Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT06315036 - Effects of Developmental Gymnastics on Preschoolers' Motor Skills N/A
Active, not recruiting NCT05143294 - Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT05267730 - Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT03680157 - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed NCT00362076 - The Role of Motion in Infants' Ability to Categorize N/A
Recruiting NCT05525962 - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Completed NCT03232606 - Physical Activity of Asthmatic Children
Completed NCT05955755 - The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear N/A
Recruiting NCT04443855 - WASH Benefits Child Development Follow up N/A
Not yet recruiting NCT06335524 - Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants N/A
Not yet recruiting NCT05783141 - Prebiotic Effects in Healthy Toddlers N/A
Completed NCT02800616 - The Healthy Elementary School of the Future N/A
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Completed NCT02539251 - Arabic Ages and Stages Questionnaire-III
Completed NCT02242539 - Tools to Improve Parental Recognition of Developmental Deficits in Children N/A
Completed NCT03010306 - CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru N/A
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT00989859 - Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
Recruiting NCT00980733 - Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits Phase 3
Terminated NCT04347707 - Building Regulation in Dual Generations N/A