Clinical trial NCT06984809: Evaluation of the Invest in Play Program - a New Parent Intervention for Children With Problem Behavior
Official title: Evaluation of the Invest in Play Program - a New Parent Intervention for Children With Problem Behavior
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Keywords: parent intervention
parent practices
emotion regulation
parent-child relationship
parental attributions
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: NORCE Norwegian Research Centre AS
name: NTNU Health (sponsor)
First posted: 2025-05-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

- 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.

Primary outcomes:
measure: Change in the Eyberg Child Behavior Inventory (ECBI) score at different time points (from baseline up to 12 weeks).
timeFrame: From baseline to the end of treatment at 12 weeks.
Secondary outcomes:
measure: Change in the Social Competence Scale-Parent (SCS-P) score at different time points (from baseline up to 12 weeks).
timeFrame: From baseline to the end of treatment at 12 weeks.
measure: Change in the Kidscreen-10 score at different time points (from baseline up to 12 weeks).
timeFrame: From baseline to the end of treatment at 12 weeks.
measure: Change in Strengths and Difficulties Questionnaire (SDQ) score at different time points (from baseline up to 12 weeks).
timeFrame: From baseline to the end of treatment at 12 weeks.
measure: Change in the Parenting and Family Adjustment Scales (PAFAS) score at different time points (from baseline up to 12 weeks).
timeFrame: From baseline to the end of treatment at 12 weeks.
measure: Change in the Parent Stress Scale (PSS) scores at different time points (from baseline up to 12 weeks).
timeFrame: From baseline to the end of treatment at 12 weeks.
measure: Change in the Parent Cognition Scale (PCS) score at different time points (from baseline up to 12 weeks).
timeFrame: From baseline to the end of treatment at 12 weeks.
measure: Change in the Me as parent - Short form (MaaPs-SF) score at different time points (from baseline up to 12 weeks).
timeFrame: From baseline to the end of treatment at 12 weeks.
measure: Change in the Parental Emotion Regulation Inventory (PERI-2) score at different time points (from baseline up to 12 weeks).
timeFrame: From baseline to the end of treatment at 12 weeks.
Other outcomes:
measure: Change in Eyberg Child Behavioral Inventory (ECBI) score from post-intervention to three months follow up.
timeFrame: From post-treatment to three months post intervention.
measure: Change in the Social Competence Scale-Parent (SCS-P) score from post-intervention to three months follow up.
timeFrame: From post-treatment to three months post intervention.
measure: Change in Kidscreen-10 score from post-intervention to three months follow up.
timeFrame: From post-treatment to three months post intervention.
measure: Change in Strengths and Difficulties Questionnaire (SDQ) score from post-intervention to three months follow up.
timeFrame: From post-treatment to three months post intervention.
measure: Change in the Parenting and Family Adjustment Scales (PAFAS) from post-intervention to three months follow up.
timeFrame: From post-treatment to three months post intervention.
measure: Change in the Parent Stress Scale (PSS) from post-intervention to three months follow up.
timeFrame: From post-treatment to three months post intervention.
measure: Change in the Parent Cognition Scale (PCS) score from post-intervention to three months follow up.
timeFrame: From post-treatment to three months post intervention.
measure: Change in the Me as parent - Short form (MaaPs-SF) score from post intervention to three months follow up.
timeFrame: From post-treatment to three months post intervention.
measure: Change in the Parental Emotion Regulation Inventory (PERI-2) from post intervention to three months follow up.
timeFrame: From post-treatment to three months post intervention.
Locations:
city: Bergen
country: Norway
facility: Haukeland university hospital, department of mental health care for children and adolescents
Study officials:
affiliation: UiT The Arctic University of Norway
name: Lene-Mari P. Rasmussen, Ph.d
role: PRINCIPAL_INVESTIGATOR
References: