itch intensity
Description
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").
Time Frame
2 time-points. Baseline (beginning of study), follow-up (18 weeks later)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Barnsley Hospital NHS Foundation Trust
City
Barnsley
State/Province
South Yorkshire
Country
United Kingdom
Facility Name
The University of Sheffield
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S12LT
Country
United Kingdom
Facility Name
Sheffield Children's Hospital
City
Sheffield
State/Province
South Yorkshire
Country
United Kingdom
Facility Name
Doncaster Royal Infirmary
City
Doncaster
Country
United Kingdom
Facility Name
Rotherham Hospital
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
Abidin, R. R. (1995). Parenting stress index 3rd edition: Professional manual. Psychological Assessment Resources, Inc, Odessa, TX.
Results Reference
background
Citation
Abidin R. R. (2012) Parenting Stress Index. Odessa, FL: Psychological Assessment Resources.
Results Reference
background
PubMed Identifier
17300244
Citation
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. Erratum In: Br J Dermatol. 2007 Apr;156(4):791.
Results Reference
background
Citation
Bögels, S., & Restifo, K. (2013). Mindful parenting: A guide for mental health practitioners. Springer Science & Business Media.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Kabat-Zinn, J. (1990). Full catastrophe living. New York: Bantam Doubleday Dell.
Results Reference
background
PubMed Identifier
7662573
Citation
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.
Results Reference
background
PubMed Identifier
7726811
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. doi: 10.1016/0005-7967(94)00075-u.
Results Reference
background
PubMed Identifier
10568646
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. doi: 10.1001/jama.282.18.1737.
Results Reference
background
PubMed Identifier
16717171
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.
Results Reference
background
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The Effectiveness of a Mindful Parenting Intervention for Parents of Children With Psoriasis and Parents of Children With Eczema
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