Diabetes Mellitus, Type 1NCT03504605
Impact of Parental Perfectionistic Cognitions Self-compassion Intervention Effects on Shame in Child Health Context
A study testing Online self-compassion intervention in people with Diabetes Mellitus, Type 1 and Epilepsy, run by University of Sheffield at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Epilepsy, Asthma
- What is being tested?
- Online self-compassion intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2018to 25 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- 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).
- Conditions
- Diabetes Mellitus, Type 1, Epilepsy, Asthma, Shame, Self-Compassion, Stress
- Being tested
- Online self-compassion intervention
- Medical subject headings
- Diabetes Mellitus, Type 1, Epilepsy, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online self-compassion interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-compassion intervention | Experimental | 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). Receives: Other: Online self-compassion intervention |
| Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline trait self-compassion through to study completion (anticipated one week).
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).
Measured: Change from baseline shame through to study completion (anticipated one week).
Self-compassion items
An adapted outcome measure to assess state self-compassion, defined as self-compassion that can change in the moment.
Measured: Change from baseline state self-compassion through to study completion (anticipated one week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start15 Aug 2018
- Primary completion23 Jan 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Children's NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, Chesterfield Royal NHS Foundation Trust
- Responsible party
- Principal investigator, Catherine Lilley, University of Sheffield
- Investigators
- Catherine Lilley, Principal investigator, University of SheffieldGeorgina Rowse, Study director, University of SheffieldFuschia Sirois, Study director, University of SheffieldAmrit Sinha, Study director, University of SheffieldKirsteen Meheran, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504605
- Sponsor's protocol ID
- 155657
- Status last verified
- Jul 2019
- First submitted
- 6 Apr 2018
- Last updated
- 26 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03504605
- Acronym / sponsor ID
- 155657
- Conditions
- Diabetes Mellitus, Type 1, Epilepsy, Asthma, Shame, Self-Compassion, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- Sheffield Children's NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, Chesterfield Royal NHS Foundation Trust
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-compassion intervention | Experimental | Other: Online self-compassion interventionParticipants 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). |
| Control | No 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online self-compassion interventionParents 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. | Other | Self-compassion intervention |
Primary outcome
Self-compassion Scale
Time frame: Change from baseline trait self-compassion through to study completion (anticipated one week).
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
Time frame: Change from baseline shame through to study completion (anticipated one week).
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
Time frame: Change from baseline state self-compassion through to study completion (anticipated one week).
An adapted outcome measure to assess state self-compassion, defined as self-compassion that can change in the moment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Lilley principal investigator
University of Sheffield
Georgina Rowse study director
University of Sheffield
Fuschia Sirois study director
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online self-compassion intervention in people with Diabetes Mellitus, Type 1 and Epilepsy, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-compassion Scale (time frame: Change from baseline trait self-compassion through to study completion (anticipated one week).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.