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NCT Number: NCT06248762

PPI and Mindfulness App for Parents of Children with a NDD

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.

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Key information

Conditions

Stress Behavior Mental Health Mental Well-being Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Twente

Enschede, Netherlands

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Adappt

Other

An app to support parents of children with a NDD

Primary outcomes

  1. Ability to Adapt

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

    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.

Secondary outcomes

  1. Mental well-being

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

    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.

  2. Stress

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

    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.

  3. Anxiety

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

    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.

  4. Depressive symptoms

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

    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.

  5. Parenting self-efficay and behavior of child

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

    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).

  6. Savoring the moment

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

    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.

  7. Self-reassuring

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

    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.

  8. Postive aspects of caregiving

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

    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.

  9. Psychological flexibility

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

    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.

  10. Positive coping skills

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

    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.

  11. Mindfulness

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

    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.

Other outcomes

  1. Satisfaction with the app

    Time frame: 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ernst Bohlmeijer, Prof. Dr.

CONTACT

[email protected]

Kim Tönis, MSc

CONTACT

[email protected]

+31 53 489 1545

Sponsors and collaborators

Lead sponsor

University of Twente

Other

Registry information

Official study 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

Acronym: Adappt

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2024
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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