NCT04717284

Brief Summary

Parenting a child with Inflammatory Bowel Disease (IBD) can understandably be challenging and distressing at times. The aim of this study is therefore to investigate the effectiveness of an online self-compassion intervention (SCI), that focuses on helping individuals respond to themselves in a kinder and more accepting way, for parents of children with IBD. Around 150 parents of children with IBD will be randomly allocated to receive either the online SCI or a control condition. This will involve an initial administration and a two-week follow-up period. Participants will complete outcome measures of self-compassion, distress and shame at three time points. We hypothesise that, in comparison to a control group, participants receiving the online SCI will: (1) report increased state self-compassion and reduced state shame and distress immediately following the SCI; and (2) report increased trait self-compassion and reduced parental stress after repeated engagement in the SCI materials for two weeks. Through understanding the effectiveness of an online SCI for parents of children with IBD, we hope that our research will help to inform and improve parental support offered to parents of children with IBD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

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

December 7, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2021

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

December 7, 2020

Last Update Submit

April 27, 2022

Conditions

Keywords

Self-compassionParental supportInflammatory Bowel Disease

Outcome Measures

Primary Outcomes (2)

  • State self-compassion.

    Five items developed and used by a similar study based on previous research will be used to assess state self-compassion. Participants will use a 7-point Likert scale to rate how they feel 'right now' on items corresponding to the three components of self-compassion: self-kindness; common humanity; and mindfulness. A total score is generated by reversing negative items and calculating a mean of all item scores. The minimum score is 1 and the maximum score is 7. A higher total score indicates greater state self-compassion.

    Immediately after the initial administration of the self-compassion intervention (SCI) or control condition (Time 2).

  • State shame and distress.

    Fourteen items from the Positive and Negative Affect Schedule Expanded Form (PANAS-X) that make up two subscales of guilt and negative affect will be used to assess state shame and distress respectively. Participants will be asked to use a 5-point Likert scale to rate what extent they are experiencing feelings related to shame and distress 'right now (that is, at the present moment)'. A total score for each subscale is calculated by summing the relevant item responses, with higher scores on each subscale indicating greater state shame and distress respectively. The guilt subscale used to assess state shame yields a minimum score of 6 and a maximum score of 30. The negative affect subscale used to assess distress yields a minimum score of 10 and a maximum score of 50.

    Immediately after the initial administration of the self-compassion intervention (SCI) or control condition (Time 2).

Secondary Outcomes (2)

  • Trait self-compassion.

    After repeated engagement in the self-compassion intervention (SCI) or nothing for the control group for two weeks (Time 3).

  • Parental stress.

    After repeated engagement in the self-compassion intervention (SCI) or nothing for the control group for two weeks (Time 3).

Study Arms (2)

Self-compassion intervention (SCI)

EXPERIMENTAL

Self-compassion prompt.

Other: Self-compassion intervention (SCI)

Control condition

OTHER

Neutral prompt during the initial administration and no intervention during the two-week follow-up.

Other: Control condition

Interventions

All participants will be asked to recall a recent parenting event they feel ashamed of and type it into a text box provided. Participants in the SCI group will then be instructed to reflect on their recalled parenting event and prompted to think about and write about the event in a self-compassionate manner. The prompt is designed to induce on all of the three key elements of self-compassion described by Neff (2003a): self-kindness; common humanity; and mindfulness. The same instructions will be provided for follow-up period.

Self-compassion intervention (SCI)

All participants will be asked to recall a recent parenting event they feel ashamed of and type it into a text box provided. Participants in the control group will then be instructed to make notes about factual information of the event (e.g. time of day, who was there, the weather, etc.). During the two-week follow-up period, participants in the control group will not take part in any intervention as part of the trial.

Control condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parental responsibility stated.
  • Children must be under 18 years old and residing with the parent.
  • Children must be diagnosed with IBD.

You may not qualify if:

  • \- Not able to read and write in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Psychology Unit, University of Sheffield

Sheffield, South Yorkshire, S1 2LT, United Kingdom

Location

Related Publications (6)

  • Sirois FM, Bogels S, Emerson LM. Self-compassion Improves Parental Well-being in Response to Challenging Parenting Events. J Psychol. 2019;153(3):327-341. doi: 10.1080/00223980.2018.1523123. Epub 2018 Oct 30.

    PMID: 30376651BACKGROUND
  • Watson, D., & Clark, L. A. (1994). The PANAS-X: Manual for the positive and negative affect schedule - expanded form. The University of Iowa. https://www2.psychology.uiowa.edu/faculty/clark/panas-x.pdf

    BACKGROUND
  • Breines JG, Chen S. Self-compassion increases self-improvement motivation. Pers Soc Psychol Bull. 2012 Sep;38(9):1133-43. doi: 10.1177/0146167212445599. Epub 2012 May 29.

    PMID: 22645164BACKGROUND
  • Neff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and Identity, 2(3), 223-250. https://doi.org/10.1080/15298860309027

    BACKGROUND
  • Streisand R, Braniecki S, Tercyak KP, Kazak AE. Childhood illness-related parenting stress: the pediatric inventory for parents. J Pediatr Psychol. 2001 Apr-May;26(3):155-62. doi: 10.1093/jpepsy/26.3.155.

    PMID: 11259517BACKGROUND
  • Neff, K. D. (2003). Self-compassion: An alternative conceptualization of a healthy attitude toward oneself. Self and Identity, 2(2), 85-101. https://doi.org/10.1080/15298860309032

    BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • A Wray

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2020

First Posted

January 22, 2021

Study Start

April 20, 2021

Primary Completion

December 11, 2021

Study Completion

December 11, 2021

Last Updated

April 28, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

Anonymous survey data will be deposited in Online Research Data (ORDA; the University of Sheffield data repository), Unidrive (shared drive that has limited access - myself, Research Support Officer, certain members of Psychology department), and an open access data repository (if a condition to publication specified by a journal). Participants will be asked to provide consent for their anonymous survey data to be shared in this way.

Time Frame
Data to be deposited in ORDA and Unidrive after completion of the research project (by September 2022). This will be temporarily embargoed, until the research has been published. Whilst embargoed, contact details will be provided for others to request access if appropriate.
Access Criteria
Whilst data is embargoed prior to publication, contact details will be provided for others to request access if appropriate. Following publication, access to this data will not be restricted.

Locations