PPI and Mindfulness App for Parents of Children with a NDD

NCT06248762 | Recruiting

• 1 other identifier: University of Twente
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Mental Health; Mental Well-being

Keywords

ability to adapt; Adappt

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Mental well-being

  Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)

• Stress

  Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)

• Anxiety

  Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)

• Depressive symptoms

  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

  Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)

Other Outcomes (1)

• 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.

Study Arms (2)

Intervention condition

EXPERIMENTAL

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

Other: Adappt

Waitlist control condition

OTHER

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

Other: Adappt

Interventions

Adappt OTHER

An app to support parents of children with a NDD

Intervention condition; Waitlist control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years
• parent of one or more children (\< 18 years) diagnosed with or suspected of a NDD
• having access to internet
• in possession of an e-mail address,
• in possession of a smartphone or tablet
• willing to use the digital intervention for a month, daily for approximately 15 minutes a day.

You may not qualify if:

• presence of severe anxiety symptoms
• presence of moderately severe to severe depressive symptoms
• being in treatment for mental health issues (the parent self)

Sponsors & Collaborators

• University of Twente: lead

Study Sites (1)

University of Twente

Enschede, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 38926739 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Kim Tönis, MSc

CONTACT

+31 53 489 1545; k.j.m.tonis@utwente.nl

Ernst Bohlmeijer, Prof. Dr.

CONTACT

e.t.bohlmeijer@utwente.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Delayed waitlist control

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 8, 2024
• Study Start: December 3, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)