Evaluation of the Invest in Play Program - a New Parent Intervention for Children With Problem Behavior
2 other identifiers
interventional
180
1 country
4
Brief Summary
The goal of this clinical trial is to test if the invest in Play (iiP) parent program can reduce problem behaviors in children and improve parenting practices in families with children who show challenging behaviors. The main questions it aims to answer is: • Does the iiP program reduce children's problem behaviors? Researchers will compare families in the iiP program to families in a control group to see if the program leads to better outcomes for children and parents. Participants will be randomly assigned to either the iiP program group or the control group and complete surveys before and after the program to see if iiP is reducing children's problem behaviors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2025
CompletedFirst Posted
Study publicly available on registry
May 22, 2025
CompletedStudy Start
First participant enrolled
September 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
December 22, 2025
September 1, 2025
3.2 years
May 9, 2025
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Eyberg Child Behavior Inventory (ECBI) score at different time points (from baseline up to 12 weeks).
Child problem behavior will be measured using the Eyberg Child Behavior Inventory (ECBI), where the change score from baseline to 12 weeks post intervention is the primary outcome. The measure consists of 36 items, which is scored on parents' notion about the intensity (1 = never to 7 = always), and whether child behavior is a problem (0 = no and 1 = yes, range 0-36). A total score is calculated, ranging from range 36-252. High intensity scores indicate more intense problems, and a high problem score indicate a higher frequency of problem behaviors. The ECBI has demonstrated strong internal consistency, test-retest reliability, and discriminant validity and has been shown to be a sensitive indicator of intervention efficacy for child behavior problems.
From baseline to the end of treatment at 12 weeks.
Secondary Outcomes (8)
Change in the Social Competence Scale-Parent (SCS-P) score at different time points (from baseline up to 12 weeks).
From baseline to the end of treatment at 12 weeks.
Change in the Kidscreen-10 score at different time points (from baseline up to 12 weeks).
From baseline to the end of treatment at 12 weeks.
Change in Strengths and Difficulties Questionnaire (SDQ) score at different time points (from baseline up to 12 weeks).
From baseline to the end of treatment at 12 weeks.
Change in the Parenting and Family Adjustment Scales (PAFAS) score at different time points (from baseline up to 12 weeks).
From baseline to the end of treatment at 12 weeks.
Change in the Parent Stress Scale (PSS) scores at different time points (from baseline up to 12 weeks).
From baseline to the end of treatment at 12 weeks.
- +3 more secondary outcomes
Other Outcomes (9)
Change in Eyberg Child Behavioral Inventory (ECBI) score from post-intervention to three months follow up.
From post-treatment to three months post intervention.
Change in the Social Competence Scale-Parent (SCS-P) score from post-intervention to three months follow up.
From post-treatment to three months post intervention.
Change in Kidscreen-10 score from post-intervention to three months follow up.
From post-treatment to three months post intervention.
- +6 more other outcomes
Study Arms (2)
Control group
NO INTERVENTIONThe control condition will receive usual care, e.g., further assessments, school meetings, individual care and/or psycho education.
Invest in Play group
EXPERIMENTALIntervention group receiving Invest in Play (iiP), a 12 session program provided weekly to parents with children with problem behavior.
Interventions
The intervention group will receive Invest in Play (iiP), a 12 session group-based parent program, which is led by two trained group leaders.
Eligibility Criteria
You may qualify if:
- Parents of children between 6-12 years of age referred to out-patient clinics for treatment of behavioural problems.
- Children scoring above a pre-defined mean cut off score (over the 90 percentile) on the Eyberg Child Behavior Inventory (ECBI; Eyberg \& Ross, 1978) based on Norwegian norms (Reedtz et al., 2008), as reported by parents.
You may not qualify if:
- \- Severe developmental delay (in children or parents), autism spectrum disorder, inability to understand Norwegian, or other reasons why the parent(s) are not expected to benefit from group therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Tromsolead
- NORCE Norwegian Research Centre AScollaborator
- NTNU Health (sponsor)collaborator
Study Sites (4)
Haukeland university hospital, department of mental health care for children and adolescents
Bergen, 5021, Norway
Helse Fonna HF, BUP Stord
Haugesund, Norway
Helse Nord-Trøndelag HF, Barne- og ungdomspsykiatrisk avdeling (BUP)
Namsos, Norway
OUS/PHA/BUPA/BUP Oslo Nord
Oslo, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lene-Mari P. Rasmussen, Ph.d
UiT The Arctic University of Norway
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2025
First Posted
May 22, 2025
Study Start
September 25, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
December 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- 31.12.2028-31.12.2033.
- Access Criteria
- Reasearcher affiliated to recognized academic institutions can request access by taking contact with a proposal that describes planned analyses must be submitted and will be evaluated by the project leader and data manager.
De-identified data (data where personal identifying characteristics have been removed) may be shared with national or international collaborators in Denmark and the Netherlands for use in comparative studies. This primarily applies to information related to the child's behavior, parental stress, and user satisfaction. Data from the study can also be made available for other researchers upon request (see details below under access criteria).