Clinical trial NCT04717284: A Self-compassion Intervention for Parents of Children With Inflammatory Bowel Disease (IBD)
Official title: A Self-compassion Intervention for Parents of Children With Inflammatory Bowel Disease (IBD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Self-compassion
Parental support
Inflammatory Bowel Disease
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: INTRODUCTION:

Inflammatory Bowel Disease (IBD) is a diagnostic term encompassing Crohn's disease (CD) and ulcerative colitis (UC), chronic health conditions (CHCs) characterised by parts of the gut becoming swollen, inflamed and ulcerated. Children with IBD are likely to depend on the support of others, particularly their parents and carers.

Parenting a child with a CHC, such as IBD, has been related to feelings of shame and distress in the literature. Despite this, gaps have been identified in the support offered to parents of children with IBD.

When considering how to target the distress associated with parenting a child with IBD, research suggests that self-compassion interventions may be of particular significance. Despite this, no study to our knowledge has explored the benefits of self-compassion for parents of children with IBD.

The current study therefore aims to investigate the effectiveness of an online self-compassion intervention (SCI) for parents of children with IBD.

AIMS:

Primary Aim: To determine the effectiveness of an online SCI in increasing state self-compassion and reducing state shame and distress in parents of children with IBD.

Secondary Aim: To determine the effectiveness of repeated engagement in the SCI materials in increasing trait self-compassion and reducing parental stress in parents of children with IBD.

HYPOTHESES:

Primary Hypotheses: In comparison to a control group, participants receiving the SCI will: 1) report increased state self-compassion immediately following the SCI; 2) report reduced state shame immediately following the SCI; 3) report reduced state distress immediately following the SCI.

Secondary Hypotheses: In comparison to a control group, participants receiving the SCI will: 4) report increased trait self-compassion after repeated engagement in the SCI materials for two weeks; 5) report reduced parental stress after repeated engagement in the SCI materials for two weeks.

METHODS:

DESIGN: See 'Study Design' for information.

PUBLIC AND PATIENT INVOLVEMENT (PPI): Consultation regarding the suitability and feasibility of the design, outcome measures and materials used for this study has been sought through Crohn's and Colitis UK' s (CCUK) virtual PPI in research day.

PARTICIPANTS: A priori power analysis was conducted using G\*Power 3. This analysis indicated that it would be necessary to recruit 128 participants in total (64 in each condition) in order to detect a medium effect size, with 80% power and a critical p-value of .05. A medium effect size was predicted as a previous similar study found medium to large effect sizes across their results. The power and critical significance levels were set at 0.8 and 0.05 respectively as recommended in psychological research. The target participant number has been inflated by 20% to account for attrition, this means that we will need to recruit 154 participants in total (77 per group). See Enrolment and Eligibility for more participant information.

DATA COLLECTION AND PROCEDURE: Participants will access a Qualtrics® link which will first ask them to read an information sheet, confirm their informed consent and answer a screening question to determine eligibility.

Participants will then be asked to complete a brief demographic questionnaire along with baseline (Time 1 \[T1\]) measures of state self-compassion, state shame, state distress, trait self-compassion and parental stress (presented in a randomised order). Participants will then be asked to recall a recent parenting event they feel ashamed of and type it into a text box. A one-item question will then be administered to assess whether feelings of shame have been elicited by the recall task. The randomiser tool on Qualtrics® will then be used to allocate participants to either a control condition or the SCI (see 'Arms, Groups and Intervention' for more information.). After this initial administration, participants will be asked to complete post-condition (Time 2 \[T2\]) measures of state self-compassion, state shame and state distress to assess for any immediate changes. All participants will then be asked to complete a mood neutralisation task used in previous research to neutralise any potential distress experienced through participation.

Participants in the SCI group will then be asked to engage in the SCI condition every-day for two-weeks. Qualtrics® will be pre-programmed to send participants in this group a daily reminder email during this time which will include a link to a Qualtrics® page containing the instructions and space to engage in the SCI. Participants in the control group will be told they do not need to do anything for two-weeks. After two weeks, Qualtrics® will be pre-programmed to email participants with a link for them to complete follow-up (Time 3 \[T3\]) measures of trait self-compassion and parental stress. Participants in the SCI group will also be presented with a single item to assess participants' adherence to their allocated condition (e.g. 'how often did you engage in the task? every day \[14 days), most days \[10-13 days\], some of the days \[5-9 days\], not many of the days \[1-4 days\], none of the days \[0 days\]').

All participants will then be presented with a debrief information sheet and information on how to access and continue engaging in the SCI materials.

See 'Arms, Groups and Intervention' for more information.

OUTCOME MEASURES: See 'Outcome Measures' for information

DATA SECURITY: A Data Management Plan (DMP) has been completed in accordance with the University of Sheffield's Research Data Management Policy. The DMP describes the data that will be collected and how it will be managed both during and after the research.

PROPOSED DATA ANALYSIS: Preliminary Analysis: Screening, recruitment, random allocation and treatment engagement (including dropout) data will be summarised using a CONSORT diagram. Appropriate descriptive statistics will be reported. Tests to check for necessary assumptions; differences between groups at baseline; and differences between completers and non-completers will also be conducted and reported, with appropriate adjustments made to the following statistical analysis if necessary. A regression analysis will also be conducted to identify any additional predictors of change (e.g. demographic variables, T1 scores) in each of the dependent variables (DV)s at T2 and T3.

Statistical Analysis:

Hypothesis 1: State self-compassion scores at T2 will be compared using a one-way independent ANCOVA, with condition (SCI or control group) as the between groups independent variable (IV). State self-compassion scores at T1 will be included as a covariate, as recommended for pre-post designs assessing for an intervention effect (Field, 2005). As it has been suggested that research exploring SCIs should control for individual differences in self-compassion, baseline trait self-compassion scores will therefore be included as a covariate, along with any other demographic variables or T1 scores that predicted change in this DV at T2.

Hypothesis 2: State shame scores at T2 will be compared using a one-way independent ANCOVA, with condition (SCI or control group) as the between groups IV. As above, state shame scores at T1, as well as trait self-compassion and any other related variables, will be included as covariates.

Hypothesis 3: State distress scores at T2 will be compared using a one-way independent ANCOVA, with condition (SCI or control group) as the between groups IV. As above, state distress scores at T1, as well as trait self-compassion and any other related variables, will be included as covariates Hypothesis 4: Trait self-compassion scores at T3 will be compared using a one-way independent ANCOVA, with condition (SCI or control group) as the between groups IV. As above, trait self-compassion scores at T1, as well as any other related variables, will be included as covariates.

Hypothesis 5: Parental distress scores at T3 will be compared using a one-way independent ANCOVA, with condition (SCI or active-control group) as the between groups IV. As above, parental distress scores at T1, as well as trait self-compassion and any other related variables, will be included as covariates.

\*Both intention-to-treat analysis (including all randomised participants) and per-protocol analysis (only participants who indicate they have engaged in their allocated task for ≥ some of the days \[5-9 days\]) will be ran to enhance interpretations.

Eligibility criteria: 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.

Primary outcomes:
measure: State self-compassion.
timeFrame: Immediately after the initial administration of the self-compassion intervention (SCI) or control condition (Time 2).
measure: State shame and distress.
timeFrame: Immediately after the initial administration of the self-compassion intervention (SCI) or control condition (Time 2).
Secondary outcomes:
measure: Trait self-compassion.
timeFrame: After repeated engagement in the self-compassion intervention (SCI) or nothing for the control group for two weeks (Time 3).
measure: Parental stress.
timeFrame: After repeated engagement in the self-compassion intervention (SCI) or nothing for the control group for two weeks (Time 3).
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Clinical Psychology Unit, University of Sheffield
state: South Yorkshire
Study officials:
affiliation: University of Sheffield
name: A Wray
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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