PPI and Mindfulness App for Parents of Children with a NDD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adappt.
- Who it may be relevant to
- Registry conditions: Stress, Mental Health, Mental Well-being. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other Adappt
An app to support parents of children with a NDD
Primary outcome measures
- Ability to Adapt [Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]
Secondary outcome measures (11)
- 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)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- presence of severe anxiety symptoms
- presence of moderately severe to severe depressive symptoms
- being in treatment for mental health issues (the parent self)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Netherlands · 1 center
- University of Twente — Enschede
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. PMID 38926739
Identifiers
NCT: NCT06248762 · University of Twente