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

NCT04815889 | Recruiting

• 1 other identifier: RJonkopingC
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Developmental Delay; Behavioural Problem; Neurodevelopmental Delay

Keywords

Behavioural problems; Developmental Delay; Intervention; Preschool children; Screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Children's engagement questionnaire (CEQ)

  Change from baseline, pre intervention. Up to 24 weeks.

• Measured with the Observation instrument Joint Attentment observations (JA-OBS)

  Baseline when the child is on a 2.5 year check-up with the CHC nurse

• Psychosocial problems in the family (LAPS)

  Change from baselaine, pre intervention. Up to 24 weeks.

Study Arms (3)

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.

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.

Behavioral: PRIMUS parent training Group

Interventions

PRIMUS parent training Group BEHAVIORAL

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

Also known as: Preschool and teacher training Group, Emotional Regulation parentgroup, Individual efforts in preschool, Individual efforts to parents

Demand-driven intervention; PRIMUS parent training group and preschool teacher training group

Eligibility Criteria

• Age: 18 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Region Jönköping County: lead
• Linkoeping University: collaborator

Study Sites (1)

Region Jönköping County "RJonkopingC"

Eksjö, Jönköping County, 57581, Sweden

RECRUITING

Related Publications (2)

• 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.

  PMID: 35704376 RESULT

• 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.

  PMID: 35354442 DERIVED

Related Links

• A Multiprofessional and Intersectoral Working Model to Detect and Support Preschool Children With Neurodevelopmental Difficulties (PLUSS Model): Protocol for an Evaluation Study
• Related Info

MeSH Terms

Conditions

Learning Disabilities; Mental Disorders

Interventions

Schools, Nursery

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Schools; Non-Medical Public and Private Facilities

Study Officials

• Berit M Gustafsson, PhD

  Region Jönköping County "RJonkopingC"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Berit M Gustafsson, PhD

CONTACT

+4602336846; berit.m.gustafsson@rjl.se

Laura Korhonen, Prof

CONTACT

laura.korhonen@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Children who are referred to a Child Health psychologist at the age of 1.5-4 (mostly after 2.5 years of supervision at the Child Health Nurse). Informants are parents, preschool teachers, child health care psychologists and nurses.
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 25, 2021
• Study Start: August 1, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)