StressAdapptNCT06248762
PPI and Mindfulness App for Parents of Children with a NDD
A study testing Adappt in people with Stress and Mental Health, run by University of Twente at 1 site in Netherlands.
Trial summary
An app based on positive psychology and mindfulness to support the mental well-being of parents of children with a Neurodevelopmental Disorder (NDD) was developed and will be evaluated on effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Mental Health, Mental Well-being
- What is being tested?
- Adappt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Dec 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years
- parent of one or more children (< 18 years) diagnosed with or suspected of a NDD
- having access to internet
- in possession of an e-mail address,
- in possession of a smartphone or tablet
- willing to use the digital intervention for a month, daily for approximately 15 minutes a day.
Who cannot join
- presence of severe anxiety symptoms
- presence of moderately severe to severe depressive symptoms
- being in treatment for mental health issues (the parent self)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ernst Bohlmeijer, Prof. Dr. contact
About this study
Official title: Effectiveness of a Positive Psychology and Mindfulness Based App for Parents of Children with a Neurodevelopmental Disorder (NDD): Study Protocol of a Pragmatic Randomized Controlled Trial
An app based on positive psychology and mindfulness to support the mental well-being of parents of children with a Neurodevelopmental Disorder (NDD) was developed and will be evaluated on effectiveness.
Read the detailed description
This pragmatic randomized controlled trial aims to assess the effectiveness of the Adappt app, an app developed to support the mental well-being of parents of children with a neurodevelopmental disorder (NDD), such as autism and ADHD. This app was developed since research has shown that these parents experience higher stress levels than parents of typically developing children. Furthermore, the app was developed in collaboration with parents of children with a NDD, mental health care professionals and scientists in Europe.
- Conditions
- Stress, Mental Health, Mental Well-being
- Being tested
- Adappt
- Keywords
- ability to adapt, Adappt
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdapptOther
An app to support parents of children with a NDD
| Study group | Role | What they receive |
|---|---|---|
| Intervention condition | Experimental | Participants will use the app for 4 weeks, daily for 10-15 minutes Receives: Other: Adappt |
| Waitlist control condition | Other | Participants in the control condition will start using the app 4 months after the start (baseline) Receives: Other: Adappt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to Adapt
Measured with the10-item Generic Sense of Ability to Adapt Scale (GSAAS). An average score will be calculated ranging from 0 to 4, with higher scores being indicative of higher perceived ability to adapt.
Measured: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary outcomes (11)
Mental well-being
Measured with the 14-item Mental Health Continuum - Short Form (MHC-SF). Averages will be calculated for mental well-being and the subscales emotional, social and psychological well-being, ranging from 0 to 5, with higher scores being indicative for more mental (social, emotional and psychological) well-being.
Measured: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Stress
Measured with the-10 item perceived stress scale (PSS). Sum scores will be calculated ranging from 0 to 40, with higher scores being indicative of larger levels of perceived stress.
Measured: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Anxiety
Measured with the 7-item Hospital Anxiety and Depression Scale (HADS-A). A sum score will be calculated ranging from 0 to 21, with higher scores being indicative of larger anxiety levels.
Measured: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Depressive symptoms
Measured with the 9-item Patient Health Questionnaire (PHQ-9). Sum scores will be calculated ranging from 0 to 27, with higher scores being indicative for larger depressive levels.
Measured: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Parenting self-efficay and behavior of child
Measured with the 24-item Child Adjustment and Parent Efficacy Scale - Developmental Disability (CAPES-DD). A sum score will be calculated for parental self-efficacy, ranging from 16 to 160, with higher scores being indicative of larger parental self-efficacy levels. A sum score will be calculated for the child behavioral subscales: emotional problems (0-4), behavioral problems (0-30), prosocial behavior (0-24) and total problems (0-48).
Measured: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Savoring the moment
Measured with the 8-item savoring the moment subscale of the Savoring Beliefs Inventory (SBI). Sum scores ranging from -24 to +24 will be calculated, with higher scores being indicative of a stronger savoring in the moment.
Measured: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Self-reassuring
Measured with 5-item reassuring-self subscale of the Forms of Criticism/Self-Attacking and Self- Reassuring Scale Short Form (FSCRS-SF). Sum scores ranging from 0 to 20 will be calculated, with higher scores being indicative for a larger sense of self-reassurance.
Measured: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Postive aspects of caregiving
Measured with the 9-item Positive Aspects of Caregiving (PAC). A sum score will be calculated ranging from 9 to 45, with higher scores being indicative of more positive aspects of caregiving.
Measured: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Psychological flexibility
Measured with the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Sum scores will be calculated, ranging from 7 to 49, with higher scores being indicative for larger levels of psychological flexibility.
Measured: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Positive coping skills
Measured with the (16 items of the) subscales Acceptance, Positive refocusing, Positive reappraisal, Putting into perspective of the Cognitive Emotion Regulation Questionnaire (CERQ). Sum scores ranging from 4 to 20 will be calculated for each subscale, with higher scores being indicative of larger cognitive strategy use frequency.
Measured: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Mindfulness
Measured with the 15-item Mindfulness Attention Awareness Scale (MAAS). Mean scores will be calculated ranging from 1 to 6, with higher scores being indicative of more mindfulness.
Measured: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start3 Dec 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Delayed waitlist control
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Tonis, University of Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248762
- Sponsor's protocol ID
- University of Twente
- Acronym
- Adappt
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared
Publications
Tonis KJM, Drossaert CHC, Ten Klooster PM, Schaer M, Bourgeron T, Buitelaar JK, Sadaka Y, Freitag CM, Lapidus KM, Chiocchetti AG, Staal WG, Bohlmeijer ET. Effectiveness of a positive psychology and mindfulness-based app on mental health for parents of children with a neurodevelopmental disorder: study protocol of a pragmatic international randomized controlled trial. Trials. 2024 Jun 26;25(1):412. doi: 10.1186/s13063-024-08256-w.
PubMed 38926739
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Positive Psychology and Mindfulness Based App for Parents of Children with a Neurodevelopmental Disorder (NDD): Study Protocol of a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06248762
- Acronym / sponsor ID
- Adappt / University of Twente
- Conditions
- Stress, Mental Health, Mental Well-being
- Keywords
- ability to adapt, Adappt
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- University of TwenteUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 8 Feb 2024 (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.
An app based on positive psychology and mindfulness to support the mental well-being of parents of children with a Neurodevelopmental Disorder (NDD) was developed and will be evaluated on effectiveness.
Detailed description
This pragmatic randomized controlled trial aims to assess the effectiveness of the Adappt app, an app developed to support the mental well-being of parents of children with a neurodevelopmental disorder (NDD), such as autism and ADHD. This app was developed since research has shown that these parents experience higher stress levels than parents of typically developing children. Furthermore, the app was developed in collaboration with parents of children with a NDD, mental health care professionals and scientists in Europe.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Delayed waitlist control
| Arm | Type | Receives |
|---|---|---|
| Intervention condition | Experimental | Other: AdapptParticipants will use the app for 4 weeks, daily for 10-15 minutes |
| Waitlist control condition | Other | Other: AdapptParticipants in the control condition will start using the app 4 months after the start (baseline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least 18 years
- parent of one or more children (< 18 years) diagnosed with or suspected of a NDD
- having access to internet
- in possession of an e-mail address,
- in possession of a smartphone or tablet
Key exclusion criteria (3 listed)
- presence of severe anxiety symptoms
- presence of moderately severe to severe depressive symptoms
- being in treatment for mental health issues (the parent self)
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 |
|---|---|---|
| AdapptAn app to support parents of children with a NDD | Other | Intervention condition, Waitlist control condition |
Primary outcome
Ability to Adapt
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Measured with the10-item Generic Sense of Ability to Adapt Scale (GSAAS). An average score will be calculated ranging from 0 to 4, with higher scores being indicative of higher perceived ability to adapt.
11 secondary outcomes
Mental well-being
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Stress
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Anxiety
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Depressive symptoms
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Parenting self-efficay and behavior of child
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Savoring the moment
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Self-reassuring
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Postive aspects of caregiving
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Psychological flexibility
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Positive coping skills
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Mindfulness
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Derived from this study: PubMed 38926739Tonis KJM, Drossaert CHC, Ten Klooster PM, Schaer M, Bourgeron T, Buitelaar JK, Sadaka Y, Freitag CM, Lapidus KM, Chiocchetti AG, Staal WG, Bohlmeijer ET. Effectiveness of a positive psychology and mindfulness-based app on mental health for parents of children with a neurodevelopmental disorder: study protocol of a pragmatic international randomized controlled trial. Trials. 2024 Jun 26;25(1):412. doi: 10.1186/s13063-024-08256-w.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared
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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.
Ernst Bohlmeijer, Prof. Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adappt in people with Stress and Mental Health, run by University of Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim Tönis, MSc (+31 53 489 1545, k.j.m.tonis@utwente.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to Adapt (time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)). 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 NCT06248762, which also lists 1 linked publication.
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 21 Feb 2025.