PPI and Mindfulness App for Parents of Children with a NDD

NCT ID: NCT06248762

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-03

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Stress Mental Health Mental Well-being

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Delayed waitlist control
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention condition

Participants will use the app for 4 weeks, daily for 10-15 minutes

Group Type EXPERIMENTAL

Adappt

Intervention Type OTHER

An app to support parents of children with a NDD

Waitlist control condition

Participants in the control condition will start using the app 4 months after the start (baseline)

Group Type OTHER

Adappt

Intervention Type OTHER

An app to support parents of children with a NDD

Interventions

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Adappt

An app to support parents of children with a NDD

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Twente

OTHER

Sponsor Role lead

Responsible Party

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Kim Tonis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Twente

Enschede, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Kim Tönis, MSc

Role: CONTACT

+31 53 489 1545

Ernst Bohlmeijer, Prof. Dr.

Role: CONTACT

References

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Tonis KJM, Drossaert CHC, Ten Klooster PM, Schaer M, Bourgeron T, Buitelaar JK, Sadaka Y, Freitag CM, Lapidus KM, Chiocchetti AG, Staal WG, Bohlmeijer ET. Effectiveness of a positive psychology and mindfulness-based app on mental health for parents of children with a neurodevelopmental disorder: study protocol of a pragmatic international randomized controlled trial. Trials. 2024 Jun 26;25(1):412. doi: 10.1186/s13063-024-08256-w.

Reference Type DERIVED
PMID: 38926739 (View on PubMed)

Other Identifiers

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University of Twente

Identifier Type: -

Identifier Source: org_study_id

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