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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change in the Eyberg Child Behavior Inventory (ECBI) score at different time points (from baseline up to 12 weeks). [Срок оценки: From baseline to the end of treatment at 12 weeks.]

Вторичные конечные точки (8)

• Change in the Social Competence Scale-Parent (SCS-P) score at different time points (from baseline up to 12 weeks). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: From baseline to the end of treatment at 12 weeks.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

\- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Норвегия · 5 центров

• Betanien Hospital — Bergen
• Haukeland university hospital, department of mental health care for children and adolescen — Bergen
• Helse Fonna HF, BUP Stord — Haugesund
• Helse Nord-Trøndelag HF, Barne- og ungdomspsykiatrisk avdeling (BUP) — Namsos
• OUS/PHA/BUPA/BUP Oslo Nord — Oslo

Идентификаторы

NCT: NCT06984809 · 2024/785387 · 2025-957314

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗