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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06248762
Other study ID # University of Twente
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2024
Est. completion date August 2025

Study information

Verified date February 2024
Source University of Twente
Contact Kim Tönis, MSc
Phone +31 53 489 1545
Email k.j.m.tonis@utwente.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 212
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Adappt
An app to support parents of children with a NDD

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Twente

Outcome

Type Measure Description Time frame Safety issue
Other 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. Satisfaction with the app will be measured post intervention (1 month post baseline) for the intervention condition participants and at the second follow-up (7 months after baseline) for the control condition participants.
Primary 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. Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary 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. Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary 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. Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary 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. Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary 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. Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary 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). Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary 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. Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary 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. Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary 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. Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary 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. Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary 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. Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Secondary 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. Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
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