About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Intervention
BehavioralThe intervention group will receive Invest in Play (iiP), a 12 session group-based parent program, which is led by two trained group leaders.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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.
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.
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.
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.
Sponsors and contacts
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University of Tromso
Lead sponsor
NORCE Norwegian Research Centre AS
Collaborator
Norwegian University of Science and Technology
Collaborator