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CompletedNCT03504605Updated Jul 26, 2019

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

An interventional study of Online self-compassion intervention in Diabetes Mellitus, Type 1, Epilepsy and Asthma, sponsored by University of Sheffield. Completed at 1 site in United Kingdom. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-26.

Sponsored by University of Sheffield · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
344
Allocation
Randomized
Ages
Up to 18 Years
Sex
All
01

Study 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.

Read the 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:

  1. 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.

  2. 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:

  1. 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.
  2. 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.
  3. High levels of shame will relate to lower self-esteem and higher perfectionistic cognitions, with a relationship present over time.
  4. The intervention will be less effective for those high in perfectionistic cognitions (i.e. will be moderated by parents' levels of PCs).
02

Conditions studied

  • Diabetes Mellitus, Type 1
  • Epilepsy
  • Asthma
  • Shame
  • Self-Compassion
  • Stress
  • Perfectionistic Cognitions
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 344 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

University of Sheffield is the lead sponsor of 75 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
344 participants (actual)

Study arms

  • Experimental
    Self-compassion intervention

    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).

    Other: Online self-compassion intervention

  • No intervention
    Control

    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.

Interventions

  • OtherOnline self-compassion intervention

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Change from baseline trait self-compassion through to study completion (anticipated one week).

  2. 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).

    Time frame: Change from baseline shame through to study completion (anticipated one week).

  3. Self-compassion items

    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 outcomes

  1. Perfectionistic cognitions Inventory

    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).

  2. Pediatric Inventory for Parents

    Outcome measure to assess parental stress

    Time frame: Change from baseline parental stress through to study completion (anticipated one week).

07

Study locations

1 site
  • Sheffield Childrens Hospital
    Sheffield, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03504605
Lead sponsor
University of Sheffield
Collaborators
Sheffield Children's NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, Chesterfield Royal NHS Foundation Trust
Responsible party
Catherine Lilley (Principal Investigator, University of Sheffield) — Principal investigator
First posted
Apr 20, 2018
Start date
Aug 15, 2018
Primary completion
Jan 23, 2019
Completion
Jul 25, 2019
Last update
Jul 26, 2019

Study contacts

Catherine Lilley
principal investigator · University of Sheffield
Georgina Rowse
study director · University of Sheffield
Fuschia Sirois
study director · University of Sheffield
Amrit Sinha
study director · University of Sheffield
Kirsteen Meheran
principal investigator · University of Sheffield

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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