PPI and Mindfulness App for Parents of Children With a NDD (Adappt)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Mental Health; Mental Well-being; Ability to Adapt
• Intervention / Treatment: Other: Adappt

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.

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kim Tönis, MSc; Phone Number: +31 53 489 1545; Email: k.j.m.tonis@utwente.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention condition; Participants will use the app for 4 weeks, daily for 10-15 minutes	Other: Adappt; An app to support parents of children with a NDD
Other: Waitlist control condition; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Twente

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: University of Twente

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data (IPD) will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No