Mental Health, Mental Well-being, Stress
Conditions
Keywords
ability to adapt, Adappt
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.
Interventions
OTHERAdappt
An app to support parents of children with a NDD
Sponsors
University of Twente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Delayed waitlist control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with the app | 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. | 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. |
Countries
Netherlands
Contacts
Primary ContactKim Tönis, MSc
Backup ContactErnst Bohlmeijer, Prof. Dr.
Outcome results
None listed