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Effect Evaluation of The International Child Development Programme (ICDP) (ICDP RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040895
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
The Norwegian Directorate for Children, Youth and Family Affairs
Information provided by (Responsible Party):
Norwegian Institute of Public Health

Brief 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.

Condition or disease Intervention/treatment Phase
Parenting Parent-Child Relations Child Development Other: Group-based ICDP-intervention Other: Treatment as usual Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect Evaluation of The International Child Development Programme (ICDP)
Actual Study Start Date : February 10, 2016
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : February 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ICDP-intervention for caregivers
Group-based ICDP-intervention for caregivers through a sequence of eight meetings. The groups are led by facilitators trained in the ICDP.
Other: Group-based ICDP-intervention
Group-based ICDP-intervention for caregivers through a sequence of eight meetings

Treatment as usual
Participants may use other health services (GP, other interventions) as usual through the data Collection period (6 months). Afther this period, they will have the opportunity to join an ICDP-Group if they still want.
Other: Treatment as usual
Treatment as usual through the data collection period (6 months)




Primary Outcome Measures :
  1. Change in parents' reactions to children's emotions. Measurement: Coping With Toddlers'/Children's Negative Emotions Scale (CTNES/CCNES) [ Time Frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline ]
  2. Change in positive Involvement with children. Measurement used: Alabama Parenting Questionnaire (APQ) [ Time Frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline ]
  3. Change in Parenting self-efficacy. Measurement: Tool to measure Parenting Self Efficacy (TOPSE) [ Time Frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline ]

Secondary Outcome Measures :
  1. Change in inter-parental conflict over child rearing issues. Measurement: Parenting Problem Checklist (PPC) [ Time Frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline ]
  2. Change in the parent- child relationship. Measurement: Child-parent relationship scale (CPRS) [ Time Frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline ]
    Closeness and conflicts

  3. Change in the child's psychosocial functioning. Measurement:Strength and Difficulties Questionnaire (SDQ) [ Time Frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline ]
    Emotional symptoms, hyperactivity, conduct problems, peer problems, prosocial behavior

  4. Change in the child's quality of life. Measurement: KINDer und Jugendliche zur Erfassung der gesundheitsbezogenen Lebensqualität (KINDL) [ Time Frame: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040895


Contacts
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Contact: Gun-Mette B. Røsand, PhD +47 21078085 gbro@fhi.no
Contact: Heidi Aase +47 21078344 Heidi.Aase@fhi.no

Locations
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Norway
Norwegian Institute of Public Health Recruiting
Oslo, Norway, PO Box 4404, N-0403 Oslo
Contact: Gun-Mette B. Røsand, PhD    +47 21078085    gbro@fhi.no   
Contact: Heidi Aase, PhD    +4721078344    Heidi.Aase@fhi.no   
Principal Investigator: Gun-Mette B. Røsand, PhD         
Sub-Investigator: Heidi Aase, PhD         
Sub-Investigator: Leif Edvard Aarø, Dr. Philos         
Sub-Investigator: Robert Smith, PdD         
Sub-Investigator: Espen Røysamb, Dr. psychol         
Sub-Investigator: Maren S. Helland, PhD         
Sub-Investigator: Nima Wesseltoft-Rao, PhD         
Sponsors and Collaborators
Norwegian Institute of Public Health
The Norwegian Directorate for Children, Youth and Family Affairs
Investigators
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Principal Investigator: Gun-Mette B. Røsand, PhD Norwegian Institute of Public Health
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Responsible Party: Norwegian Institute of Public Health
ClinicalTrials.gov Identifier: NCT03040895    
Other Study ID Numbers: Public 360-nr. 16/13557
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian Institute of Public Health:
Parenting practices