Self EfficacyNCT05813197
Leaving Care - a Comparison Study of Implementation, Change Mechanisms, and Effects of Transition Services for Youth Leaving Out-of-home Care
A study testing My Choice - My Way! and Usual services in people with Self Efficacy and Mental Health Wellness 1, run by Jonkoping University at 1 site in Sweden.
Trial summary
The purpose of this project is to increase understanding of the development, implementation and effectiveness of interventions for young people transitioning from societal care to independent living. The project examines the effect of interventions and how change mechanisms relate to a range of outcomes. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self Efficacy, Mental Health Wellness 1, Help-Seeking Behavior
- What is being tested?
- My Choice - My Way! and Usual services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- 2 Oct 2022to 31 Dec 2025
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Living in out-of-home care
- 15 years or older
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Jönköping University
Jönköping
Tina M Olsson, PhD, 0046709420371, tina.olsson@ju.se
About this study
The purpose of this project is to increase understanding of the development, implementation and effectiveness of interventions for young people transitioning from societal care to independent living. The project examines the effect of interventions and how change mechanisms relate to a range of outcomes.
Read the detailed description
The purpose of this project is to increase the empirical understanding of the development, implementation and effectiveness of interventions for young people transitioning from societal care to independent living. The project examines the effect of interventions and how change mechanisms relate to a range of outcomes. In a pilot project, the investigators developed an intervention in collaboration with municipal social workers, section heads and organizational developers. In another pilot project, the investigators studied whether the content of empirically tested interventions in the USA can be generalized to a Swedish context. These two projects have resulted in a Swedish intervention: My choice - my way! Previous research shows that young people who are placed in social care are a particularly vulnerable group. Swedish social places little attention to what happens to prepare young people for leaving care. There are currently no interventions in Sweden that have empirical support of their effectiveness for this group. The aim of the project is to develop practical and empirical understanding of how interventions for young people placed in societal care in Sweden can be developed and implemented. The project takes place in close collaboration with municipalities and other youth serving organizations. Short-term, long-term and implementation effects are investigated by comparing My choice - my way! with usual services. The comparisons will shed light on practice components and change mechanisms related to outcomes and thus important to take into account in the future development of interventions. The outcomes will shed light on a range of self-reported outcomes, as well as register-based outcomes such as education, employment and crime. The analyses also include health economic outcomes. In addition, the attitudes of social workers and youth and organizational implementation initiatives will be investigated.
- Conditions
- Self Efficacy, Mental Health Wellness 1, Help-Seeking Behavior, Frustration, Satisfaction, Health Behavior
- Being tested
- My Choice - My Way!, Usual services
- Medical subject headings
- Help-Seeking Behavior, Personal Satisfaction, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Choice - My Way!Behavioural
Support intervention for adolescents (15+) in out-of-home care (foster care, group home care, supported living, institutional care, etc). 16-19 sessions with a MCMW coach, 4-8 months, weekly to bi-weekly sessions.
Usual servicesBehavioural
Usual services
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group will receive the test intervention My Choice-My Way! Receives: Behavioral: My Choice - My Way! |
| Control | Active comparator | This group will receive usual services Receives: Behavioral: Usual services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needs Satisfaction and Frustration Scale (NSFS)
Autonomy, relatedness, competence
Measured: 8 months
General Self-Efficacy Scale (GSE-10)
Self-efficacy
Measured: 8 months
Resilience Scale (RS-14)
Resilience
Measured: 8 months
Needs Satisfaction and Frustration Scale (NSFS)
Autonomy, relatedness, competence
Measured: 17 months
General Self-Efficacy Scale (GSE-10)
Self-efficacy
Measured: 17 months
Resilience Scale (RS-14)
Resilience
Measured: 17 months
Secondary outcomes (8)
General Health Questionnaire (GHQ-12)
Measure of psychological distress
Measured: 8 months
General Help-Seeking Questionnaire (GHSQ)
Intentions, quantity, and quality of help seeking
Measured: 8 months
Social Support Questionnaire (SSQ-6)
Social Support
Measured: 8 months
Daily Routines (DR-18)
Daily Routine
Measured: 8 months
General Health Questionnaire (GHQ-12)
Measure of psychological distress
Measured: 17 months
General Help-Seeking Questionnaire (GHSQ)
Intentions, quantity, and quality of help seeking
Measured: 17 months
Social Support Questionnaire (SSQ-6)
Social Support
Measured: 17 months
Daily Routines (DR-18)
Daily Routine
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start2 Oct 2022
- Primary completion30 Oct 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonkoping University
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Göteborg University
- Responsible party
- Principal investigator, Tina M. Olsson, Jonkoping University
- Investigators
- Tina M Olsson, PhD, Principal investigator, Jonkoping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813197
- Sponsor's protocol ID
- 2021-01352
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no plan as of yet
Publications
Skoog T, Bergstrom M, Karlsson M, Olsson TM. Study protocol for leaving care-A comparison study of implementation, change mechanisms and effectiveness of transition services for youth. PLoS One. 2024 Feb 8;19(2):e0293952. doi: 10.1371/journal.pone.0293952. eCollection 2024.
PubMed 38329996
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leaving Care - a Comparison Study of Implementation, Change Mechanisms, and Effects of Transition Services for Youth Leaving Out-of-home Care
- ClinicalTrials.gov ID
- NCT05813197
- Acronym / sponsor ID
- 2021-01352
- Conditions
- Self Efficacy, Mental Health Wellness 1, Help-Seeking Behavior, Frustration, Satisfaction, Health Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Jonkoping UniversityUniversity, hospital or other
- Collaborators
- Lund University, Göteborg University
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to increase understanding of the development, implementation and effectiveness of interventions for young people transitioning from societal care to independent living. The project examines the effect of interventions and how change mechanisms relate to a range of outcomes.
Detailed description
The purpose of this project is to increase the empirical understanding of the development, implementation and effectiveness of interventions for young people transitioning from societal care to independent living. The project examines the effect of interventions and how change mechanisms relate to a range of outcomes. In a pilot project, the investigators developed an intervention in collaboration with municipal social workers, section heads and organizational developers. In another pilot project, the investigators studied whether the content of empirically tested interventions in the USA can be generalized to a Swedish context. These two projects have resulted in a Swedish intervention: My choice - my way! Previous research shows that young people who are placed in social care are a particularly vulnerable group. Swedish social places little attention to what happens to prepare young people for leaving care. There are currently no interventions in Sweden that have empirical support of their effectiveness for this group. The aim of the project is to develop practical and empirical understanding of how interventions for young people placed in societal care in Sweden can be developed and implemented. The project takes place in close collaboration with municipalities and other youth serving organizations. Short-term, long-term and implementation effects are investigated by comparing My choice - my way! with usual services. The comparisons will shed light on practice components and change mechanisms related to outcomes and thus important to take into account in the future development of interventions. The outcomes will shed light on a range of self-reported outcomes, as well as register-based outcomes such as education, employment and crime. The analyses also include health economic outcomes. In addition, the attitudes of social workers and youth and organizational implementation initiatives will be investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: My Choice - My Way!This group will receive the test intervention My Choice-My Way! |
| Control | Active comparator | Behavioral: Usual servicesThis group will receive usual services |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Living in out-of-home care
- 15 years or older
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Choice - My Way!Support intervention for adolescents (15+) in out-of-home care (foster care, group home care, supported living, institutional care, etc). 16-19 sessions with a MCMW coach, 4-8 months, weekly to bi-weekly sessions. | Behavioural | Intervention |
| Usual servicesUsual services | Behavioural | Control |
Primary outcome
Needs Satisfaction and Frustration Scale (NSFS)
Time frame: 8 months
Autonomy, relatedness, competence
General Self-Efficacy Scale (GSE-10)
Time frame: 8 months
Self-efficacy
Resilience Scale (RS-14)
Time frame: 8 months
Resilience
Needs Satisfaction and Frustration Scale (NSFS)
Time frame: 17 months
Autonomy, relatedness, competence
General Self-Efficacy Scale (GSE-10)
Time frame: 17 months
Self-efficacy
Resilience Scale (RS-14)
Time frame: 17 months
Resilience
8 secondary outcomes
General Health Questionnaire (GHQ-12)
Time frame: 8 months
General Help-Seeking Questionnaire (GHSQ)
Time frame: 8 months
Social Support Questionnaire (SSQ-6)
Time frame: 8 months
Daily Routines (DR-18)
Time frame: 8 months
General Health Questionnaire (GHQ-12)
Time frame: 17 months
General Help-Seeking Questionnaire (GHSQ)
Time frame: 17 months
Social Support Questionnaire (SSQ-6)
Time frame: 17 months
Daily Routines (DR-18)
Time frame: 17 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Derived from this study: PubMed 38329996Skoog T, Bergstrom M, Karlsson M, Olsson TM. Study protocol for leaving care-A comparison study of implementation, change mechanisms and effectiveness of transition services for youth. PLoS One. 2024 Feb 8;19(2):e0293952. doi: 10.1371/journal.pone.0293952. eCollection 2024.
- Individual participant dataSharing planned: Undecided. no plan as of yet
Related trials for Self Efficacy
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
Not yet recruitingPhase 1/2
Reducing Firearm Suicide Among Veterans: Evaluating the Effectiveness of Peer-Delivered Lethal Means Counseling
Suicide, Secure Firearm Storage
Recruiting
Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
Non-suicidal Self-injury (NSSI)
Recruiting
IMB-Guided Health Education Intervention for Medication Adherence and Blood Pressure Control in Non-adherent Hypertensive Patients
Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina M Olsson, PhD principal investigator
Jonkoping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Choice - My Way! and Usual services in people with Self Efficacy and Mental Health Wellness 1, run by Jonkoping 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 2 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 14 Apr 2023. 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?
Contact Tina M Olsson, PhD (0046709420371, tina.olsson@ju.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needs Satisfaction and Frustration Scale (NSFS) (time frame: 8 months). The study lists 6 primary outcomes in all. 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 NCT05813197, 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 14 Apr 2023.