PPI and Mindfulness App for Parents of Children with a NDD
- Conditions
- StressMental HealthMental Well-being
- Interventions
- Other: Adappt
- Registration Number
- NCT06248762
- Lead Sponsor
- University of Twente
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 212
- 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.
- presence of severe anxiety symptoms
- presence of moderately severe to severe depressive symptoms
- being in treatment for mental health issues (the parent self)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention condition Adappt Participants will use the app for 4 weeks, daily for 10-15 minutes Waitlist control condition Adappt Participants in the control condition will start using the app 4 months after the start (baseline)
- Primary Outcome Measures
Name Time Method Ability to Adapt 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.
- Secondary Outcome Measures
Name Time Method Anxiety Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline) 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.
Savoring the moment Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline) 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.
Self-reassuring Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline) 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.
Mental well-being Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline) 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.
Depressive symptoms Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline) 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.
Parenting self-efficay and behavior of child Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline) 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).
Postive aspects of caregiving Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline) 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.
Stress Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline) 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.
Psychological flexibility Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline) 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.
Positive coping skills Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline) 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.
Mindfulness Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline) 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.
Trial Locations
- Locations (1)
University of Twente
🇳🇱Enschede, Netherlands