PsoriasisNCT03873142
The Effectiveness of a Mindful Parenting Intervention for Parents of Children With Psoriasis and Parents of Children With Eczema
A study testing Mindful Parenting in people with Psoriasis and Eczema, run by University of Sheffield at 5 sites in United Kingdom.
Trial summary
This study investigates the impact of a mindful parenting intervention on parents of children with psoriasis or eczema. More specifically, this study will investigate the impact of the group on both the child and the parents mental health and quality of life. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- What is being tested?
- Mindful Parenting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 19 Oct 2018to 22 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Child inclusion criteria:
- Received a diagnosis of psoriasis or eczema from a medical professional
- Aged 4-16 years
- Fluent English speaker
- Psoriasis or eczema is the primary health concern
Parent inclusion criteria:
- Parent of child (aged four to 16 years old) with psoriasis or eczema
- Aged 16 or over
- Self-identifies as experiencing stress due to the child's skin condition
- Fluent English Speaker
- Able and willing to attend 9 group sessions
- Willing to commit sufficient time to carrying out the practice (e.g. at home)
- Willing to respond to daily brief text messages
Child exclusion criteria:
- N/A
Parent exclusion criteria:
- Active thoughts of suicide
- Active thoughts of self-harm
- Engaging in, or about to start, psychological therapy during the study period
- Previously attended a mindful parenting group
- Recent severe life events such as deliberate self-harm, hospital admission, or psychotic episode (last 12 months)
- Experiencing physical pain or problems that may be worsened by yoga exercises.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire
Doncaster Royal Infirmary
Doncaster
The University of Sheffield
Sheffield, South Yorkshire, S12LT
Sheffield Children's Hospital
Sheffield, South Yorkshire
Rotherham Hospital
Sheffield
About this study
Official title: The Effectiveness of a Mindful Parenting Intervention for Parents of Children With Psoriasis and Parents of Children With Eczema: A Single Group Case Series
This study investigates the impact of a mindful parenting intervention on parents of children with psoriasis or eczema. More specifically, this study will investigate the impact of the group on both the child and the parents mental health and quality of life.
Read the detailed description
Psoriasis and eczema are chronic inflammatory skin conditions that affect up to 2% and 20% of children respectively (Mahe, 2016; Plötz, Wiesender, Todorva \& Ring, 2014). These skin conditions are associated with poorer mental health in the children themselves and in their parents (Megna et al., 2015; Hammer-Helmich et al., 2016). Little research has investigated ways of reducing parental stress in parents of children with chronic health conditions, such as psoriasis and eczema.
"Mindful Parenting" interventions offer one potential way of improving mental health and quality of life in parents and their children. Mindful parenting refers to a parenting style which involves paying close, non-judgemental attention to the child (Duncan et al., 2009). However, no research has investigated the impact of mindful parenting interventions on children with skin conditions and their parents.
The main aim of the current study is to investigate whether a mindful parenting intervention can improve mental health and quality of life in children with psoriasis/eczema and their parents. A single-group case-series design will be adopted, whereby participants will act as their own control; data collected from participants during and after they have received the intervention will be compared to data collected before they have received the intervention. Interviews will also be conducted after the intervention, to explore participants experience of the group.
The investigators predict that the intervention will improve mental health and quality of life in children with psoriasis/eczema and their parents. More specifically, we predict:
- There will be a reduction in negative parental idiosyncratic measures of stress throughout the intervention phase, in comparison to baseline phase, that will be maintained in the follow-up phase.
- There will be an improvement in positive parental idiosyncratic measures of stress during the intervention phase in comparison to baseline phase that will be maintained in the follow-up phase.
- There will be a significant increase in levels of mindful parenting following the intervention phase, in comparison to baseline phase, that will be maintained in the follow-up phase.
- There will be a significant decrease in levels of parental stress at end of intervention phase compared to baseline phase that will be maintained in the follow-up phase.
- There will be a significant increase in parental quality of life and paediatric quality of life at the end of intervention phase compared to baseline phase that will be maintained in the follow-up phase .
- There will be a significant improvement in psoriasis severity and itch at the follow-up phase compared to the baseline phase.
- Being tested
- Mindful Parenting
- Medical subject headings
- Psoriasis, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful ParentingBehavioural
The mindful parenting intervention is an adaption for parents of the Mindfulness-Based Cognitive Therapy (MBCT) for depression (Kabat-Zinn, 1990), and the Mindful-Based Stress Reduction program (MBSR; Kabat-Zinn, 1990). The mindful parenting intervention will follow the manual developed by Bögels and Restifo (2014). The intervention consists of 9x3hour sessions. Eight of these sessions are run on consecutive weeks and the final session is run eight weeks after the eighth session. These groups involve group discussions around parenting, meditation exercises, and yoga, amongst other things.
| Study group | Role | What they receive |
|---|---|---|
| Mindful parenting intervention | Experimental | There is only one arm in this study. A range of variables will first be measured (daily and weekly) over a baseline period in a group of participants. Following this baseline period, participants will be take part in a mindful parenting intervention whilst the same variables are measured. Following the intervention, there will be an 8-week follow-up period, and mindful parenting groups will not run during this time. Receives: Behavioral: Mindful Parenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parenting stress (idiosyncratic measure)
The primary outcome measures for the proposed study are idiosyncratic measures of stress which will be assessed daily by text message. Participants will be asked to identify one stress-related positive target (something the participant would like to improve) and one negative target (something the participant would like to reduce). Participants will respond to the daily text messages with a score on a 0-100 scale.
Measured: Daily for 20 weeks (baseline-intervention-follow-up)
Secondary outcomes (10)
Demographic information
Parents will be asked to provide information about their age, gender, ethnicity, relationship to child, employment status, marital status, education level, child's age, and child's gender.
Measured: 1-time point (baseline period)
Mindful parenting
The Interpersonal Mindfulness in Parenting scale (IM-P; Duncan, 2007) will be used to ascertain the level of mindful parenting of the parents. This self-report questionnaire measures affective, cognitive and attitudinal aspects of parent-child relationships. There are 10 items covering one higher order mindful parenting factor and four first-order factors: 1) present-centered attention in parenting; 2) present-centered emotional awareness in parenting; 3) non-reactivity/low-reactivity in parenting; and 4) non-judgmental acceptance in parenting. Items are rated on five-point Likert scales (from "never true" to "always true").
Measured: 4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later) end of intervention (8 weeks later) follow-up (8 weeks later)
Parental Stress
The Parenting Stress Index - Short Form (PSI-SF; Abidin, 1995) will be used to assess parental stress. This 36-item self-report measure assesses parental stress over three factors (parental distress, dysfunctional parent-child interactions, and difficult child) and one total stress factor (Abidin, 2012). Items are rated on a 5-point Likert scale (from "strongly agree" to "strongly disagree")
Measured: 4 time-points. Baseline (beginning of study) beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Parental Anxiety
The Generalised Anxiety Disorder Questionnaire (GAD-7; Spitzer, Kroenke \& Williams, 2006) is a 7-item self-report scale to measure generalized anxiety symptoms. Items are rated on a 4-point Likert scale (from "not at all" to "nearly everyday").
Measured: 4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Parental Depression
The Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, \& Willams, 1999) is a 9-item questionnaire assessing symptoms of depression. Items are rated on a 4-point Likert scale (from "not at all" to "nearly everyday")
Measured: 4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
General Stress
The stress subscale of the Depression Anxiety and Stress Scale (DASS-21: Lovibond \& Lovibond, 1995) will be used to assess general stress levels of parents. Items are rated on 4-point Likert scale (from "never" to "almost always").
Measured: 5 time-points. Screening interview (pre-study), baseline (beginning of study, approx. 2-4 weeks later), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Parental quality of life
The Family Dermatology Life Quality Index (FDLQI: Basra, Su-Ho, \& Finlay, 2007) will be used to measure parental quality of life. This self-report measure comprises 10 items assessing a range of ways that a family member's skin condition may impact upon an individual's quality of life, covering two factors (psychosocial impact and physical impact). Items are rated on a 4-point Likert scale (ranging from "not at all" to "very much").
Measured: Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Paediatric quality of life
The Children's Dermatology Life Quality Index (CDLQI: Lewis-Jones \& Finlay, 1995) will be used to assess paediatric quality of life. This self-report measure is completed by the child, and comprises 10-items assessing a range of ways that a child's skin condition may impact upon their quality of life, covering 6 areas (symptoms and feelings, leisure, school or holidays, personal relationships, sleep, treatment). Items are rated on a 4-point Likert scale (ranging from "not at all" to "very much").
Measured: Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Paediatric psoriasis/eczema severity
Children will be asked to indicate the itch intensity of the psoriasis/eczema, on a 10-point scale (from "not at all itchy" to "the worst itchy imaginable")
Measured: 2 time-points. Baseline (beginning of study), follow-up (18 weeks later)
Paediatric psoriasis/eczema itch intensity
Children will be asked to indicate the itch intensity of the psoriasis/eczema, on a 10-point scale (from "not at all bad/severe" to "extremely bad/severe").
Measured: 2 time-points. Baseline (beginning of study), follow-up (18 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start19 Oct 2018
- Primary completion18 Jul 2019
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-group case-series design will be adopted, whereby one group of participants will complete daily and weekly measures over the course of 1) a 2-week baseline period; 2) an 8-week intervention period; 3) an 8-week follow up period. Variables collected during the intervention and follow-up period will be compared with those from the baseline period.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- The Psoriasis and Psoriatic Arthritis Alliance
- Responsible party
- Principal investigator, Andrew Thompson, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873142
- Sponsor's protocol ID
- 249150
- Status last verified
- Sep 2019
- First submitted
- 4 Mar 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abidin, R. R. (1995). Parenting stress index 3rd edition: Professional manual. Psychological Assessment Resources, Inc, Odessa, TX.
Abidin R. R. (2012) Parenting Stress Index. Odessa, FL: Psychological Assessment Resources.
Basra MK, Sue-Ho R, Finlay AY. The Family Dermatology Life Quality Index: measuring the secondary impact of skin disease. Br J Dermatol. 2007 Mar;156(3):528-38. doi: 10.1111/j.1365-2133.2006.07617.x.
PubMed 17300244Bögels, S., & Restifo, K. (2013). Mindful parenting: A guide for mental health practitioners. Springer Science & Business Media.
Duncan, L. G. (2007). Assessment of mindful parenting among parents of early adolescents: Development and validation of the Interpersonal Mindfulness in Parenting scale. The Pennsylvania State University.
Kabat-Zinn, J. (1990). Full catastrophe living. New York: Bantam Doubleday Dell.
Lewis-Jones MS, Finlay AY. The Children's Dermatology Life Quality Index (CDLQI): initial validation and practical use. Br J Dermatol. 1995 Jun;132(6):942-9. doi: 10.1111/j.1365-2133.1995.tb16953.x.
PubMed 7662573Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
PubMed 10568646Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Mindful Parenting Intervention for Parents of Children With Psoriasis and Parents of Children With Eczema: A Single Group Case Series
- ClinicalTrials.gov ID
- NCT03873142
- Acronym / sponsor ID
- 249150
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- The Psoriasis and Psoriatic Arthritis Alliance
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the impact of a mindful parenting intervention on parents of children with psoriasis or eczema. More specifically, this study will investigate the impact of the group on both the child and the parents mental health and quality of life.
Detailed description
Psoriasis and eczema are chronic inflammatory skin conditions that affect up to 2% and 20% of children respectively (Mahe, 2016; Plötz, Wiesender, Todorva \& Ring, 2014). These skin conditions are associated with poorer mental health in the children themselves and in their parents (Megna et al., 2015; Hammer-Helmich et al., 2016). Little research has investigated ways of reducing parental stress in parents of children with chronic health conditions, such as psoriasis and eczema.
"Mindful Parenting" interventions offer one potential way of improving mental health and quality of life in parents and their children. Mindful parenting refers to a parenting style which involves paying close, non-judgemental attention to the child (Duncan et al., 2009). However, no research has investigated the impact of mindful parenting interventions on children with skin conditions and their parents.
The main aim of the current study is to investigate whether a mindful parenting intervention can improve mental health and quality of life in children with psoriasis/eczema and their parents. A single-group case-series design will be adopted, whereby participants will act as their own control; data collected from participants during and after they have received the intervention will be compared to data collected before they have received the intervention. Interviews will also be conducted after the intervention, to explore participants experience of the group.
The investigators predict that the intervention will improve mental health and quality of life in children with psoriasis/eczema and their parents. More specifically, we predict:
- There will be a reduction in negative parental idiosyncratic measures of stress throughout the intervention phase, in comparison to baseline phase, that will be maintained in the follow-up phase.
- There will be an improvement in positive parental idiosyncratic measures of stress during the intervention phase in comparison to baseline phase that will be maintained in the follow-up phase.
- There will be a significant increase in levels of mindful parenting following the intervention phase, in comparison to baseline phase, that will be maintained in the follow-up phase.
- There will be a significant decrease in levels of parental stress at end of intervention phase compared to baseline phase that will be maintained in the follow-up phase.
- There will be a significant increase in parental quality of life and paediatric quality of life at the end of intervention phase compared to baseline phase that will be maintained in the follow-up phase .
- There will be a significant improvement in psoriasis severity and itch at the follow-up phase compared to the baseline phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-group case-series design will be adopted, whereby one group of participants will complete daily and weekly measures over the course of 1) a 2-week baseline period; 2) an 8-week intervention period; 3) an 8-week follow up period. Variables collected during the intervention and follow-up period will be compared with those from the baseline period.
| Arm | Type | Receives |
|---|---|---|
| Mindful parenting intervention | Experimental | Behavioral: Mindful ParentingThere is only one arm in this study. A range of variables will first be measured (daily and weekly) over a baseline period in a group of participants. Following this baseline period, participants will be take part in a mindful parenting intervention whilst the same variables are measured. Following the intervention, there will be an 8-week follow-up period, and mindful parenting groups will not run during this time. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful ParentingThe mindful parenting intervention is an adaption for parents of the Mindfulness-Based Cognitive Therapy (MBCT) for depression (Kabat-Zinn, 1990), and the Mindful-Based Stress Reduction program (MBSR; Kabat-Zinn, 1990). The mindful parenting intervention will follow the manual developed by Bögels and Restifo (2014). The intervention consists of 9x3hour sessions. Eight of these sessions are run on consecutive weeks and the final session is run eight weeks after the eighth session. These groups involve group discussions around parenting, meditation exercises, and yoga, amongst other things. | Behavioural | Mindful parenting intervention |
Primary outcome
Change in parenting stress (idiosyncratic measure)
Time frame: Daily for 20 weeks (baseline-intervention-follow-up)
The primary outcome measures for the proposed study are idiosyncratic measures of stress which will be assessed daily by text message. Participants will be asked to identify one stress-related positive target (something the participant would like to improve) and one negative target (something the participant would like to reduce). Participants will respond to the daily text messages with a score on a 0-100 scale.
10 secondary outcomes
Demographic information
Time frame: 1-time point (baseline period)
Mindful parenting
Time frame: 4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later) end of intervention (8 weeks later) follow-up (8 weeks later)
Parental Stress
Time frame: 4 time-points. Baseline (beginning of study) beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Parental Anxiety
Time frame: 4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Parental Depression
Time frame: 4 time-points. Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
General Stress
Time frame: 5 time-points. Screening interview (pre-study), baseline (beginning of study, approx. 2-4 weeks later), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Parental quality of life
Time frame: Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Paediatric quality of life
Time frame: Baseline (beginning of study), beginning of intervention (2 weeks later), end of intervention (8 weeks later), follow-up (8 weeks later)
Paediatric psoriasis/eczema severity
Time frame: 2 time-points. Baseline (beginning of study), follow-up (18 weeks later)
Paediatric psoriasis/eczema itch intensity
Time frame: 2 time-points. Baseline (beginning of study), follow-up (18 weeks later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- BackgroundAbidin, R. R. (1995). Parenting stress index 3rd edition: Professional manual. Psychological Assessment Resources, Inc, Odessa, TX.
- BackgroundAbidin R. R. (2012) Parenting Stress Index. Odessa, FL: Psychological Assessment Resources.
- Background: PubMed 17300244Basra MK, Sue-Ho R, Finlay AY. The Family Dermatology Life Quality Index: measuring the secondary impact of skin disease. Br J Dermatol. 2007 Mar;156(3):528-38. doi: 10.1111/j.1365-2133.2006.07617.x.
- BackgroundBögels, S., & Restifo, K. (2013). Mindful parenting: A guide for mental health practitioners. Springer Science & Business Media.
- BackgroundDuncan, L. G. (2007). Assessment of mindful parenting among parents of early adolescents: Development and validation of the Interpersonal Mindfulness in Parenting scale. The Pennsylvania State University.
- BackgroundKabat-Zinn, J. (1990). Full catastrophe living. New York: Bantam Doubleday Dell.
- Background: PubMed 7662573Lewis-Jones MS, Finlay AY. The Children's Dermatology Life Quality Index (CDLQI): initial validation and practical use. Br J Dermatol. 1995 Jun;132(6):942-9. doi: 10.1111/j.1365-2133.1995.tb16953.x.
- Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Background: PubMed 10568646Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Parenting in people with Psoriasis and Eczema, run by University of Sheffield at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parenting stress (idiosyncratic measure) (time frame: Daily for 20 weeks (baseline-intervention-follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03873142, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.