ClinicalTrials.gg
RecruitingNCT06984809Updated Jun 29, 2026

Evaluation of the Invest in Play Program - a New Parent Intervention for Children With Problem Behavior

An interventional study of Intervention in Problem Behavior and Attention Deficit and Disruptive Behavior Disorders, sponsored by University of Tromso. Recruiting at 5 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by University of Tromso · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Problem Behavior
  • Attention Deficit and Disruptive Behavior Disorders

Keywords

  • parent intervention
  • parent practices
  • emotion regulation
  • parent-child relationship
  • parental attributions
03

In context

Problem Behavior

178 studies on the registry are indexed under Problem Behavior; 47 are open to participants now.

This study's planned enrollment of 180 is above the median of 90 across 165 interventional studies indexed under Problem Behavior.

Browse Problem Behavior studies →

Lead sponsor

University of Tromso is the lead sponsor of 60 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

- 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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • No intervention
    Control group

    The control condition will receive usual care, e.g., further assessments, school meetings, individual care and/or psycho education.

  • Experimental
    Invest in Play group

    Intervention group receiving Invest in Play (iiP), a 12 session program provided weekly to parents with children with problem behavior.

    Behavioral: Intervention

Interventions

  • BehavioralIntervention

    The intervention group will receive Invest in Play (iiP), a 12 session group-based parent program, which is led by two trained group leaders.

    Also known as: Invest in Play (iiP)

06

What researchers measure

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.

    Time frame: From baseline to the end of treatment at 12 weeks.

Secondary outcomes

  1. 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.

    Time frame: From baseline to the end of treatment at 12 weeks.

  2. 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.

    Time frame: From baseline to the end of treatment at 12 weeks.

  3. 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.

    Time frame: From baseline to the end of treatment at 12 weeks.

  4. 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.

    Time frame: From baseline to the end of treatment at 12 weeks.

  5. 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.

    Time frame: From baseline to the end of treatment at 12 weeks.

  6. 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.

    Time frame: From baseline to the end of treatment at 12 weeks.

  7. 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.

    Time frame: From baseline to the end of treatment at 12 weeks.

  8. 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.

    Time frame: From baseline to the end of treatment at 12 weeks.

Other outcomes

  1. Change in Eyberg Child Behavioral Inventory (ECBI) score from post-intervention to three months follow up.

    Investigators want to assess whether the scores changes in the Invest in Play intervention group three months post intervention. The Eyberg Child Behavioral Inventory (ECBI) is a well-validated measure for evaluating child problem behavior. 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.

    Time frame: From post-treatment to three months post intervention.

  2. Change in the Social Competence Scale-Parent (SCS-P) score from post-intervention to three months follow up.

    Investigators want to assess whether the scores changes in the Invest in Play intervention group three months post intervention. The 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.

    Time frame: From post-treatment to three months post intervention.

  3. Change in Kidscreen-10 score from post-intervention to three months follow up.

    Investigators want to assess whether the scores changes in the Invest in Play intervention group three months post intervention. 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.

    Time frame: From post-treatment to three months post intervention.

  4. Change in Strengths and Difficulties Questionnaire (SDQ) score from post-intervention to three months follow up.

    Investigators want to assess whether the scores changes in the Invest in Play intervention group three months post intervention. 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.

    Time frame: From post-treatment to three months post intervention.

  5. Change in the Parenting and Family Adjustment Scales (PAFAS) from post-intervention to three months follow up.

    Investigators want to assess whether the scores changes in the Invest in Play intervention group three months post intervention. 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

    Time frame: From post-treatment to three months post intervention.

  6. Change in the Parent Stress Scale (PSS) from post-intervention to three months follow up.

    Investigators want to assess whether the scores changes in the Invest in Play intervention group three months post intervention. 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.

    Time frame: From post-treatment to three months post intervention.

  7. Change in the Parent Cognition Scale (PCS) score from post-intervention to three months follow up.

    Investigators want to assess whether the scores changes in the Invest in Play intervention group three months post intervention. 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.

    Time frame: From post-treatment to three months post intervention.

  8. Change in the Me as parent - Short form (MaaPs-SF) score from post intervention to three months follow up.

    Investigators want to assess whether the scores changes in the Invest in Play intervention group three months post intervention. Me as parent - Short form (MaaPs-SF; Matthews, et al., 2022) 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.

    Time frame: From post-treatment to three months post intervention.

  9. Change in the Parental Emotion Regulation Inventory (PERI-2) from post intervention to three months follow up.

    Investigators want to assess whether the scores changes in the Invest in Play intervention group three months post intervention. 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 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.

    Time frame: From post-treatment to three months post intervention.

07

Study locations

4 of 5 sites recruiting
  • Betanien Hospital
    Bergen, Fyllingdalen 5145, Norway
    Recruiting
  • Haukeland university hospital, department of mental health care for children and adolescents
    Bergen, 5021, Norway
    Recruiting
  • Helse Fonna HF, BUP Stord
    Haugesund, Norway
    Recruiting
  • Helse Nord-Trøndelag HF, Barne- og ungdomspsykiatrisk avdeling (BUP)
    Namsos, Norway
    Active, not recruiting

    Not enrolling at this site.

  • OUS/PHA/BUPA/BUP Oslo Nord
    Oslo, Norway
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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).

Supporting information: Informed consent form

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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Dec 2028, 39 months after the start.

Of 111 non-industry interventional studies with no phase under Problem Behavior, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 39 months is above that.

Counting every sponsor, half of 112 studies reached it within 24 months; a quarter within 13 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2025
First posted
May 22, 2025
StartActual
Sep 25, 2025
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Jun 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06984809
Lead sponsor
University of Tromso
Collaborators
NORCE Norwegian Research Centre AS, Norwegian University of Science and Technology
Responsible party
Sponsor
First posted
May 22, 2025
Start date
Sep 25, 2025
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jun 29, 2026

Study contacts

Kurt Henrik Dalmo, Ph.d.
Contact
kurt.h.dalmo@uit.no
+4777660306
Geraldine Mabille, Ph.d.
Contact
geraldine.mabille@uit.no
+4777645864
Lene-Mari P. Rasmussen, Ph.d
principal investigator · UiT The Arctic University of Norway

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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