Preliminary evaluation of a structured support program for young people not in education, employment, or training
| ISRCTN | ISRCTN23352772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23352772 |
- Submission date
- 08/10/2021
- Registration date
- 08/10/2021
- Last edited
- 28/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
School absenteeism and drop-out is a major societal challenge. Young people not in education, employment, or training are at risk for a range of adverse social and health-related long-term outcomes. Effective strategies to support this group to resume their education is therefore of high priority. In Sweden, the municipalities have an obligation to provide support and guidance to help young people complete upper-secondary school. However, current practice differs between municipalities and the support provision has not been systematically evaluated.
The Transition program was originally developed as a structured support program for young adults with autism spectrum disorder or ADHD. The program combines a series of lectures covering seven important life domains, with individual support to help the participants identify values and goals within these domains and to start taking small steps in the valued direction. Preliminary results indicate that the program is well received by young adults and staff and can lead to positive change. This study aims to examine if the Transition program can be helpful also for young people who have not yet completed upper-secondary school and are currently not in education, employment, or training.
Who can participate?
People who are 16 to 20 years of age, have not completed upper-secondary school, and are currently not in education, employment, or training.
What does the study involve?
Participants will be randomly allocated into one of two groups: The Transition program as an add-on to the support currently provided by the municipality, or a control group receiving only the usual support. The Transition program consists of a series of online lectures and individual support for a total of 15 weeks. Participants will rate their quality of life, self-efficacy, health, and functioning before and after the intervention, and 6 months after completion.
What are the possible benefits and risks of participating?
The Transition program can provide participants with structured support to resume their education and prepare for adulthood in general. All specific components of the Transition program have been derived from well-established approaches previously tested for this age group, including cognitive behavioural interventions and psychoeducation. The program has also been tested with good results in a different target group. As with other interventions, it is unlikely that all participants will benefit from the Transition program. Some transient emotional distress might also be expected as a consequence of new insights and changes in daily living during the program. Negative effects will be closely monitored throughout the study.
Where is the study run from?
Karolinska Institutet (Sweden)
When is the study starting and how long is it expected to run for?
September 2020 to June 2024
Who is funding the study?
FORTE: Swedish Research Council for Health, Working Life and Welfare (Sweden)
Who is the main contact?
Dr Ulf Jonsson
ulf.jonsson@ki.se
Contact information
Scientific
Karolinska Institutet
Center of Neurodevelopmental Disorders at Karolinska Institutet (KIND)
Gävlegatan 22B
Stockholm
SE-113 30
Sweden
 ORCID ID |
0000-0002-5761-2943 |
|---|---|
| Phone | +46 (0)73 806 43 37 |
| ulf.jonsson@ki.se |
Public
Karolinska Institutet
Center of Neurodevelopmental Disorders at Karolinska Institutet (KIND)
Gävlegatan 22B
Stockholm
SE-113 30
Sweden
| Phone | +46 (0)73 806 43 37 |
|---|---|
| ulf.jonsson@ki.se |
Study information
| Study design | Parallel open-label pilot randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Feasibility, acceptability, and preliminary efficacy of the Transition program for young people not in education, employment, or training: a pilot randomized controlled trial with a support as usual comparator |
| Study objectives | The aim of this pilot randomized controlled trial is to assess the feasibility, acceptability, and preliminary efficacy of the Transition program for young people not in education, employment, or training. The pilot trial will not be powered for formal hypothesis testing. However, preliminary effects on quality of life, self-efficacy, mental health, and functioning compared with support as usual will be evaluated. |
| Ethics approval(s) | Approved 07/09/2020 and 12/07/2021, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, SE-750 02 Uppsala, Sweden; +46 (0)10 4750800; registrator@etikprovning.se), ref: dnr 2020-03675 and dnr 2021-03796 |
| Health condition(s) or problem(s) studied | Quality of life, mental health, self-efficacy and functioning in young people not in education, employment, or training |
| Intervention | This pilot trial will employ a parallel-groups design, where participants will be randomly assigned (1:1 allocation rate) by permuted block randomisation to either the Transition program as an add-on to support as usual, or support as usual only. Outcome measures will be collected at baseline, at 15 weeks (post-intervention), and 6 months after completion. The Transition program consists of two key components: 1. A standardised education program covering information and life skills within seven significant life domains (i.e., work, education, finance, housing, health, participation in society, and relationships) 2. An individualised support program in which values and concrete goals within these life domains are formulated and pursued. The educational part consists of seven online lectures (approximately 20 minutes each), which the participants can complete at their own pace together with their support worker. However, a minimum of one lecture per week is recommended. Each lecture is followed by questions designed to help the participant consider their own situation. The individualised part will initially run in parallel with the lectures and continue for up to 15 weeks. In conjunction with each lecture, the participants will reflect on their values within each domain and start formulating long-term goals aligned with these values. Each goal will be subdivided into concrete activities using Goal Attainment Scaling. With weekly assistance from the support worker, the participants will thereafter start working on concrete change guided by their values, goals, and activities. Support as usual is defined as the current practice used by support workers for this specific target group. This can include a combination of pedagogical and psychological strategies (e.g., motivational interviewing), but is currently not standardised. The specific content of support as usual will be monitored throughout the study. |
| Intervention type | Behavioural |
| Primary outcome measure | Feasibility/acceptability: 1. Recruitment rate, intervention uptake, and retention is measured using information collected continuously over the course of the trial 2. Characteristics of the included and retained samples (e.g., diagnoses, age, gender, years of schooling) collected at baseline 3. Participant satisfaction and relevance measured using course evaluations after each of the 8 sessions and post-intervention 4. Participation/involvement measured using the Patient Participation and Rehabilitation Questionnaire post-intervention 5. Negative effects measured using the Negative Effects Questionnaire post-intervention, one free text question included in the course evaluations administered after each session and post-intervention, and spontaneously reported events 5. Feasibility/acceptability overall based on in-depth interviews with participants and staff mid-intervention and post-intervention |
| Secondary outcome measures | Current secondary outcome measures as of 29/10/2021: Preliminary efficacy: 1. Quality of life measured using Assessment of Quality of Life (AQoL-8D) and EQ-5D-5L at baseline, post-intervention, and 6 months after completion 2. Mental health measured using the General Health Questionnaire (GHQ-12) at baseline, post-intervention, and 6 months after completion 3. Self-efficacy measured using the Generalized Self-Efficacy Scale at baseline, post-intervention, and 6 months after completion 4. Functioning measured using the Social and Self-Direction subscales of the Adaptive Behavior Assessment System (ABAS) at baseline, post-intervention, and 6 months after completion 5. Knowledge within the life domains covered by the Transition program measured using a knowledge test developed for this purpose at post-intervention Previous secondary outcome measures: Preliminary efficacy: 1. Quality of life measured using Assessment of Quality of Life (AQoL-8D) and EQ-5D-5L at baseline, post-intervention, and 6 months after completion 2. Mental health measured using the General Health Questionnaire (GHQ-12) at baseline, post-intervention, and 6 months after completion 3. Self-efficacy measured using the Generalized Self-Efficacy Scale at baseline, post-intervention, and 6 months after completion 4. Functioning measured using Adaptive Behavior Assessment System (ABAS) at baseline, post-intervention, and 6 months after completion 5. Knowledge within the life domains covered by the Transition program measured using a knowledge test developed for this purpose at post-intervention |
| Overall study start date | 07/09/2020 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 20 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 36 |
| Key inclusion criteria | Current participant inclusion criteria as of 29/10/2021: 1. Aged 16 to 20 years 2. Have not completed upper-secondary school and currently not enrolled in education or training 3. Sufficient proficiency in Swedish Previous participant inclusion criteria: 1. Aged 16 to 20 years 2. Have not completed upper-secondary school and currently not enrolled in education or training |
| Key exclusion criteria | 1. Intellectual disability 2. Currently preparing actively for enrolment in education |
| Date of first enrolment | 08/11/2021 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Gävlegatan 22B
Stockholm
SE-113 30
Sweden
Sponsor information
University/education
Karolinska Institutet
Stockholm
SE-171 77
Sweden
| Phone | +46 (0)8 524 865 95 |
|---|---|
| registrator@ki.se | |
| Website | http://ki.se/en/startpage |
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
Research council
Government organisation / Local government
- Alternative name(s)
- Swedish Research Council for Health, Working Life and Welfare, FORTE
- Location
- Sweden
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Planned publication in a peer-reviewed open access journal 2. Dissemination of findings to Swedish municipalities and other stakeholders 3. No additional documents are available for this pilot trial |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
28/06/2024: The intention to publish date was changed from 31/12/2024 to 30/06/2025.
28/06/2023: The following changes have been made:
1. The overall study end date was changed from 31/01/2024 to 30/06/2024 and the plain English summary was updated to reflect that change.
2. The study website was added.
3. The total final enrolment was added.
4. The intention to publish date was changed from 30/06/2024 to 31/12/2024.
28/09/2022: The recruitment end date was changed from 30/09/2022 to 30/06/2023.
29/10/2021: The following changes have been made:
1. The secondary outcome measures have been updated.
2. The participant inclusion criteria have been updated.
