Developmental DelayPLUSSNCT04815889
Early Detection and Intervention in Developmental Delay / Behavioral Problems in Preschool Children - PLUSS
A study testing PRIMUS parent training Group in people with Developmental Delay and Behavioural Problem, run by Region Jönköping County at 1 site in Sweden.
Trial summary
The PLUSS (Mental health, learning, development, collaboration around preschool children) is a collaborative project involving guardians, Jönköping County´s health care, preschools and social services. Read more about this study
- Who is it for?
- Ages 18 to 72 months
- Conditions the study is for
- Developmental Delay, Behavioural Problem, Neurodevelopmental Delay
- What is being tested?
- PRIMUS parent training Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Development Delay
- Interaction, contact difficulties
- Language and communication difficulties
- Difficulties in everyday function
- Motor difficulties
- Concentration / hyperactive
Show all 10Show fewer
- Self-regulation
- Acting / boundaries
- Anxiety
- No claim to diagnosis
Who cannot join
- Not only support in the parent role, without any of the problems above.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Laura Korhonen, Prof contact
Sweden1 site, 1 recruiting
- Recruiting
Region Jönköping County "RJonkopingC"
Eksjö, Jönköping County, 57581
Berit M Gustafsson, PhD, +4602336846, berit.m.gustafsson@rjl.se
Laura Korhonen, Prof., laura.korhonen@liu.se
About this study
Official title: The PLUSS Model: a Study Protocol for Evaluation of a Multi-professional and Intersectoral Working Model to Detect Neurodevelopmental Difficulties in Preschool Children as Well as to Provide Parental Support
The PLUSS (Mental health, learning, development, collaboration around preschool children) is a collaborative project involving guardians, Jönköping County´s health care, preschools and social services. The project studies the implementation of a "One way in"-model that provides coordinated services to screen, evaluate and treat toddlers with behavioral problems. The project also provides parental interventions and education for preschool teachers.
The study aims to investigate a) implementation of the PLUSS model, b) effectiveness of the model and the included parental training program on behavioral problem and their longitudinal development among preschool children, c) parental wellbeing and satisfaction. In the long term, the goal is to reduce mental health problems among children, adolescents and their families and to provide support for a functioning everyday life.
Read the detailed description
The Jönköping Health Care managers for Child Health Care, Habilitation Center, Child and Adolescent Psychiatry and Rehabilitation Center (Speech Therapist) searched at 2018 government funding during this collaborative PLUSS-project. They have since money was awarded to the project in 2019, been formatted as a steering group for these clinical research project. An operational interprofessional working group appointed by the managers to conduct clinical and research work under the guidance of a disputed project manager of 40%. Information about the PLUSS-project and collaboration with the municipalities' activities (preschool and social services) started in 2019.
Ethics approval has been granted by the National Ethics Board (#2019-04839). Informed consent is obtained from all actors: both parents, managers, preschool educators, CHP and CHN. All data is registered with fp-number and is encoded directly at the time of collection considering the protection of privacy. Code template for translation between fp-no and the test subject can be found in a logbook that is kept inaccessible to unauthorized persons. The results are reported only at the group level, where no personal data will be recognizable. All data processing takes place following Swedish data law. The parents have been informed that they receive the same care whether they participate in the study or not. The project could cause concern for the parents as they answer the questionnaire and become aware of the child's possible problem. Here it is an advantage that the CHP uses the questionnaire in the assessment interview so that the parent has the opportunity to ask questions or talk about his child's needs and strengths. Recruitment of the control group is done through the county parts that have not yet been included in the clinical trial of new methods. This means that children/families are not withheld from treatment they would otherwise receive.
After the assessment interview and with the parents' consent, the Child Health psychologist contacts the child's preschool. The preschool manager and preschool teacher may consent to participate in the study and the preschool teacher answers questionnaires. The behavior of the children in the preschool will be paid extra attention to the teachers as they are asked to assess the behavior of the individual child. This could lead to children's problem behavior being highlighted in a way that can change how teacher's behaved towards individual children. However, an exaggerated emphasis on the negative is counteracted by the teacher being also asked to estimate the child's mental health in the form of commitment and social interaction. The project focuses on efforts in the child's environment that are helpful to all children, not just those with special needs.
- Being tested
- PRIMUS parent training Group
- Keywords
- Behavioural problems, Developmental Delay, Intervention, Preschool children, Screening
- Medical subject headings
- Learning Disabilities, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIMUS parent training GroupBehavioural
Also called Preschool and teacher training Group, Emotional Regulation parentgroup, Individual efforts in preschool, Individual efforts to parents
The parents offered a PRIMUS Group-based parent support program for 5 half days. This parenting education for preschool children with developmental problems but without the requirement of diagnosis Hellström (2019) has been designed and tested in other parts of the country but not scientifically validated, which can be done in this study. The teachers will be offered a teacher group for half a day together with the parents.
For those families who need more intervention the PLUSS toddler team (from the specialist Healthcare) is established.
The PLUSS toddler team makes a "management plan" as referral to Habilitation Center, Child and Adolescent Psychiatry, Speech Therapist, or interventions eg:
- Support in the child's everyday environment home / preschool
- Targeted Parent Groups: toilet, sleep, food, everyday structure, handle behavioural problems
- Web courses
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Recruitment of the control group is done through the county parts that have not yet been included in the clinical trial of new methods. This means that children / families are not withheld from treatment they would otherwise receive. |
| PRIMUS parent training group and preschool teacher training group | Active comparator | The parents have undergone PRIMUS Group-based parent support program for 5 half days This parenting education for preschool children with developmental problems but without the requirement of diagnosis Hellström (2019) has been designed and tested in other parts of the country but not scientifically validated, which can be done in this study. The preschool teachers may participate for half a day in education together with the parents as a practical implementation in the child's everyday life. Receives: Behavioral: PRIMUS parent training Group |
| Demand-driven intervention | Other | The PLUSS toddler team makes a "management plan" as referral to Habilitation Center, Child and Adolescent Psychiatry, Speech Therapist, or interventions eg:
* Support in the child's everyday environment home / preschool
* Targeted parent training group: toilet, sleep, food, everyday structure, handle behavioural problems
* Web Courses Each individual intervention is evaluated afterwards with the study questionnaire. Receives: Behavioral: PRIMUS parent training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and Difficulties questionnaire (SDQ
Measured with Behavioral problems with 25 items divided into 5 subscales of 5 items each, generating scores for 4 problem subscales: Conduct problems, Hyperactivity, Emotional problems and Peer problems, and 1 strength subscale: Prosocial behaviours. Responses are given on a 3-point Likert scale: (0) "not true" (1) "somewhat true" (2) "certainly true". The total scores for the behavioural difficulties scale are maximum 50 points (worse outcome), minimum 0 points (best outcome).
The impairment supplement questions, which describe how behavioural problems affect the child's level of functioning, are subsequently included in the impact score. Ratings for these 8 impairment supplement questions are: (0) "not at all" and (0) "only a little" (1) "quite a lot" and (2) "a great deal". Maximum 16 points (worse outcome), minimum 0 points (best outcome) (Goodman, 2016). SDQ is validated and proposed cut-offs are available for Swedish conditions (Goodman, 2016; Gustafsson et al, 2016).
Measured: Change from baseline, pre intervention.Up to 24 weeks.
Secondary outcomes (3)
Children's engagement questionnaire (CEQ)
Functioning, Mental Health: Children's engagement questionnaire (CEQ) is a form of 29 questions. Compared with the following alternatives: (1) almost never happens (2) sometimes happens (3) happens quite often or (4) happens very often. The maximum score is 116 and the minimum score is 0. It is positive to have as high a score as possible. It measures children's targeted engagement and social interaction in preschool children's everyday life and is validated for Swedish conditions (Mc William, 1991).
Measured: Change from baseline, pre intervention. Up to 24 weeks.
Measured with the Observation instrument Joint Attentment observations (JA-OBS)
Autism spectrum: Measured with the Observation instrument Joint Attentment observations (JA-OBS) how includes 5 questions and are a Autism spectrum screening instrument (Sweden County Councils and Regions, 2018). Maximum score = 5, minimum score = 0. 4-5 points show no signs of autism spectrum symptoms.
Measured: Baseline when the child is on a 2.5 year check-up with the CHC nurse
Psychosocial problems in the family (LAPS)
Psychosocial problems in the family: LAPS, translated from Finnish where this form is filled in by Health Care staff. The form has been developed and tested within the framework of the project for the development of mental health work among children 2007-2009 (Mäki et al, 2014). LAPS consists of 16 items with 3 answer options. The instrument is not validated or standardized for Swedish conditions. There are cut-off figures based on Finnish conditions that show when support for the family should be offered (5-7 points for primary care and over 8 points for specialist care). The form is filled in by the BHV psychologist at the first assessment interview with the guardians. To be filled in by the BHV psychologist and can be graded in no (0), mild (1) and severe symptoms (2). The maximum score on the instrument is 32 and then indicates severe symptoms in all items.
Measured: Change from baselaine, pre intervention. Up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Aug 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Developmental DelayStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- All families receive the first interventions, which are PRIMUS parent education and teacher education. Then the families receive different interventions based on need. The control group receives treatment as usual.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Collaborators
- Linkoeping University
- Responsible party
- Sponsor
- Investigators
- Berit M Gustafsson, PhD, Principal investigator, Region Jönköping County "RJonkopingC"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815889
- Sponsor's protocol ID
- RJonkopingC
- Acronym
- PLUSS
- Status last verified
- May 2025
- First submitted
- 16 Mar 2021
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not supposed to share the data of the ethical considerations.
Publications
Gustafsson BM, Korhonen L. A Multiprofessional and Intersectoral Working Model to Detect and Support Preschool Children With Neurodevelopmental Difficulties (PLUSS Model): Protocol for an Evaluation Study. JMIR Res Protoc. 2022 Jun 15;11(6):e34969. doi: 10.2196/34969.
PubMed 35704376Gustafsson BM, Steinwall S, Korhonen L. Multi-professional and multi-agency model PLUSS to facilitate early detection and support of pre-school children with neurodevelopmental difficulties - a model description. BMC Health Serv Res. 2022 Mar 30;22(1):419. doi: 10.1186/s12913-022-07815-8.
PubMed 35354442
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PLUSS Model: a Study Protocol for Evaluation of a Multi-professional and Intersectoral Working Model to Detect Neurodevelopmental Difficulties in Preschool Children as Well as to Provide Parental Support
- ClinicalTrials.gov ID
- NCT04815889
- Acronym / sponsor ID
- PLUSS / RJonkopingC
- Keywords
- Behavioural problems, Developmental Delay, Intervention, Preschool children, Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Region Jönköping CountyOther government
- Collaborators
- Linkoeping University
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Mar 2021 (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 PLUSS (Mental health, learning, development, collaboration around preschool children) is a collaborative project involving guardians, Jönköping County´s health care, preschools and social services. The project studies the implementation of a "One way in"-model that provides coordinated services to screen, evaluate and treat toddlers with behavioral problems. The project also provides parental interventions and education for preschool teachers.
The study aims to investigate a) implementation of the PLUSS model, b) effectiveness of the model and the included parental training program on behavioral problem and their longitudinal development among preschool children, c) parental wellbeing and satisfaction. In the long term, the goal is to reduce mental health problems among children, adolescents and their families and to provide support for a functioning everyday life.
Detailed description
The Jönköping Health Care managers for Child Health Care, Habilitation Center, Child and Adolescent Psychiatry and Rehabilitation Center (Speech Therapist) searched at 2018 government funding during this collaborative PLUSS-project. They have since money was awarded to the project in 2019, been formatted as a steering group for these clinical research project. An operational interprofessional working group appointed by the managers to conduct clinical and research work under the guidance of a disputed project manager of 40%. Information about the PLUSS-project and collaboration with the municipalities' activities (preschool and social services) started in 2019.
Ethics approval has been granted by the National Ethics Board (#2019-04839). Informed consent is obtained from all actors: both parents, managers, preschool educators, CHP and CHN. All data is registered with fp-number and is encoded directly at the time of collection considering the protection of privacy. Code template for translation between fp-no and the test subject can be found in a logbook that is kept inaccessible to unauthorized persons. The results are reported only at the group level, where no personal data will be recognizable. All data processing takes place following Swedish data law. The parents have been informed that they receive the same care whether they participate in the study or not. The project could cause concern for the parents as they answer the questionnaire and become aware of the child's possible problem. Here it is an advantage that the CHP uses the questionnaire in the assessment interview so that the parent has the opportunity to ask questions or talk about his child's needs and strengths. Recruitment of the control group is done through the county parts that have not yet been included in the clinical trial of new methods. This means that children/families are not withheld from treatment they would otherwise receive.
After the assessment interview and with the parents' consent, the Child Health psychologist contacts the child's preschool. The preschool manager and preschool teacher may consent to participate in the study and the preschool teacher answers questionnaires. The behavior of the children in the preschool will be paid extra attention to the teachers as they are asked to assess the behavior of the individual child. This could lead to children's problem behavior being highlighted in a way that can change how teacher's behaved towards individual children. However, an exaggerated emphasis on the negative is counteracted by the teacher being also asked to estimate the child's mental health in the form of commitment and social interaction. The project focuses on efforts in the child's environment that are helpful to all children, not just those with special needs.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- All families receive the first interventions, which are PRIMUS parent education and teacher education. Then the families receive different interventions based on need. The control group receives treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Recruitment of the control group is done through the county parts that have not yet been included in the clinical trial of new methods. This means that children / families are not withheld from treatment they would otherwise receive. |
| PRIMUS parent training group and preschool teacher training group | Active comparator | Behavioral: PRIMUS parent training GroupThe parents have undergone PRIMUS Group-based parent support program for 5 half days This parenting education for preschool children with developmental problems but without the requirement of diagnosis Hellström (2019) has been designed and tested in other parts of the country but not scientifically validated, which can be done in this study. The preschool teachers may participate for half a day in education together with the parents as a practical implementation in the child's everyday life. |
| Demand-driven intervention | Other | Behavioral: PRIMUS parent training GroupThe PLUSS toddler team makes a "management plan" as referral to Habilitation Center, Child and Adolescent Psychiatry, Speech Therapist, or interventions eg: * Support in the child's everyday environment home / preschool * Targeted parent training group: toilet, sleep, food, everyday structure, handle behavioural problems * Web Courses Each individual intervention is evaluated afterwards with the study questionnaire. |
Who may qualify
- Ages
- 18 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Development Delay
- Interaction, contact difficulties
- Language and communication difficulties
- Difficulties in everyday function
- Motor difficulties
Key exclusion criteria (1 listed)
- Not only support in the parent role, without any of the problems above.
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 |
|---|---|---|
| PRIMUS parent training GroupAlso: Preschool and teacher training Group, Emotional Regulation parentgroup, Individual efforts in preschool, Individual efforts to parentsThe parents offered a PRIMUS Group-based parent support program for 5 half days. This parenting education for preschool children with developmental problems but without the requirement of diagnosis Hellström (2019) has been designed and tested in other parts of the country but not scientifically validated, which can be done in this study. The teachers will be offered a teacher group for half a day together with the parents. For those families who need more intervention the PLUSS toddler team (from the specialist Healthcare) is established. The PLUSS toddler team makes a "management plan" as referral to Habilitation Center, Child and Adolescent Psychiatry, Speech Therapist, or interventions eg: * Support in the child's everyday environment home / preschool * Targeted Parent Groups: toilet, sleep, food, everyday structure, handle behavioural problems * Web courses | Behavioural | Demand-driven intervention, PRIMUS parent training group and preschool teacher training group |
Primary outcome
Strengths and Difficulties questionnaire (SDQ
Time frame: Change from baseline, pre intervention.Up to 24 weeks.
Measured with Behavioral problems with 25 items divided into 5 subscales of 5 items each, generating scores for 4 problem subscales: Conduct problems, Hyperactivity, Emotional problems and Peer problems, and 1 strength subscale: Prosocial behaviours. Responses are given on a 3-point Likert scale: (0) "not true" (1) "somewhat true" (2) "certainly true". The total scores for the behavioural difficulties scale are maximum 50 points (worse outcome), minimum 0 points (best outcome). The impairment supplement questions, which describe how behavioural problems affect the child's level of functioning, are subsequently included in the impact score. Ratings for these 8 impairment supplement questions are: (0) "not at all" and (0) "only a little" (1) "quite a lot" and (2) "a great deal". Maximum 16 points (worse outcome), minimum 0 points (best outcome) (Goodman, 2016). SDQ is validated and proposed cut-offs are available for Swedish conditions (Goodman, 2016; Gustafsson et al, 2016).
3 secondary outcomes
Children's engagement questionnaire (CEQ)
Time frame: Change from baseline, pre intervention. Up to 24 weeks.
Measured with the Observation instrument Joint Attentment observations (JA-OBS)
Time frame: Baseline when the child is on a 2.5 year check-up with the CHC nurse
Psychosocial problems in the family (LAPS)
Time frame: Change from baselaine, pre intervention. Up to 24 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Results publication: PubMed 35704376Gustafsson BM, Korhonen L. A Multiprofessional and Intersectoral Working Model to Detect and Support Preschool Children With Neurodevelopmental Difficulties (PLUSS Model): Protocol for an Evaluation Study. JMIR Res Protoc. 2022 Jun 15;11(6):e34969. doi: 10.2196/34969.
- Derived from this study: PubMed 35354442Gustafsson BM, Steinwall S, Korhonen L. Multi-professional and multi-agency model PLUSS to facilitate early detection and support of pre-school children with neurodevelopmental difficulties - a model description. BMC Health Serv Res. 2022 Mar 30;22(1):419. doi: 10.1186/s12913-022-07815-8.
- A Multiprofessional and Intersectoral Working Model to Detect and Support Preschool Children With Neurodevelopmental Difficulties (PLUSS Model): Protocol for an Evaluation StudyLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. We are not supposed to share the data of the ethical considerations.
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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.
Laura Korhonen, Prof contact
Berit M Gustafsson, PhD principal investigator
Region Jönköping County "RJonkopingC"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIMUS parent training Group in people with Developmental Delay and Behavioural Problem, run by Region Jönköping County 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 10 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: looking for participants now, as of the sponsor's last update on 21 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berit M Gustafsson, PhD (+4602336846, berit.m.gustafsson@rjl.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Difficulties questionnaire (SDQ (time frame: Change from baseline, pre intervention.Up to 24 weeks.). 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 NCT04815889, which also lists 2 linked publications.
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 21 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.