Problem BehaviorNCT06984809
Evaluation of the Invest in Play Program - a New Parent Intervention for Children With Problem Behavior
A study testing Intervention in people with Problem Behavior and Attention Deficit and Disruptive Behavior Disorders, run by University of Tromso at 5 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Problem Behavior, Attention Deficit and Disruptive Behavior Disorders
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 5 sitesNorway
- Study dates
- 25 Sep 2025to Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Norway5 sites, 4 recruiting
- Recruiting
Betanien Hospital
Bergen, Fyllingdalen, 5145
Daniel A. Jensen, Ph.d., +47 55 50 73 50, daniel.andre.jensen@betaniensykehus.no
- Recruiting
Haukeland university hospital, department of mental health care for children and adolescents
Bergen, 5021
Bjørn Brunborg, bjbr@norcereasearch.no
- Recruiting
Helse Fonna HF, BUP Stord
Haugesund
Ingvild Kaldråstøyl, +4752732068, ingvild.kaldrastoyl@helse-fonna.no
Helge Børresen, +4752732068, helge.borresen@helse-fonna.no
- Active, not recruiting
Helse Nord-Trøndelag HF, Barne- og ungdomspsykiatrisk avdeling (BUP)
Namsos
- Recruiting
OUS/PHA/BUPA/BUP Oslo Nord
Oslo
Gaute Skribekk, lic.jur, +4723023900, gauski@ous-hf.no
Marianne Robertsen, +4723023900, mrober@ous-hf.no
About this study
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.
- Being tested
- Intervention
- Keywords
- parent intervention, parent practices, emotion regulation, parent-child relationship, parental attributions
- Medical subject headings
- Problem Behavior, Attention Deficit and Disruptive Behavior Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Also called Invest in Play (iiP)
The intervention group will receive Invest in Play (iiP), a 12 session group-based parent program, which is led by two trained group leaders.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control condition will receive usual care, e.g., further assessments, school meetings, individual care and/or psycho education. |
| Invest in Play group | Experimental | Intervention group receiving Invest in Play (iiP), a 12 session program provided weekly to parents with children with problem behavior. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Social Competence Scale-Parent (SCS-P) is a 12-item measure for assessing two domains of children's social competence, namely prosocial skills ("Your child can give suggestions and opinions without being bossy") and emotion regulation (e.g., "Your child can calm down when excited or all wound up."). The items are rated on a scale from 0 = "Not at all" to 4 = "Very well". For this study, the emotion regulation skills subscale (6 items) will be used, and the subscale is scored as a mean of responses, where higher scores indicate better emotion regulation.
Measured: 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).
Kidscreen-10 index parent version measures children's health related global quality of life (HRQoL). The 10-item version is the short version of the KIDSCREEN-52 and KIDSCREEN-27 instrument and is rated on a scale from 1 = "Not at all" to 5 = "to a large extent". A total score is calculated, where higher scores indicates better HRQoL.
Measured: 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).
The Strength and Difficulties Questionnaire (SDQ) is a brief behavioral screening questionnaire consisting of 25 items, divided by on 5 subscales (prosocial, hyperactivity, emotional symptoms, conduct problems and peer problems), scored from 0 = not true, 1 = somewhat true and 2 = certainly true. The parent version will be used in this study. A total score from each subscale is calculated. In addition, the last four subscales are added together to generate a total difficulties score (based on 20 items), where a higher score indicate more difficulties.
Measured: 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).
Parenting and Family Adjustment Scales (PAFAS) is a 40-item measure assessing parent and family functioning through five domains (parenting practices, quality of parent-child relationship, parental emotional adjustment, positive family relationships, and parental teamwork), which are all considered to be important for child outcomes. The items are rated on a 4-point scale from 0 = not true for me at all to 3 = true of me very much. The scores are summed (some scores are reversed), where higher scores indicate a more dysfunctional family life.
Measured: 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).
The Parent Stress Scale (PSS) is an 18-item questionnaire assessing parents' feelings about their parenting role, exploring both positive aspects (e.g. emotional benefits, personal development) and negative aspects of parenthood (e.g. demands on resources, feelings of stress). The scale is rated on a 5-point scale from 1 = Strongly disagree to 5 = Strongly agree. Some of the scores are reversed, and a total score is calculated. A high score indicate high stress levels. We will use the subscale with six items addressing parent stress and the more negative aspects of parenthood in this study.
Measured: From baseline to the end of treatment at 12 weeks.
Change in the Parent Cognition Scale (PCS) score at different time points (from baseline up to 12 weeks).
The Parent Cognition Scale (PCS) is a 16-item self-report measure of parental attributions of child behavior. The scale consists of two subscales, which assesses child-responsible attributions (e.g., "I'm not structured enough with my child") and parent-causal attribution (e.g., "I'm not structured enough with my child"). The items are rated on a scale from 0 = always true to 5 = never true, all being reverse scored. This means that higher scores indicate more negative attributions.
Measured: From baseline to the end of treatment at 12 weeks.
Change in the Me as parent - Short form (MaaPs-SF) score at different time points (from baseline up to 12 weeks).
Me as parent - Short form (MaaPs-SF) is a four-item measure to assess parent self-efficacy. The scale is derived from the original 16-item version (Hamilton et al., 2014), developed to assess parenting self-regulation. The MaaPs-SF is rated on a 5-point scale from 1 = Strongly disagree to 5 = Strongly agree. The four items are added to provide a total score, where a higher score indicates better parenting self-efficacy.
Measured: From baseline to the end of treatment at 12 weeks.
Change in the Parental Emotion Regulation Inventory (PERI-2) score at different time points (from baseline up to 12 weeks).
The Parental Emotion Regulation Inventory (PERI-2) is a 23-item self-report measure to assess parents own self-regulation. The items consist of different emotion regulation strategies which are rated on a 7-point scale ranging from 1 (I never do this) to 7 (I very often do this), comprising four different subscales (Reappraisal, Suppression, Escape and Capitulation). A score for each subscale is calculated, where a high score indicate that the strategies within that factor are more used.
Measured: From baseline to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start25 Sep 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem BehaviorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- NORCE Norwegian Research Centre AS, Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Lene-Mari P. Rasmussen, Ph.d, Principal investigator, UiT The Arctic University of Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984809
- Sponsor's protocol ID
- 2024/785387
- Other IDs
- 2025-957314, 2025
- Status last verified
- Jun 2026
- First submitted
- 9 May 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Invest in Play Program - a New Parent Intervention for Children With Problem Behavior
- ClinicalTrials.gov ID
- NCT06984809
- Acronym / sponsor ID
- 2024/785387
- Keywords
- parent intervention, parent practices, emotion regulation, parent-child relationship, parental attributions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- NORCE Norwegian Research Centre AS, Norwegian University of Science and Technology
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 May 2025 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control condition will receive usual care, e.g., further assessments, school meetings, individual care and/or psycho education. |
| Invest in Play group | Experimental | Behavioral: InterventionIntervention group receiving Invest in Play (iiP), a 12 session program provided weekly to parents with children with problem behavior. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| InterventionAlso: Invest in Play (iiP)The intervention group will receive Invest in Play (iiP), a 12 session group-based parent program, which is led by two trained group leaders. | Behavioural | Invest in Play group |
Primary outcome
Change in the Eyberg Child Behavior Inventory (ECBI) score at different time points (from baseline up to 12 weeks).
Time frame: From baseline to the end of treatment at 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.
8 secondary outcomes
Change in the Social Competence Scale-Parent (SCS-P) score at different time points (from baseline up to 12 weeks).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: From baseline to the end of treatment at 12 weeks.
Change in the Parent Cognition Scale (PCS) score at different time points (from baseline up to 12 weeks).
Time frame: From baseline to the end of treatment at 12 weeks.
Change in the Me as parent - Short form (MaaPs-SF) score at different time points (from baseline up to 12 weeks).
Time frame: From baseline to the end of treatment at 12 weeks.
Change in the Parental Emotion Regulation Inventory (PERI-2) score at different time points (from baseline up to 12 weeks).
Time frame: From baseline to the end of treatment at 12 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 29 Jun 2026.
- Individual participant dataSharing planned: Yes. 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).
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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.
Lene-Mari P. Rasmussen, Ph.d principal investigator
UiT The Arctic University of Norway
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Problem Behavior and Attention Deficit and Disruptive Behavior Disorders, run by University of Tromso at 5 sites in Norway.
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 2 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 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. 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 Kurt Henrik Dalmo, Ph.d. (+4777660306, kurt.h.dalmo@uit.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Eyberg Child Behavior Inventory (ECBI) score at different time points (from baseline up to 12 weeks). (time frame: From baseline to the end of treatment at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.