NCT03873142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

March 4, 2019

Last Update Submit

September 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Demographic information

    1-time point (baseline period)

  • Mindful parenting

    4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later) end of intervention (8 weeks later) follow-up (8 weeks later)

  • Parental Stress

    4 time-points. Baseline (beginning of study) beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)

  • Parental Anxiety

    4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)

  • Parental Depression

    4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)

  • +5 more secondary outcomes

Study Arms (1)

Mindful parenting intervention

EXPERIMENTAL

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.

Behavioral: Mindful Parenting

Interventions

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.

Mindful parenting intervention

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Barnsley Hospital NHS Foundation Trust

Barnsley, South Yorkshire, United Kingdom

Location

The University of Sheffield

Sheffield, South Yorkshire, S12LT, United Kingdom

Location

Sheffield Children's Hospital

Sheffield, South Yorkshire, United Kingdom

Location

Doncaster Royal Infirmary

Doncaster, United Kingdom

Location

Rotherham Hospital

Sheffield, United Kingdom

Location

Related Publications (10)

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

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

    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.

    PMID: 17300244BACKGROUND
  • Bögels, S., & Restifo, K. (2013). Mindful parenting: A guide for mental health practitioners. Springer Science & Business Media.

    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.

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

    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.

    PMID: 7662573BACKGROUND
  • 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.

    PMID: 7726811BACKGROUND
  • 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.

    PMID: 10568646BACKGROUND
  • 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.

    PMID: 16717171BACKGROUND

MeSH Terms

Conditions

PsoriasisEczema

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesDermatitisSkin Diseases, Eczematous

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No party will be masked in this study. There is only one arm and participants will act as their own controls.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 13, 2019

Study Start

October 19, 2018

Primary Completion

July 18, 2019

Study Completion

August 22, 2019

Last Updated

October 1, 2019

Record last verified: 2019-09

Locations