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

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ClinicalTrials.gov Identifier: NCT03504605
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
Sheffield Children's NHS Foundation Trust
Alder Hey Children's Hospital NHS Foundation Trust
Chesterfield Royal NHS Foundation Trust
Information provided by (Responsible Party):
Catherine Lilley, University of Sheffield

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Epilepsy Asthma Shame Self-Compassion Stress Perfectionistic Cognitions Other: Online self-compassion intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

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.



Primary Outcome Measures :
  1. 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

  2. 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).

  3. 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.


Other Outcome Measures:
  1. Perfectionistic cognitions Inventory [ Time Frame: Change from baseline perfectionistic cognitions through to study completion (anticipated one week). ]
    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.

  2. Pediatric Inventory for Parents [ Time Frame: Change from baseline parental stress through to study completion (anticipated one week). ]
    Outcome measure to assess parental stress



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504605


Contacts
Contact: Catherine A Lilley 07590470817 clilley2@sheffield.ac.uk

Sponsors and Collaborators
University of Sheffield
Sheffield Children's NHS Foundation Trust
Alder Hey Children's Hospital NHS Foundation Trust
Chesterfield Royal NHS Foundation Trust
Investigators
Principal Investigator: Catherine Lilley University of Sheffield
Study Director: Georgina Rowse University of Sheffield
Study Director: Fuschia Sirois University of Sheffield
Study Director: Amrit Sinha University of Sheffield
Principal Investigator: Kirsteen Meheran University of Sheffield

Responsible Party: Catherine Lilley, Principal Investigator, University of Sheffield
ClinicalTrials.gov Identifier: NCT03504605     History of Changes
Other Study ID Numbers: 155657
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases