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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03040895
Other study ID # Public 360-nr. 16/13557
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2016
Est. completion date May 1, 2021

Study information

Verified date March 2023
Source Norwegian Institute of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluate if a parental guidance programme based on the International Child Development Programme (ICDP) offered to the general Norwegian population, has an effect on caregivers, the relationship between caregiver and child, and on children's Development.


Description:

The International Child Development Programme (ICDP) is a psychosocial preventive programme offered to parents and other caregivers. The programme aims to improve parenting practices and thereby child development and well-being. The ICDP is designed to influence and improve the quality of contact and relation between the caregivers, usually parents, and their children through the practical application of eight themes or guidelines for positive interaction. ICDP courses are implemented in a group format and include group discussions, caregiver assignments, and report back through a sequence of eight meetings. The caregiver groups are led by facilitators trained in the ICDP, and with the competence to lead such groups. The aim of this study is to evaluate if ICDP has an effect on caregiver's positive involvement and sensitivity to childrens emotions, and on parental self-efficacy. The study will also evaluate the effect of ICDP on caregiver-child relationships, and the children's development and well-being. The study will use a stratified cluster randomized control design, and will be implemented in regular clinical practice in Norway. More knowledge within this field is important for practitioners as well as policy makers in planning preventive interventions for caregivers ant their children.


Recruitment information / eligibility

Status Completed
Enrollment 666
Est. completion date May 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Caregivers with children between the age of 0-18 years, from the general Norwegian population - Participants must be able to speak and write adequately Norwegian Exclusion Criteria: - Not having children between 0-18 years - Insufficient Norwegian language skills - ICDP imposed by resolution in the Fylkesnemnda

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Group-based ICDP-intervention
Group-based ICDP-intervention for caregivers through a sequence of eight meetings
Treatment as usual
Treatment as usual through the data collection period (6 months)

Locations

Country Name City State
Norway Norwegian Institute of Public Health Oslo

Sponsors (2)

Lead Sponsor Collaborator
Norwegian Institute of Public Health Norwegian Directorate for Children, Youth and Family Affairs

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in parents' reactions to children's emotions. Measurement: Coping With Toddlers'/Children's Negative Emotions Scale (CTNES/CCNES) Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
Primary Change in positive Involvement with children. Measurement used: Alabama Parenting Questionnaire (APQ) Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
Primary Change in Parenting self-efficacy. Measurement: Tool to measure Parenting Self Efficacy (TOPSE) Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
Secondary Change in inter-parental conflict over child rearing issues. Measurement: Parenting Problem Checklist (PPC) Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
Secondary Change in the parent- child relationship. Measurement: Child-parent relationship scale (CPRS) Closeness and conflicts Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
Secondary Change in the child's psychosocial functioning. Measurement:Strength and Difficulties Questionnaire (SDQ) Emotional symptoms, hyperactivity, conduct problems, peer problems, prosocial behavior Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
Secondary Change in the child's quality of life. Measurement: KINDer und Jugendliche zur Erfassung der gesundheitsbezogenen Lebensqualität (KINDL) Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
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