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Complicated Grief DisorderNCT06093113

Alba - a Mobile App to Provide Bereavement Support for Adolescents in Grief

A study testing Alba - Youth in grief in people with Complicated Grief Disorder, run by Uppsala University at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this two-armed randomised controlled trial is to evaluate a psychosocial self-management mobile app providing bereavement support to adolescents in grief. The main questions it aims to answer are: 1. How do adolescents in grief interact with and use the app? 2. Read more about this study

Who is it for?
Ages 12 to 19 years
Conditions the study is for
Complicated Grief Disorder
What is being tested?
Alba - Youth in grief
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteSweden
Study dates
10 Dec 2023to 1 Nov 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age 12-19 years old
  • Lost a parent or sibling to any cause of death at least one months ago
  • Comprehend the Swedish language
  • Have access to a mobile/smartphone

Who cannot join

  • Loss occurred less than one month ago

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Uppsala university

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: Development and Evaluation of a Mobile App to Provide Bereavement Support for Adolescents in Grief

The goal of this two-armed randomised controlled trial is to evaluate a psychosocial self-management mobile app providing bereavement support to adolescents in grief. The main questions it aims to answer are:

  1. How do adolescents in grief interact with and use the app?
  2. How do bereaved adolescents perceive the usability of the app?
  3. Is the intervention feasible?
  4. How is the meaningfulness of using the app perceived among adolescents in grief and what effect do the adolescents perceive it to have on their grieving process and everyday life?
  5. Does access to the app affect symptoms of grief, complicated grief, post-traumatic stress and depression among bereaved adolescents?
Read more

Participants will:

  • Test the app (intervention group) or a website containing (control group) psychoeducation for 2 months
  • Fill out online questionnaires regarding their mental health (baseline, post, 6 months, 12 months).
  • Fill out an online questionnaire regarding the acceptability and usability of the app (intervention group)
  • Be asked to participate in narrative interviews (intervention group)

Researchers will compare the intervention group with the control group to see if the app has an effect on bereaved adolescents mental health.

Read the detailed description

The need for professional support is evident in teenagers' grief and approximately half of the bereaved teenagers in Sweden report feeling in need of some type of help or support. Some teenagers in bereavement find it hard to seek help or that seeking help is embarrassing. It could also be hard to recognise if and when they need help, as they might have a low level of knowledge regarding symptoms of grief. Children and teenagers in need of preventive interventions often do not receive the care they need, but effective preventive interventions can support bereaved teenagers to work through their grief adaptively and thus decrease the risk of the negative consequences and complications of loss, such as experiencing complicated grief, depression or post-traumatic stress. This may in turn reduce the need for clinical interventions for psychopathology.

A mobile app could be used as a platform for bereavement support and be a comforting aid available to bereaved teenagers without drawing the attention or knowledge of their peers. Web-based support can lead to younger people seek help at an earlier stage, due to lower stigmatisation. Mobile apps offer additional advantage over face-to-face and web-based interventions because of their availability, accessibility, the immediate support they can provide, and their anonymity (e.g., reducing barriers to seeking help for grief), low costs, and possible tailoring to the user (e.g., the user is in control over when and how to use the app). Therefore, mobile health (mHealth) offers a particularly great and ubiquitous platform for delivering mental health and supportive interventions to teenagers. However, there are few apps for children and teenagers and the benefit of mHealth for children is largely not evaluated. With this background, the research group has using Patient- and Public Involvement worked with 6 bereaved teenagers to develop a psychosocial self-management mobil app for adolescents in grief.

The overall purpose of this project is to evaluate a psychosocial self-management mobile app to provide bereavement support and self-help strategies to adolescents who have lost a parent or a sibling in fatal causes, in a randomised controlled trial. In order to evaluate the acceptability and feasibility of the intervention in bereaved teenagers, the trial will include a pilot phase during which results for recruitment, drop-out randomisation, retention rates and data collection will be used to identify and analyse potential issues with the trial before progression. Data related to the feasibility of the intervention and the accessibility of the app will in addition be collected during the post-assessment and be used to identify needed modifications for the app and the intervention. This data will, along with user-data, be used for evaluation of how bereaved adolescents use and engage with the app. To evaluate the effects of the app on bereaved adolescents mental health symptoms of grief, complicated grief, depression and post-traumatic stress will be measure at baseline, post 2 months of app/website usage, and at 6- and 12 months post randomisation, and compared between the intervention- and control group. Finally, to evaluate the meaningfulness of using the app and the self-perceived effect of the app intervention on bereaved adolescents' grieving process and everyday life, 10-15 participants of the intervention group will be asked to participate in narrative interviews. participants will be recruited using advertisement and in cooperation with non-profit organisations.

Being tested
Alba - Youth in grief, Control website

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alba - Youth in griefBehavioural

    The app will build on principles of cognitive behavioural theory and therapy (CBT) and contains five main sections: Learning, Self-assessment, Manage symptoms, Find support and a Personal space.

  • Control websiteBehavioural

    The website will contain information about grief and grief reactions similar to some of the information given in the app.

Study groups in NCT06093113
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants will complete a web based pre-assessment and then be given access to the app "Alba" for two months followed by a web based post-assessment including questions regarding their experiences of using the app, and follow-up questionnaires.
Receives: Behavioral: Alba - Youth in grief
Control groupActive comparatorParticipants will get access to a website containing information about grief and grief reactions.
Receives: Behavioral: Control website

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change (from baseline) in Traumatic Grief Inventory-Kids-Self report

    16-item, self-rated measure of complicated grief, total score ranges from 16 to 80, where higher score indicates more symptoms

    Measured: 2, 6 and 12 months

Secondary outcomes (3)
  1. Change (from baseline) in Hogan Inventory for Bereavement- Short Form for Children and Adolescents

    21-item, self-rated measure of grief and personal growth, total score ranges from 10 to 50 for the subscale grief with a higher score indicating more symptoms, and a total score of 11 to 55 for the subscale personal growth.

    Measured: 2, 6 and 12 months

  2. Change (from baseline) in Child PTSD Symptom Scale

    27 item, self-rated measure of post-traumatic stress, total score ranges from 0 to 80 for the 20 symptom items, where a higher score indicating more symptoms

    Measured: 2, 6 and 12 months

  3. Change (from baseline) in Patient Health Questionnaire-9

    9 item, self-rated measure of depression, total score ranges from 0 to 27, and a higher score indicates more symptoms

    Measured: 2, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start10 Dec 2023
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention group and active control group.
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06093113
Sponsor's protocol ID
2023-04309-01
Other IDs
2023
Status last verified
Oct 2024
First submitted
3 Oct 2023
Last updated
1 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD

Publications

  • Rhodin R, Eklund R, Silven Hagstrom A, Gjestad R, Dyregrov A, Sveen J. Effects and User-Reported Experiences of a Self-Management Mobile Health App for Grieving Adolescents: Randomized Controlled Trial. J Med Internet Res. 2026 Jul 15;28:e94777. doi: 10.2196/94777.

    PubMed 42459115

Questions about this trial

What is this clinical trial studying?

A study testing Alba - Youth in grief in people with Complicated Grief Disorder, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change (from baseline) in Traumatic Grief Inventory-Kids-Self report (time frame: 2, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06093113, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.

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