PPI and Mindfulness App for Parents of Children with a NDD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Twente
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
presence of severe anxiety symptoms
presence of moderately severe to severe depressive symptoms
being in treatment for mental health issues (the parent self)
Trial design
Design model
Parallel
Treatments tested in this trial
Adappt
Other interventionAn app to support parents of children with a NDD
Treatment groups
212 Participants
are divided into 2 treatment groupsGroup A: Intervention conditionExperimental treatment 1 intervention
Group B: Waitlist control conditionOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)Secondary outcomes
1
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.
Time frame
Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)2
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.
Time frame
Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)3
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.
Time frame
Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)4
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.
Time frame
Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)Other outcomes
1
Satisfaction with the app
Measured with the 8-item Client Satisfaction Questionnaire (CSQ-8). A sum score will be calculated ranging from 8 to 32, with higher scores being indicative of a larger satisfaction with the Adappt app.
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov