A Self-compassion Intervention for Parents of Children With Inflammatory Bowel Disease (IBD)
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ClinicalTrials.gov Identifier: NCT04717284 |
Recruitment Status :
Completed
First Posted : January 22, 2021
Last Update Posted : April 28, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Inflammatory Bowel Diseases | Other: Self-compassion intervention (SCI) Other: Control condition | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 159 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Self-compassion Intervention for Parents of Children With Inflammatory Bowel Disease (IBD) |
Actual Study Start Date : | April 20, 2021 |
Actual Primary Completion Date : | December 11, 2021 |
Actual Study Completion Date : | December 11, 2021 |
Arm | Intervention/treatment |
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Experimental: Self-compassion intervention (SCI)
Self-compassion prompt.
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Other: 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 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. |
Control condition
Neutral prompt during the initial administration and no intervention during the two-week follow-up.
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Other: Control condition
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. |
- State self-compassion. [ Time Frame: Immediately after the initial administration of the self-compassion intervention (SCI) or control condition (Time 2). ]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.
- State shame and distress. [ Time Frame: Immediately after the initial administration of the self-compassion intervention (SCI) or control condition (Time 2). ]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.
- Trait self-compassion. [ Time Frame: After repeated engagement in the self-compassion intervention (SCI) or nothing for the control group for two weeks (Time 3). ]The 26-item Self-Compassion Scale (SCS) will be used to assess parent's trait self-compassion. Participants will use a 5-point Likert scale to rate how often they respond in different ways to assess each of the dimensions of self-compassion. Six subscale scores based on each of the dimensions are computed by calculating the mean of relevant item responses. A total score is generated by reversing negative items and calculating a mean of all six subscale means. The total and subscale scores will be a minimum of 1 and a maximum of 5. Higher total and subscale scores indicate greater trait self-compassion.
- Parental stress. [ Time Frame: After repeated engagement in the self-compassion intervention (SCI) or nothing for the control group for two weeks (Time 3). ]The Pediatric Inventory for Parents (PIP) will be used to assess parental stress. Participants will use a 5-point Likert scale to rate both the frequency and difficulty of 42 items related to caring for children with CHCs. The measure generates separate scores of stress frequency (F) and difficulty (D) across four domains: Communication; Medical Care; Role Functioning; and Emotional Distress, as well as total frequency (Total-F) and total difficulty (Total-D) scores. For the Total-F and Total-D, the minimum score is 42 and the maximum score is 210. In all cases, higher scores indicate greater illness-related parental stress.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Parental responsibility stated.
- Children must be under 18 years old and residing with the parent.
- Children must be diagnosed with IBD.
Exclusion Criteria:
- Not able to read and write in English.
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): NCT04717284
United Kingdom | |
Clinical Psychology Unit, University of Sheffield | |
Sheffield, South Yorkshire, United Kingdom, S1 2LT |
Principal Investigator: | A Wray | University of Sheffield |
Responsible Party: | University of Sheffield |
ClinicalTrials.gov Identifier: | NCT04717284 |
Other Study ID Numbers: |
169973 |
First Posted: | January 22, 2021 Key Record Dates |
Last Update Posted: | April 28, 2022 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Self-compassion Parental support Inflammatory Bowel Disease |
Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |