Leaving Care - a Comparison Study of Implementation, Change Mechanisms, and Effects of Transition Services for Youth Leaving Out-of-home Care

April 1, 2023 updated by: Tina M. Olsson, Jonkoping University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Jönköping, Sweden
        • Recruiting
        • Jonkoping University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Living in out-of-home care
  • 15 years or older

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
This group will receive the test intervention My Choice-My Way!
Behavioral: 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.
Active Comparator: Control
This group will receive usual services
Behavioral: Usual services
Usual services

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Needs Satisfaction and Frustration Scale (NSFS)
Time Frame: 8 months
Autonomy, relatedness, competence
8 months
General Self-Efficacy Scale (GSE-10)
Time Frame: 8 months
Self-efficacy
8 months
Resilience Scale (RS-14)
Time Frame: 8 months
Resilience
8 months
Needs Satisfaction and Frustration Scale (NSFS)
Time Frame: 17 months
Autonomy, relatedness, competence
17 months
General Self-Efficacy Scale (GSE-10)
Time Frame: 17 months
Self-efficacy
17 months
Resilience Scale (RS-14)
Time Frame: 17 months
Resilience
17 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
General Health Questionnaire (GHQ-12)
Time Frame: 8 months
Measure of psychological distress
8 months
General Help-Seeking Questionnaire (GHSQ)
Time Frame: 8 months
Intentions, quantity, and quality of help seeking
8 months
Social Support Questionnaire (SSQ-6)
Time Frame: 8 months
Social Support
8 months
Daily Routines (DR-18)
Time Frame: 8 months
Daily Routine
8 months
General Health Questionnaire (GHQ-12)
Time Frame: 17 months
Measure of psychological distress
17 months
General Help-Seeking Questionnaire (GHSQ)
Time Frame: 17 months
Intentions, quantity, and quality of help seeking
17 months
Social Support Questionnaire (SSQ-6)
Time Frame: 17 months
Social Support
17 months
Daily Routines (DR-18)
Time Frame: 17 months
Daily Routine
17 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (CSQ-8, T2)
Time Frame: 8 months
General satisfaction with services
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jonkoping University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lund University
Göteborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tina M Olsson, PhD, Jonkoping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-01352

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

no plan as of yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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