NCT02316158

Brief Summary

The overall aim with the project PsYoungSupport is to evaluate Internet and communication technology (ICT) health efforts, i.e. information, education and support for young adults (16-25 years) who are first degree relatives or represent the close social network (relative or close friend) of individuals with mental illness, with regard to the process (the quality and usefulness of the support) and the effect (on health and quality of life, situation as relative or part of close social network and consumption of other support/care) of the intervention. The participatory design is one of the foundations of this project, and young adult participants will be consulted through out the research project. PsYoungSupport is a research program comprising three phases, Phase I is a survey of young relatives' and close friends' needs for internet based information, education and support, Phase II is the development of a website, and Phase III is an intervention based on the previous phases. The aim of phase III is to evaluate the effect of an internet based intervention containing information, education and support for young adults in families where a family member suffers from mental illness or functional disability. The participants (N=400) will be randomised to two groups with different kinds of support. The participants will be evaluated using self-questionnaires and web interviews at the following occasions: baseline at the start of the intervention, after 4 months and after 8 months. This project will have implications for persons suffering from mental illness as well as for their relatives and close friends.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2011

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
Last Updated

December 12, 2014

Status Verified

September 1, 2011

Enrollment Period

3 months

First QC Date

September 2, 2011

Last Update Submit

December 9, 2014

Conditions

Mental IllnessWeb

Keywords

BurdenMental illnessStressSocial support

Outcome Measures

Primary Outcomes (1)

  • Decreased change in Burden

    Cope Index (McKee, Philp, Lamura et al 2003. The Cope Index measures components such as negative effect of caring, positive values and the quality of support aspects of supporting a relative or close friend. Each question is answered on a 4-point scale with the alternative 'never' ,'sometimes', 'often' and 'always'. Some questions have the alternative of 'not applicable'. All scores are added within each area and high scores indicate a high level of negative effect, positive value and quality of support.

    8 months

Secondary Outcomes (1)

  • Decreased Stress

    Eight months

Study Arms (2)

Webb-based support and education

EXPERIMENTAL

It contains of two parts 1) evidence based information (about mental diseases, early signs, coping strategies, what you can do for your relative or close friend, what you can do for yourself, addresses to networks and web sites, relevant juridical issues, etc), 2) FAQ, where you directly can find answers to common questions.

Other: Web-based support

Available support in society

ACTIVE COMPARATOR

Available support in society for young persons presented in a brochure

Other: Web-based support

Interventions

Web-based supportOTHER

Comparison between the efficacy between webb-based support and informational support

Also known as: website: www.molnhopp.nu
Available support in societyWebb-based support and education

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 16-25 years
  • seeing themselves as a relative or close friend who supports a person with mental illness

You may not qualify if:

  • persons who do not understand, read or express him-/herself in Swedish
  • persons with acute severe mental illness or acute suicidal risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vårdalinstitutet - The Swedish Institute for Health Sciences

Gothenburg, 405 30, Sweden

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Ingela Skärsäter, PhD

    University of Gothenburg, 405 30 Göteborg, Sweden

    PRINCIPAL INVESTIGATOR

  • Barbro Krevers, PhD

    Linköping University, 581 83 Linköping, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2011

First Posted

December 12, 2014

Study Start

March 1, 2009

Primary Completion

June 1, 2009

Study Completion

May 1, 2010

Last Updated

December 12, 2014

Record last verified: 2011-09

Locations

SE(1)