Clinical trial NCT03504605: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Epilepsy
Asthma
Shame
Self-Compassion
Stress
Perfectionistic Cognitions
Lead sponsor: University of Sheffield
Sponsor class: OTHER
Collaborators: name: Sheffield Children's NHS Foundation Trust
name: Alder Hey Children's Hospital NHS Foundation Trust
name: Chesterfield Royal NHS Foundation Trust
First posted: 2018-04-20
Enrollment: 344
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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).

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.

Primary outcomes:
measure: Self-compassion Scale
timeFrame: Change from baseline trait self-compassion through to study completion (anticipated one week).
measure: PANAS-X
timeFrame: Change from baseline shame through to study completion (anticipated one week).
measure: Self-compassion items
timeFrame: Change from baseline state self-compassion through to study completion (anticipated one week).
Secondary outcomes:
Other outcomes:
measure: Perfectionistic cognitions Inventory
timeFrame: Change from baseline perfectionistic cognitions through to study completion (anticipated one week).
measure: Pediatric Inventory for Parents
timeFrame: Change from baseline parental stress through to study completion (anticipated one week).
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Childrens Hospital
Study officials:
affiliation: University of Sheffield
name: Catherine Lilley
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sheffield
name: Georgina Rowse
role: STUDY_DIRECTOR
affiliation: University of Sheffield
name: Fuschia Sirois
role: STUDY_DIRECTOR
affiliation: University of Sheffield
name: Amrit Sinha
role: STUDY_DIRECTOR
affiliation: University of Sheffield
name: Kirsteen Meheran
role: PRINCIPAL_INVESTIGATOR
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