Preliminary evaluation of a structured transition program (Transition) compared with usual support for young adults in Sweden with support in daily living

ISRCTN	ISRCTN13111047
DOI	https://doi.org/10.1186/ISRCTN13111047
Sponsor	Karolinska Institutet
Funder	Forskningsrådet för hälsa, arbetsliv och välfärd

Submission date: 19/02/2026
Registration date: 19/02/2026
Last edited: 20/02/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Contact information

Dr Ulf Jonsson
Public, Scientific, Principal investigator

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
Email	ulf.jonsson@ki.se

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Supportive care
Scientific title	A structured transition program (Transition) compared to usual support for young adults in Sweden with support in daily living: a pilot randomised trial assessing feasibility and initial effects on quality of life and recovery
Study objectives	Young adults in Sweden with disabilities related to mental, behavioural, and neurodevelopmental conditions are increasingly accessing daily living support through social services. This pilot randomised controlled trial evaluates a structured transition program (Transition) as an addition to standard support, compared to standard support alone, for this target group. The aims of the trial are to assess both the feasibility of the program and the evaluation design. Although it is not designed for formal hypothesis testing, the trial will measure and report preliminary effects on quality of life and recovery in comparison to standard support services.
Ethics approval(s)	Approved 03/12/2025, Etikprövningsmyndigheten [The Swedish Ethical Review Authority] (Etikprövningsmyndigheten, Box 2110, Uppsala, SE-750 02, Sweden; +46 (0)10-475 08 00; registrator@etikprovning.se), ref: Dnr 2020-03675, 2021-03796, 2022-02354-02 and 2025-07732-02
Health condition(s) or problem(s) studied	Support for young adults with support needs due to mental, behavioural, and neurodevelopmental conditions.
Intervention	This pilot trial will use a parallel-groups design in which participants are randomly assigned to one of two groups. The allocation ratio is 1:1, and randomisation will occur in blocks of size 10. 1. The randomisation was computer-generated (sealedenvelope.com). Sealed envelopes will be used. One group will receive the Transition program in addition to usual support, while the other group will receive only the usual support. Outcome measures will be collected at the beginning of the trial (baseline) and again at 15 weeks (the endpoint). Additionally, brief interviews will be conducted with participants after 5 weeks and at the endpoint. Participants assigned to the usual support group will be offered the Transition program after completing the initial phase and will then complete the outcome measures again after 15 weeks of working with the program. The Transition program consists of two main components: 1. A standardised education part featuring eight online lectures, each lasting approximately 20 minutes. The first two lectures are mandatory; they provide an overview of the program and introduce the behavioural strategies used, such as goal setting, values, and tiny habits. The remaining lectures focus on essential life skills across key domains, including work, education, finance, housing, health, social participation, and relationships. Participants can choose one or more domains to concentrate on. They can complete the lectures at their own pace, with support from their support worker. 2. Individualised work with the support worker, where participants will formulate and pursue goals based on their values within the selected domain(s), while also establishing small health habits. Support as usual refers to the current practices employed by support workers for this specific target group. This may involve a combination of pedagogical and psychological strategies, such as motivational interviewing, though it is not currently standardised. The specific content of support as usual will be monitored throughout the study.
Intervention type	Behavioural
Primary outcome measure(s)	Feasibility of the evaluation design measured using recruitment rate, intervention uptake, and retention rates at relevant timepoints over the course of the trial Acceptability measured using interviews with all participants at 5 weeks and at endpoint (15 weeks) User satisfaction measured using course evaluations at completion of each section of the program at endpoint Safety measured using a specific question about negative effects at supervison meetings with staff and during the interviews with participants after 5 weeks and at endpoint
Key secondary outcome measure(s)	Health-related quality of life measured using Assessment of Quality of Life (AQoL-8D) at baseline and after 15 weeks (+ after an additional 15 weeks for those in the support as usual group accessing Transition after completion) Recovery measured using Recovery Assessment Scale - Domains and Stages (RAS-DS) at baseline and after 15 weeks (+ after an additional 15 weeks for those in the the support as usual group accessing Transition after completion)
Completion date	30/04/2028

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	29 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Aged 18 to 29 years 2. Currently accessing housing support with planned meetings at a frequency of at least once a week 3. Sufficient proficiency in Swedish
Key exclusion criteria	A diagnosis of intellectual disability.
Date of first enrolment	05/03/2026
Date of final enrolment	30/09/2027

Locations

Countries of recruitment

Sweden

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

20/02/2026: Method of randomisation wording added.
19/02/2026: Study’s existence confirmed by the Swedish Ethical Review Authority.