Trial Title:
Mindful Parenting - A Single Case Experimental Design Study
NCT ID:
NCT05779527
Condition:
Parenting
Alopecia
Skin Condition
Limb Difference
Neurofibromatoses
Craniofacial
Cleft Lip and Palate
Conditions: Official terms:
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Cleft Lip
Alopecia
Skin Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single Case Experimental Design
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Mindful Parenting Programme
Description:
Online Mindful Parenting Programme with group support sessions
Arm group label:
Online Mindful Parenting Programme
Other name:
Two Hearts
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.
Criteria for 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
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Cardiff University
Address:
City:
Cardiff
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Abigail Clifton, BSc
Phone:
029 20 870 582
Email:
cliftona3@cardiff.ac.uk
Contact backup:
Last name:
Professor Thompson
Phone:
029 20 870 582
Email:
thompsona18@cardiff.ac.uk
Start date:
January 3, 2023
Completion date:
April 14, 2023
Lead sponsor:
Agency:
Cardiff University
Agency class:
Other
Collaborator:
Agency:
University of Canterbury
Agency class:
Other
Source:
Cardiff University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05779527
