Clinical trial NCT05779527: Mindful Parenting - A Single Case Experimental Design Study
Official title: A Single Case Experimental Design Study of an Online Mindful-parenting Intervention for Parents of Children Living With a Visible Difference
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parenting
Alopecia
Skin Condition
Limb Difference
Neurofibromatoses
Craniofacial
Cleft Lip and Palate
Lead sponsor: Cardiff University
Sponsor class: OTHER
Collaborators: name: University of Canterbury
First posted: 2023-03-22
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Case Experimental Design
Primary purpose: TREATMENT

Brief summary: Some parents of children living with a visible difference can experience heightened stress due to the associated challenges of this. Parent's views of the child's visible difference and their responses to the child are important. Mindful parenting approaches have been found to reduce stress or distress for parents of children with disabilities, physical health problems and skin conditions.

This study will be completed with a small number of participants (around six to 12). Participants will be parents or carers of a child living with a visible difference aged four to 16 years, who are experiencing stress. Parents or carers will complete an online mindful parenting intervention (called Two Hearts) including video content, audio files and a workbook, over six weeks. Over the twelve-week study period participants will also provide the following information which will be compared over time:

* Complete four group support sessions during the intervention via videoconferencing
* Complete questionnaires at four timepoints
* Provide information about their use of the intervention materials and home practice weekly
* Answer two questions daily via text message about parenting stress levels We hope to learn about the initial effects of the mindful parenting programme for parents or carers of children living with a visible difference. We also hope to learn whether parents or carers find completing an online programme possible and practical. Finally, we hope to learn what parents' or carers' views are of the online programme and whether this type of intervention in online format would be helpful for other parents or carers.

Detailed description: Aims

* To investigate the feasibility, acceptability, and initial effects of an online mindful parenting intervention for parents of children living with a visible difference.
* To investigate whether the intervention reduces parenting stress.
* To investigate whether completion of the intervention results in increased levels of mindful parenting.
* To investigate whether completion of the mindful parenting intervention has an impact upon child wellbeing.
* To investigate the feasibility of an online mindful parenting intervention for parents of children living with a visible difference, including adherence to the intervention, attrition, and participant perceptions of the acceptability of the intervention.

Hypotheses

* Completion of the intervention will result in changes in idiographic measures of parental stress. Namely, an improvement in the positive target and a reduction in the negative target. These improvements will be maintained on follow up.
* Completion of the intervention will result in reductions of parental stress on standardised assessment measures. These improvements will be maintained on follow up.
* Completion of the intervention will result in an improvement in child wellbeing on standardised assessment measures. These improvements will be maintained on follow up.
* Completion of the intervention will increase levels of mindful parenting as measured using a standardised assessment measure. These improvements will be maintained on follow up.
* Increased levels of mindful parenting will be associated with improved outcomes on idiographic and standardised assessment measures.

Methodology Design This study will adopt an A-B-A2 single case experimental design . Phase A will consist of a two-week baseline period. Phase B will be the six-week intervention. Phase A2 will be a four-week follow up period and an exit interview. The main outcome variable will be general parenting stress and parenting stress associated with the child's visible difference, measured idiographically via daily text messages. Secondary outcome variables will comprise standardised assessment measures of mindful parenting, parenting stress and parent reported child wellbeing. Feasibility of the online intervention will be assessed through recording of practical issues such as access to online content, participant adherence to the intervention (including home practice) and participant retention. Acceptability of the intervention will be assessed via participant evaluations of the workbook, online content, home practice and intervention overall through weekly feedback and the exit interview.

Participants The aim will be to recruit between six and 12 participants. Single case series methodology usually comprises only a small number of participants as each participant acts as their own control and provide large amounts of data.

Screening interview All participants will complete a screening interview to assess suitability for the intervention. During the screening interview the participants will be asked about 1. The nature of their child's visible difference, 2. Their access to a tablet or computer to complete the intervention, 3. Whether the parent is currently accessing any psychological therapy, 4. Parental mental health and stress (current and over the past year) including the use of medications, 5. Parental experience of mindfulness or meditation. Information obtained from the screening interview will be used to assess eligibility for the study, based on the above criteria.

Measures Demographic data Demographic information will be gathered at the beginning of the study. Parents will be asked to report their age, gender, ethnicity, education background; as well as their child's age, gender and nature of the visible difference (i.e. skin condition, mark, injury etc.) and part of the child's body affected.

Daily Idiographic measures of parenting stress Two unique targets identified by each participant around parenting stress will be measured daily on a scale of 1-100.

Standardised assessment measures Participants will be asked to complete standardised questionnaire measures at four timepoints: on baseline, immediately prior to beginning the intervention, immediately on completion and at follow up (four weeks after intervention completion).

Intervention engagement, home practice and retention Adherence and attrition will be recorded. Weekly feedback will be collected from participants regarding levels of engagement with the intervention and mindfulness home practice.

Intervention evaluation The acceptability of the intervention will be assessed through the following. An evaluation questionnaire will be used to assess parents' experiences of the Two Hearts Mindful Parenting intervention based on those developed by Bogels and Restifo for their Mindful Parenting programme. Parents will also complete an exit interview. Exit interviews will be audio recorded, or notes will be taken in line with participant preference. Where interviews are recorded these will be transcribed verbatim within six weeks of completion and then deleted.

Procedure Participants will first be interviewed via telephone to assess suitability. If the participant is suitable for the intervention, they will be directed to the online consent forms. If the participant choses to participate, then the researcher will support the parent to identify two target idiographic measures of parenting stress. A secure online text messaging service will be used to collect these measures from parents daily from baseline. Participants will be asked to complete standardised assessment measures through the online platform Qualtrics at four timepoints (baseline, immediately prior to starting the intervention, immediately on completion of the intervention and at four week follow up). Participants will be asked to provide weekly feedback regarding their engagement with the intervention materials and home practice. Participants will be able to begin the online intervention when enough participants have been recruited and at least two weeks after they complete their baseline measures. On completion of the follow up period participants will be asked to complete an exit interview.

Recruitment strategy Charitable foundations such as Changing Faces, Cleft Lip and Palate Association (CLAPA), the Children's Burns Trust (CBT), Headlines Craniofacial Support, and Ichthyosis Support Group, based in the UK, will be invited to share our recruitment advert and a link to our study information sheet on their social media pages and websites. Snowball sampling will be enabled to allow wide distribution.

Intervention The Two Hearts mindful parenting is an online programme based on the Mindful Parenting programme developed by Bogels \& Restifo and was developed by an expert panel (L-M. Emerson, S. Bögels, J. Paynter). The intervention has been piloted with parents from a community population. In this pilot study the intervention was found to be acceptable to parents. Intervention retention was 100%, however adherence to home practice was variable. Reductions in parenting stress and increased levels of mindfulness were reported for half of the participants. The Mindful Parenting intervention will be free for participants. Parents only will complete the intervention.

The Two Hearts programme comprises four self-directed online modules, which involve video and audio recorded content supported by a parent workbook (Introduction, Mindful Awareness in Parenting, Mindful Parenting in Action, Compassion in Parenting). The introductory module will consist of a brief PDF document alongside an audio file to support home practice. All three other modules consist of a series of two to four short videos to be accessed via an appropriate online platform, reading from the Parent Workbook and audio files to support mindfulness practices. Mindfulness practices include three-minute breathing space and mindful movement.

The intervention period will begin when enough participants have been recruited and around two-weeks after participants complete baseline measures. Intervention content is to be hosted on an online platform and parents will be able to access one module at a time over the six-week intervention period. Participants will be encouraged to engage in regular mindfulness home practice.

Participants will be supported to engage with the intervention via text message reminders twice a week during the six-week intervention period and once per week during the four-week follow up period. Four group support sessions (videoconferencing) will be scheduled at the start of the programme (introduction) after week two, week four and week six. These sessions will be organised with participants in small groups (or individually if necessary). Participants will be sent a link to the group support sessions via email. Sessions will be conducted via videoconferencing. No data will be collected during these sessions other than attendance data, and they will not be recorded. At the beginning of group support sessions issues of confidentiality (and it's limits) and group conduct will be discussed. Support sessions are intended to help participants overcome any barriers to engaging with the intervention materials or completing home practice. Attendance data will be linked with anonymised participant numbers on a secure database.

Data Analysis

Idiographic data:

Idiographic data will be organised in excel and observed in a graph and analysed visually to identify trends, variability and data patterns.

Idiographic data will be analysed with Tau-U via an online calculator. Tau-U examines data non-overlap between study phases (baseline, intervention, follow-up). Baseline scores will initially be analysed for trend and any significant trend will be corrected for. Weighted averages will be calculated.

Secondary outcome data:

Differences between phases (baseline, intervention, and follow up) on secondary outcome measures will be examined using Jacobson's reliable change index. The distribution of scores on these measures will be gathered from existing literature to generate reliable change criteria. Analyses will be completed employing the Leeds Reliable Change Indicator .

Evaluation data:

Quantitative intervention engagement data, evaluation form data and exit interview data will be tabulated. Descriptive analyses and frequencies will be reported. Thematic analysis will be used to identify themes from qualitative exit interview data.

Eligibility criteria: Inclusion Criteria:

* Parents aged over 16 years, of children aged between four (4)-16 years living with a visible difference
* All types and aetiologies of child visible differences including any scarring, condition, disability, or mark that affects a person's appearance, with confirmation via self-report
* Parent experiencing self-reported stress associated with the child's visible difference
* Able to communicate in verbal and written English
* Access to a computer/tablet with an active internet connection

Exclusion Criteria:

* Parent currently accessing psychological therapy for their own wellbeing, including parenting programmes
* Parent experiencing active thoughts of suicide or self-injury
* Parent experienced a psychotic episode or engaged in deliberate self-injury over the past year
* Parent commenced medications for mood in the last two months
* Parent previously accessed a mindful parenting intervention
* Child currently in an acute phase following a physical injury
* Only one parent or carer per household can take part

Primary outcomes:
measure: Parenting Stress (unique to each participant)
timeFrame: Day 1
measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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measure: Parenting Stress (unique to each participant)
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Secondary outcomes:
measure: Parenting Stress Index 4th Edition Short Form
timeFrame: Baseline
measure: Parenting Stress Index 4th Edition Short Form
timeFrame: Pre-intervention (week 2)
measure: Parenting Stress Index 4th Edition Short Form
timeFrame: Post-intervention (week 8)
measure: Parenting Stress Index 4th Edition Short Form
timeFrame: Follow up (week 12)
measure: Interpersonal Mindfulness in Parenting scale
timeFrame: Baseline
measure: Interpersonal Mindfulness in Parenting scale
timeFrame: Pre-intervention (week 2)
measure: Interpersonal Mindfulness in Parenting scale
timeFrame: Post-intervention (week 8)
measure: Interpersonal Mindfulness in Parenting scale
timeFrame: Follow up (week 12)
measure: Strengths and Difficulties questionnaire (SDQ)
timeFrame: Baseline
measure: Strengths and Difficulties questionnaire (SDQ)
timeFrame: Pre-intervention (week 2)
measure: Strengths and Difficulties questionnaire (SDQ)
timeFrame: Post-intervention (week 8)
measure: Strengths and Difficulties questionnaire (SDQ)
timeFrame: Follow up (week 12)
Other outcomes:
measure: Participant evaluation of the Mindful Parenting Programme
timeFrame: Follow up (week 12)
measure: Exit interview to gather feedback on participant experience of participation in the study
timeFrame: Follow up (week 12)
measure: Levels of participant engagement with intervention materials and home practice exercises
timeFrame: Week 3
measure: Levels of participant engagement with intervention materials and home practice exercises
timeFrame: Week 4
measure: Levels of participant engagement with intervention materials and home practice exercises
timeFrame: Week 5
measure: Levels of participant engagement with intervention materials and home practice exercises
timeFrame: Week 6
measure: Levels of participant engagement with intervention materials and home practice exercises
timeFrame: Week 7
measure: Levels of participant engagement with intervention materials and home practice exercises
timeFrame: Week 8
Locations:
city: Cardiff
country: United Kingdom
facility: Cardiff University
Study officials:
affiliation: Cardiff University
name: Professor Thompson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abidin, R. (2012). Parenting Stress Index-Fourth Edition (PSI-4). Lutz, FL: Psychological Assessment Resources.
citation: Bögels, S., & Restifo, K. (2013). Mindful parenting: A guide for mental health practitioners. Springer Science & Business Media.
citation: Dempsey L, Dowling M, Larkin P, Murphy K. Sensitive Interviewing in Qualitative Research. Res Nurs Health. 2016 Dec;39(6):480-490. doi: 10.1002/nur.21743. Epub 2016 Jul 19.
citation: Emerson, L. M., Aktar, E., de Bruin, E., Potharst, E., & Bögels, S. (2019). Mindful Parenting in Secondary Child Mental Health: Key Parenting Predictors of Treatment Effects. Mindfulness, 1-11.
citation: Heapy C, Norman P, Emerson LM, Murphy R, Bogels S, Thompson AR. Mindful parenting intervention for parents of children with skin conditions: a single group experimental cases series. Behav Cogn Psychother. 2022 Sep;50(5):462-480. doi: 10.1017/S1352465822000170. Epub 2022 Apr 25.
citation: Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.
citation: Kabat-Zinn, J. (2013). Full Catastrophe Living, Revised Edition: How to Cope with Stress, Pain and Illness Using Mindfulness Meditation: Hachette uK.
citation: Morley, S., & Dowzer, C. (2014). The Leeds Reliable Change Indicator. University of Leeds.
citation: Parker RI, Vannest KJ, Davis JL, Sauber SB. Combining nonoverlap and trend for single-case research: Tau-U. Behav Ther. 2011 Jun;42(2):284-99. doi: 10.1016/j.beth.2010.08.006. Epub 2011 Feb 3.
citation: Sherwood, A. (2020). Mindful Parenting Brief Online Intervention: Exploring Program Feasibility and Initial Effects. Griffith University Gold Coast,
citation: Vannest, K. J., Parker, R. I., Gonen, O., & Adiguzel, T. (2016). Single Case Research: Web Based Calculators for Scr Analysis. Retrieved from http://www.singlecaseresearch.org/