Condition category
Not Applicable
Date applied
27/08/2018
Date assigned
06/11/2018
Last edited
06/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The proportion of young people not in education, employment or training (NEET) below 30 years of age has stagnated, despite the economic recovery. Among the 25-29-year-olds, 7-8 % are NEET and have been so for a minimum of two years, costing DKK 105 billion in expenses and lost income for Danish society. There is a need for knowledge about what employment interventions can help young people into education and a job. A large percentage of young people NEET have poor well-being and studies shows that the frequency of smoking, physical inactivity and stress is high. Currently, many municipalities are using physical activity as an element in their employment interventions, but the offers vary and are not scientifically tested. The aim of this study is to generate evidence for what works in employment interventions among young Danes and to test physical activity as a tool on the path to education and a job among young people aged 18-30 years not in employment, education or training (NEET).

Who can participate?
Young people aged 18-30 not in employment, education or training (NEET)

What does the study involve?
Participants are randomly allocated to either take part in intervention 1 (NEXT STEP physical activity) or intervention 2 (NEXT STEP learning and society) or the control group (following usual practice and employment interventions). Both interventions last a total of 16 weeks, and the young people are included in a group of 10-15 participants. Fixed boundaries are established and the group meets for a total of 11 hours a week: 5.5 hours twice a week during daytime hours. Both courses include breakfast and lunch. NEXT STEP physical activity includes six hours of weekly physical activity, consisting of a combination of green exercise and team sports, visits to the local sports associations and workshops on handling daily challenges as well as on future and skills. NEXT STEP learning and society includes elements from a job-oriented employment intervention in a more standard format with e.g. education and company visits, preparation of education plans, but also creative elements for development of professional and social skills. The course gradually builds up towards internships, possibly with a mentoring scheme. The intervention is based on knowledge of similar ongoing employment interventions taking place in the job centres’ youth units, but it also contains elements of creative development. Questionnaires and measurements are conducted before the intervention, just after, and 12 and 24 months after the end of the intervention.

What are the possible benefits and risks of participating?
Participants may benefit from increasing their chances of starting education or getting a job. Moreover, they benefit by improving their health and their scene of community. There is a risk of smaller injuries related to the physical training.

Where is the study run from?
This study is being run by the National Institute of Public Health University of Southern Denmark (Denmark) and takes place in schools in Denmark.

When is the study starting and how long is it expected to run for?
August 2017 to December 2019

Who is funding the study?
Helsefonden Denmark; Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis’ Legat; Østifterne and TrygFonden (Denmark)

Who is the main contact?
Dr Teresa Holmberg
tho@niph.dk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Teresa Holmberg

ORCID ID

Contact details

Studiestræde 6
Copenhagen
1455
Denmark
+45 (0)65507814
t.holmberg11@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

012018

Study information

Scientific title

NEXT STEP - a pilot test of a three-armed randomized controlled trial evaluating employment interventions among Danish young people not in education, employment or training (NEET)

Acronym

Study hypothesis

The primary hypotheses is that an employment intervention (NEXT STEP physical activity) with a focus on physical activity will:
1. Improve physical and mental health among young people not in education, employment or training (NEET)
2. Increase the proportion that starts an education or gets a job
compared to a control group following the municipalities normal practice and employment interventions.

The primary aim of NEXT STEP is to generate the scientific evidence for what works in employment interventions among young Danes and to test physical activity as a tool on the path to education and job among young people aged 18-30 years not in employment, education or training (NEET).

Ethics approval

1. Danish Ethical Committee, ref: H-18026549 - approval pending
2. Danish Data Protection Agency, ref: 100464

Study design

Pilot test of a three-armed randomized controlled design and associated field study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contacts to request a participant information sheet

Condition

Education and job, physical and mental health

Intervention

This is the pilot test with subsequent evaluation and adaptation before the intervention is up-scaled and evaluated from august 2019. NEXT STEP is pilot-tested in Slagelse Municipality over two phases from September 2018 and one year onwards

Via job consultants in the youth units in the municipalities young people NEET will be recruited for inclusion in NEXT STEP. The job consultants will randomise the participants to either intervention 1 (NEXT STEP physical activity) or intervention 2 (NEXT STEP learning and society) or the control group (following usual practice and employment interventions).

A comprehensive course manual with daily programmes described in detail will be prepared for both NEXT STEP physical activity and NEXT STEP learning and society. Both courses last a total of 16 weeks, and the young people NEET will be included in a group of 10-15 participants. Fixed boundaries will be established and the group will meet a total of 11 hours a week: 5.5 hours twice a week during daytime hours. Both courses include breakfast and lunch. The interventions will be managed by a municipally employed instructor from e.g. the health department, the rehabilitation unit or the youth unit in the job centre. The participating municipalities will decide themselves who will be responsible, although it is a recommended that the instructor has knowledge about the target group and experiences with physical activity. NEXT STEP physical activity and NEXT STEP learning and society also include a number of other elements that is presented in the following sections.

NEXT STEP physical activity
NEXT STEP physical activity is structured around: Fixed boundaries, Body and physical activity, Relation/community promoting elements and Workshops on future and skills. The course includes six hours of weekly physical activity, consisting of a combination of green exercise and team sports. Visits to the local sports associations and workshops on handling daily challenges as well as on future and skills. 1-3 volunteers will assist the instructor.

NEXT STEP learning and society
NEXT STEP learning and society is structured around: Fixed boundaries, Learning, society and culture, Relation/community-promoting elements and Workshops on future and skills. The course includes elements from a job-oriented employment intervention in a more standard format with e.g. education and company visits, preparation of education plans, but also creative elements for development of professional and social skills. The course gradually builds up towards internships, possibly with a mentoring scheme. The intervention is based on knowledge of similar ongoing employment interventions taking place in the job centres’ youth units, but it also contains elements of creative development.

The components of the intervention, which will be further developed in cooperation with employees from the youth unit in Slagelse Municipality during the pilot test from September 2018 to August 2019

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Self-rated health measured using 5-item self-rated health scale and SF-12 questionnaire at baseline, 4 and 16 months

Secondary outcome measures

1. Proportion in education or job, measured using a questionnaire and register data at baseline, 4, 16 and 28 months
2. Proportion who are education-ready or able to work, measured using a questionnaire based on questions from the Danish BeskæftigelsesIndikatorProjektet (Væksthusets Forskningscenter 2017) at baseline, 4, 16 and 28 months
3. Physical form, assessed using questionnaire and objective measurements at baseline, 4 and 16 months
4. Physical activity level, assessed using a questionnaire at baseline, 4 and 16 months
5. Mental well-being, assessed using PHQ-4, Rosenberg Self-Esteem Scale (RSES), WHO-5, Three-Item Loneliness Scale (T-ILS), SF-12 at baseline, 4 and 16 months
6. Social support and network, assessed using questionnaire based on questions from the Danish BeskæftigelsesIndikatorProjektet (Væksthusets Forskningscenter 2017) at baseline, 4 and 16 months
7. Self-efficacy (belief in own abilities), assessed using questionnaire inspired by Schwarzer & Jerusalems (1995) scale for general self-efficacy and on questions from the Danish BeskæftigelsesIndikatorProjektet (Væksthusets Forskningscenter 2017) at baseline, 4 and 16 months
8. Social skills, assessed using a questionnaire at baseline, 4 and 16 months
9. Clarification in relation to education or work, assessed using a questionnaire based on questions from the Danish BeskæftigelsesIndikatorProjektet (Væksthusets Forskningscenter 2017) at baseline, 4 and 16 months

Overall trial start date

01/08/2017

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Young people not in education, employment or training (NEET) aged between 18 and 30 years. For people without a diploma from primary school or a completed vocational or higher education programme, the goal is education.

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

75

Participant exclusion criteria

1. People with serious illnesses implying that physical activity is not recommended
2. People not able to participate in a group-based course of physical activity for health or behavioral reasons

Recruitment start date

28/08/2018

Recruitment end date

01/06/2019

Locations

Countries of recruitment

Denmark

Trial participating centre

National Institute of Public Health, University of Southern Denmark
Studiestræde 6
Copenhagen
1455
Denmark

Sponsor information

Organisation

National Institute of Public Health, University of Southern Denmark

Sponsor details

Studiestræde 6
Copenhagen
1455
Denmark

Sponsor type

University/education

Website

https://www.sdu.dk/da/sif

Funders

Funder type

Other

Funder name

Helsefonden [the health foundation]

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis’ Legat

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Østifterne

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

TrygFonden Denmark

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol will be published in spring 2020. Publication of the study results and experiences is planned in a high-impact peer reviewed journal around one year after the end of the pilot study.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/04/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes