Clinical trial NCT06248762: PPI and Mindfulness App for Parents of Children with a NDD
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Mental Health
Mental Well-being
Keywords: ability to adapt
Adappt
Lead sponsor: University of Twente
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Delayed waitlist control
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. at least 18 years
2. parent of one or more children (\< 18 years) diagnosed with or suspected of a NDD
3. having access to internet
4. in possession of an e-mail address,
5. in possession of a smartphone or tablet
6. willing to use the digital intervention for a month, daily for approximately 15 minutes a day.

Exclusion Criteria:

1. presence of severe anxiety symptoms
2. presence of moderately severe to severe depressive symptoms
3. being in treatment for mental health issues (the parent self)

Primary outcomes:
measure: Ability to Adapt
timeFrame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary outcomes:
measure: Mental well-being
timeFrame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
measure: Stress
timeFrame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
measure: Anxiety
timeFrame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
measure: Depressive symptoms
timeFrame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
measure: Parenting self-efficay and behavior of child
timeFrame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
measure: Savoring the moment
timeFrame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
measure: Self-reassuring
timeFrame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
measure: Postive aspects of caregiving
timeFrame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
measure: Psychological flexibility
timeFrame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
measure: Positive coping skills
timeFrame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
measure: Mindfulness
timeFrame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Other outcomes:
measure: Satisfaction with the app
timeFrame: Satisfaction with the app will be measured post intervention. This is 1 month post baseline for the intervention condition participants and at the second follow-up (7 months after baseline) for the control condition participants.
Locations:
city: Enschede
country: Netherlands
facility: University of Twente
Study officials:
References: