NCT03504605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

April 6, 2018

Last Update Submit

July 25, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    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).

    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.

    Change from baseline state self-compassion through to study completion (anticipated one week).

Other Outcomes (2)

  • Perfectionistic cognitions Inventory

    Change from baseline perfectionistic cognitions through to study completion (anticipated one week).

  • Pediatric Inventory for Parents

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

Study Arms (2)

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).

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.

Interventions

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.

Self-compassion intervention

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Childrens Hospital

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1EpilepsyAsthma

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivity

Study Officials

  • Catherine Lilley

    University of Sheffield

    PRINCIPAL INVESTIGATOR
  • Georgina Rowse

    University of Sheffield

    STUDY DIRECTOR
  • Fuschia Sirois

    University of Sheffield

    STUDY DIRECTOR
  • Amrit Sinha

    University of Sheffield

    STUDY DIRECTOR
  • Kirsteen Meheran

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2018

First Posted

April 20, 2018

Study Start

August 15, 2018

Primary Completion

January 23, 2019

Study Completion

July 25, 2019

Last Updated

July 26, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations