PPI and Mindfulness App for Parents of Children With a NDD

Stress Clinical Trial

— Adappt  

Official title:

Effectiveness of a Positive Psychology and Mindfulness Based App for Parents of Children With a Neurodevelopmental Disorder (NDD): Study Protocol of a Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06248762
• Other study ID #: University of Twente
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Mental Health
• Mental Well-being
• Stress

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)