Early Detection and Intervention in Developmental Delay / Behavioral Problems in Preschool Children - PLUSS (PLUSS)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Developmental Delay; Behavioural Problem
• Intervention / Treatment: Behavioral: PRIMUS parent training Group

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Jönköping
    • Eksjö, Jönköping, Sweden, 57581
      • Region Jönköping County "RJonkopingC"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Development Delay
• Interaction, contact difficulties
• Language and communication difficulties
• Difficulties in everyday function
• Motor difficulties
• Concentration / hyperactive
• Self-regulation
• Acting / boundaries
• Anxiety
• No claim to diagnosis

Exclusion Criteria:

• Not only support in the parent role, without any of the problems above.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 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.
Active Comparator: PRIMUS parent training group and preschool teacher training group; 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.	Behavioral: PRIMUS parent training Group; 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; Other Names: Preschool and teacher training Group; Emotional Regulation parentgroup; Individual efforts in preschool; Individual efforts to parents
Other: Demand-driven intervention; 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.	Behavioral: PRIMUS parent training Group; 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; Other Names: Preschool and teacher training Group; Emotional Regulation parentgroup; Individual efforts in preschool; Individual efforts to parents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Change from baseline, pre intervention.Up to 24 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	Change from baselaine, pre intervention. Up to 24 weeks.

Collaborators and Investigators

• Sponsor: Region Jönköping County
• Collaborators: Linkoeping University
• Investigators: Principal Investigator: Berit M Gustafsson, PhD, Region Jönköping County "RJonkopingC"

Publications and helpful links

General 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.
• Gustafsson 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.

Helpful Links

• Identifying Patterns of Emotional and Behavioural Problems in Preschool children - Facilitating Early Detection

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Screening; Behavioural problems; Intervention; Preschool children; Developmental Delay
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior
• Other Study ID Numbers: RJonkopingC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not supposed to share the data of the ethical considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No