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Parents or carers will be invited to complete a six week online mindful parenting programme comprising online video, audio and written content plus four group support sessions via videoconferencing.

Online Mindful Parenting Programme with group support sessions

Mindful Parenting Programme

Abigail Clifton, BSc

Professor Thompson

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.

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.

Mindful Parenting - A Single Case Experimental Design Study

A Single Case Experimental Design Study of an Online Mindful-parenting Intervention for Parents of Children Living With a Visible Difference

An evaluation questionnaire will be used to assess parents' experiences of the Two Hearts Mindful Parenting intervention based on those developed by previous authors. Questions include: "Do you feel you've got something of lasting value of importance because of taking the training?", adherence to home practice "On average, how many times a week did you practice the meditation exercises during the course?", and perceived importance/ value of specific elements of the intervention "body scan".

Questions will include: "What was your experience of the video content of the intervention?", "What was your experience of the support sessions?", "Are there any practices in you plan to take forwards beyond the end of the study?", "Have you noticed any changes in their self-compassion?", and "What changes, if any, have you noticed in the way you interact with your child?".

Adherence and attrition will be recorded. Feedback will be collected from participants regarding levels of engagement with the intervention and mindfulness home practice. Participants will provide this information via text message giving the number of minutes spent on each reading intervention materials and engaging with home practice.

Parents will identify two targets for desired change around parenting stress related to the child's visible difference. It is intended that participants will identify one target area for improvement (positive target) and one for reduction (negative target). Questions will be rated on a scale of 0 (not at all) to 100 (extremely). Idiographic measures will be completed via text message. Text messages will be sent via a secure online provider (PageOne's Janet txt). Example targets include: be more present in interactions with my child and be grumpy or respond abruptly with my child less.

Measure of Parenting Stress with total stress reported on a scale of 36-180 and higher scores being indicative of higher levels of stress.

Measure of Mindful Parenting measured on a scale of 31-155 for total mindfulness with higher scores indicative of higher levels of mindful parenting.

Parent reported child wellbeing measure with scores ranging from 0-40 with higher scores being indicative of higher levels of difficulty on all subscales other than the prosocial subscale.

University of Canterbury

Cardiff University

Skin Abnormalities

Skin Neoplasms

To investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health

VIO System

The overall objective of this study is to investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health.

Non-Linear Imaging of Skin In Vivo

Non-Linear Imaging of Skin In Vivo: VIO In Vivo Skin Imaging evaluatiON (VISION)

Quantify imaging performance in various types of skin, which may include estimated in vivo resolution and imaging depth. Various types of skin includes skin of different people as well as skin in different locations on the body, and skin with skin disease, including basal cell carcinoma.

VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device imaging performance (acceptable/not acceptable) was assessed through engineering expert review of VIO images. The engineering expert review determined whether images were of consistent quality.

Qualitatively evaluate image quality and interpretability by physicians trained in dermatopathology as a function of skin type.

VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device image quality (acceptable/not acceptable) was assessed through clinical expert review of VIO images. The clinical expert review determined whether VIO images could be interpreted by physicians trained in dermatopathology.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Enspectra Health

Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics

VIO Imaging

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Fitzpatrick skin type is a demographic measure of skin pigment and sensitivity to sunlight, as self-reported by participants prior to the study procedure. The measure ranges from Type I (least pigment/most sensitive) to Type VI (most pigment/least sensitive). Refer to PubMed ID: 29461771 for the scale used.

Fitzpatrick Skin Type

Healthy

Suspected or known skin diseases

Skin Health

President

VIO System Imaging Performance assessment was conducted on images taken of all participants

VIO System Imaging Performance

VIO System Image Quality assessment was conducted on images taken of all participants

VIO System Image Quality

Overall Study

Subjects with skin conditions that are candidates for biopsy

Skin conditions that are candidates for skin biopsies

Michael Wang, MD, FAAD

To demonstrate the safety and effectiveness of the VIO device in obtaining in vivo images that show tissue features including epidermis, dermis, collagen, blood vessels, and/or pigment.

To demonstrate that the tissue features identified on the images obtained with the VIO device align with the corresponding pathology images procured from the skin biopsy.

To evaluate the ability of blinded readers to correctly identify tissue features on images obtained with the VIO device.

VIO Imaging for Skin Tissue Assessment (VISTA)

VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy

1. 100% agreement and validation of specific tissue features on VIO images (epidermis, dermis, collagen, blood vessels and pigment) in comparison to gold standard pathology images in Comparative Reader assessment.

2. \>90% agreement between Blinded Reader VIO image assessment and answer key developed from validation assessment.

3. Safety will be assessed as the incidence of all adverse events (analyzed by severity, seriousness, and relationship to the device and procedure) that occur through the 7-day follow-up period.

1) 90% inter-reader agreement during image analysis

Evaluation of secondary histopathology characteristics using a questionnaire to identify skin features on the images captured on the investigational device VIO; including but not limited to

* Dermal elastosis
* Cellular nodules within dermis will be evaluated during image analysis
* Large keratinocytes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mindful Parenting - A Single Case Experimental Design Study	NCT05779527	Parenting Alopecia Skin Condition Limb Difference Neurofibromatos... Craniofacial Cleft Lip and P...	Mindful Parenti...	16 Years -	Cardiff University
Mindful Parenting - A Single Case Experimental Design Study	NCT05779527	Parenting Alopecia Skin Condition Limb Difference Neurofibromatos... Craniofacial Cleft Lip and P...	Mindful Parenti...	16 Years -	Cardiff University
Non-Linear Imaging of Skin In Vivo	NCT05410964	Skin Cancer Skin Condition Skin Diseases Skin Lesion Skin Abnormalit...	VIO System	2 Years - 90 Years	Enspectra Health
Non-Linear Imaging of Skin In Vivo	NCT05410964	Skin Cancer Skin Condition Skin Diseases Skin Lesion Skin Abnormalit...	VIO System	2 Years - 90 Years	Enspectra Health
VIO Imaging for Skin Tissue Assessment (VISTA)	NCT05619471	Skin Condition Skin Diseases Skin Lesion Skin Abnormalit... Skin Cancer	VIO Imaging	18 Years - 99 Years	Enspectra Health

Spots Global Cancer Trial Database for skin condition