An interventional study of Adappt in Stress, Mental Health and Mental Well-being, sponsored by University of Twente. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by University of Twente · Not applicable, Interventional, and Supportive care
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.
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.
University of Twente is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will use the app for 4 weeks, daily for 10-15 minutes
Other: Adappt
Participants in the control condition will start using the app 4 months after the start (baseline)
Other: Adappt
An app to support parents of children with a NDD
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)
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)
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)
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)
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)
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
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.
Plan to share: No — Individual Participant Data (IPD) will not be shared
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University of Twente