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Impact of Parental Perfectionistic Cognitions Self-compassion Intervention Effects on Shame in Child Health Context

Primary Purpose

Diabetes Mellitus, Type 1, Epilepsy, Asthma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Online self-compassion intervention
Sponsored by
University of Sheffield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Parents (mothers and fathers, biological or non-biological) with a child under 18 years and living with them)
  • Parents with children with a medical diagnosis of Type 1 diabetes mellitus, asthma, or epilepsy.

Exclusion Criteria:

  • Parents and / or children who are currently receiving or who have engaged in therapy for stress related issues, with regards to the child's diagnosis.
  • Parents who don't have access to a computer.
  • Parents who have difficulties with reading.
  • Parents who aren't fluent in English.

Sites / Locations

  • Sheffield Childrens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-compassion intervention

Control

Arm Description

Participants will be asked to recall and write (in an online text-box) about a parenting event during which they felt shame. They will then receive the online self-compassion intervention as detailed in Sirois, Bögels and Emerson (in revision). This involves parents in the experimental condition being given a validated set of instructions asking them to reflect on the event and write self-compassionate responses (see intervention).

Participants will be asked to recall and write (in an online text-box) about a parenting event during which they felt shame. Those in the control condition will be asked to re-read the account of the event and make notes about factual information (e.g. time of day, who was there, etc.). It should be noted that if the SCI is found to reduce state shame and increase state self-compassion, it will be offered to participants in the control group.

Outcomes

Primary Outcome Measures

Self-compassion Scale
Outcome measure to assess trait self-compassion, which is defined as a trait in which people are mindful to emotions and respond towards themself with kindness and with a sense of common humanity, through difficulties, or following perceived failure/ personal shortcomings
PANAS-X
Outcome measure to assess shame, defined as a self-conscious emotion, distinct from guilt as it is constructed of negative evaluation directed towards the self (as opposed to behaviours).
Self-compassion items
An adapted outcome measure to assess state self-compassion, defined as self-compassion that can change in the moment.

Secondary Outcome Measures

Full Information

First Posted
April 6, 2018
Last Updated
July 25, 2019
Sponsor
University of Sheffield
Collaborators
Sheffield Children's NHS Foundation Trust, Alder Hey Children's Hospital NHS Foundation Trust, Chesterfield Royal NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03504605
Brief Title
Impact of Parental Perfectionistic Cognitions Self-compassion Intervention Effects on Shame in Child Health Context
Official Title
The Role of Parental Perfectionistic Cognitions in an Intervention to Improve Self- Compassion and Reduce Shame: Findings in the Context of Child Chronic Health Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
January 23, 2019 (Actual)
Study Completion Date
July 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sheffield
Collaborators
Sheffield Children's NHS Foundation Trust, Alder Hey Children's Hospital NHS Foundation Trust, Chesterfield Royal NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Parents of children with long-term health conditions (LTCs) can experience shame related to parenting. Whilst self-compassion interventions (SCIs) can reduce parental shame, this has not been studied with parents of children with LTCs. Perfectionistic cognitions may also moderate the effects of SCIs. This study will test an online SCI with parents of children with type 1 diabetes, epilepsy or asthma. Parents will complete online questionnaires pre- and post a SCI/control intervention. Hypotheses will be tested using analysis of covariance and moderation analysis. Findings will enhance knowledge of vulnerability factors to distress for parents of children with LTCs, and inform interventions.
Detailed Description
This study is part of a joint project being conducted in the University of Sheffield by another Trainee Clinical Psychologist. The studies use the same baseline, but only this study includes a clinical trial. Parents of children with long-term health conditions (LTCs) can experience shame related to parenting. Whilst self-compassion interventions (SCIs) have been shown to reduce parental shame, this has not been studied with parents of children with LTCs. Evidence also suggests that perfectionistic cognitions may moderate the effects of SCIs. This study will test an online SCI with parents of children with type 1 diabetes, epilepsy or asthma. This design of the study is experimental and prospective. The methodology is made up of two parts: Baseline data collection period: Baseline measures of perfectionistic cognitions, state and trait self-compassion, state shame and parental stress relating to their child's LTC will be taken, alongside demographic information regarding the participant's age, gender, their child's type of LTC and duration of illness (which research indicates affects levels of self-compassion or perfectionistic cognitions). At baseline, all participants will also be asked to give their email contact details. Qualtrics will be set up to randomise participants' emails into one of two groups at baseline so that participants can be allocated to one of the follow-up studies. Follow-up experimental study: Eligible participants will be randomised (as described above) into this experimental follow-up study or that of the other Trainee Clinical Psychologist. On entry to this study they will be further randomised via Qualtrics into an experimental (self-compassion intervention) or control group. Both groups will be asked to recall and write (in an online text-box) about a parenting event during which they felt shame. Those in the experimental group will receive the online self-compassion intervention as detailed in Sirois, Bögels and Emerson (in revision). This involves parents in the experimental condition being given a validated set of instructions asking them to reflect on the event and write self-compassionate responses. Participants in the control condition will be asked to re-read the account of the event and make notes about factual information (e.g. time of day, who was there, etc.). Measures of state and trait self-compassion, shame and parental stress related to their child's LTC will be repeated immediately after the intervention. The parent will then complete a mood neutralisation task (requiring them to write about a time that they felt proud of their parenting). Parents randomised to the control condition will receive the self-compassion intervention retrospectively, if results indicate it was effective. Hypotheses: Parents of children with a chronic health condition will report reduced state shame associated with parenting after the self-compassion intervention, compared with those in the control condition. Parents of children with a chronic health condition will report an increase in state self-compassion after the self-compassion intervention, compared with those in the control condition. High levels of shame will relate to lower self-esteem and higher perfectionistic cognitions, with a relationship present over time. The intervention will be less effective for those high in perfectionistic cognitions (i.e. will be moderated by parents' levels of PCs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Epilepsy, Asthma, Shame, Self-Compassion, Stress, Perfectionistic Cognitions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
344 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-compassion intervention
Arm Type
Experimental
Arm Description
Participants will be asked to recall and write (in an online text-box) about a parenting event during which they felt shame. They will then receive the online self-compassion intervention as detailed in Sirois, Bögels and Emerson (in revision). This involves parents in the experimental condition being given a validated set of instructions asking them to reflect on the event and write self-compassionate responses (see intervention).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will be asked to recall and write (in an online text-box) about a parenting event during which they felt shame. Those in the control condition will be asked to re-read the account of the event and make notes about factual information (e.g. time of day, who was there, etc.). It should be noted that if the SCI is found to reduce state shame and increase state self-compassion, it will be offered to participants in the control group.
Intervention Type
Other
Intervention Name(s)
Online self-compassion intervention
Intervention Description
Parents are asked to write in an online text box about a parenting event in which they felt shame. They are then given a validated set of instructions asking them to reflect on the event and write self-compassionate responses.
Primary Outcome Measure Information:
Title
Self-compassion Scale
Description
Outcome measure to assess trait self-compassion, which is defined as a trait in which people are mindful to emotions and respond towards themself with kindness and with a sense of common humanity, through difficulties, or following perceived failure/ personal shortcomings
Time Frame
Change from baseline trait self-compassion through to study completion (anticipated one week).
Title
PANAS-X
Description
Outcome measure to assess shame, defined as a self-conscious emotion, distinct from guilt as it is constructed of negative evaluation directed towards the self (as opposed to behaviours).
Time Frame
Change from baseline shame through to study completion (anticipated one week).
Title
Self-compassion items
Description
An adapted outcome measure to assess state self-compassion, defined as self-compassion that can change in the moment.
Time Frame
Change from baseline state self-compassion through to study completion (anticipated one week).
Other Pre-specified Outcome Measures:
Title
Perfectionistic cognitions Inventory
Description
Outcome measure to assess automatic perfectionistic thoughts, defined as automatic thoughts to do with perfection. They are included in this study as potential moderator of the impact of the intervention on shame and self-compassion.
Time Frame
Change from baseline perfectionistic cognitions through to study completion (anticipated one week).
Title
Pediatric Inventory for Parents
Description
Outcome measure to assess parental stress
Time Frame
Change from baseline parental stress through to study completion (anticipated one week).

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parents (mothers and fathers, biological or non-biological) with a child under 18 years and living with them) Parents with children with a medical diagnosis of Type 1 diabetes mellitus, asthma, or epilepsy. Exclusion Criteria: Parents and / or children who are currently receiving or who have engaged in therapy for stress related issues, with regards to the child's diagnosis. Parents who don't have access to a computer. Parents who have difficulties with reading. Parents who aren't fluent in English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Lilley
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georgina Rowse
Organizational Affiliation
University of Sheffield
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fuschia Sirois
Organizational Affiliation
University of Sheffield
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amrit Sinha
Organizational Affiliation
University of Sheffield
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kirsteen Meheran
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Childrens Hospital
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Parental Perfectionistic Cognitions Self-compassion Intervention Effects on Shame in Child Health Context

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