Early Detection and Intervention in Developmental Delay / Behavioral Problems in Preschool Children - PLUSS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-72
SponsorRegion Jönköping County
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Development Delay
Interaction, contact difficulties
Language and communication difficulties
Difficulties in everyday function
Disqualifiers
Not only support in the parent role, without any of the problems above.
Trial design
Design model
Factorial
Treatments tested in this trial
PRIMUS parent training Group
BehavioralThe 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
Treatment groups
600 Participants
are divided into 3 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: PRIMUS parent training group and preschool teacher training groupActive comparator 1 intervention
Group C: Demand-driven interventionOther 1 intervention
Trial outcomes
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).
Time frame
Change from baseline, pre intervention.Up to 24 weeks.Secondary outcomes
1
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).
Time frame
Change from baseline, pre intervention. Up to 24 weeks.2
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.
Time frame
Baseline when the child is on a 2.5 year check-up with the CHC nurse3
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.
Time frame
Change from baselaine, pre intervention. Up to 24 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Jönköping County
Lead sponsor
Linkoeping University
Collaborator
Source ClinicalTrials.gov