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

NCT06093113 | Active Not Recruiting

• 1 other identifier: 2023-04309-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Complicated Grief Disorder

Outcome Measures

Primary Outcomes (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

  2, 6 and 12 months

Secondary Outcomes (3)

• Change (from baseline) in Hogan Inventory for Bereavement- Short Form for Children and Adolescents

  2, 6 and 12 months

• Change (from baseline) in Child PTSD Symptom Scale

  2, 6 and 12 months

• Change (from baseline) in Patient Health Questionnaire-9

  2, 6 and 12 months

Other Outcomes (2)

• Feasibility of the intervention and the application

  2 months

• Acceptability of the intervention and the application

  2 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants 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.

Behavioral: Alba - Youth in grief

Control group

ACTIVE COMPARATOR

Participants will get access to a website containing information about grief and grief reactions.

Behavioral: Control website

Interventions

Alba - Youth in grief BEHAVIORAL

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.

Intervention group

Control website BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Loss occurred less than one month ago

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala university

Uppsala, 75185, Sweden

Location

Study Officials

• Josefin Sveen, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group and active control group.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 23, 2023
• Study Start: December 10, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

SE (1)