NCT03040895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
666

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

5.2 years

First QC Date

January 30, 2017

Last Update Submit

March 24, 2023

Conditions

Keywords

Parenting practices

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • 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

  • Change in the parent- child relationship. Measurement: Child-parent relationship scale (CPRS)

    Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline

  • Change in the child's psychosocial functioning. Measurement:Strength and Difficulties Questionnaire (SDQ)

    Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline

  • 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

Study Arms (2)

ICDP-intervention for caregivers

EXPERIMENTAL

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

Treatment as usual

OTHER

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

Interventions

Group-based ICDP-intervention for caregivers through a sequence of eight meetings

ICDP-intervention for caregivers

Treatment as usual through the data collection period (6 months)

Treatment as usual

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not having children between 0-18 years
  • Insufficient Norwegian language skills
  • ICDP imposed by resolution in the Fylkesnemnda

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Institute of Public Health

Oslo, PO Box 4404, N-0403 Oslo, Norway

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Gun-Mette B. Røsand, PhD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 2, 2017

Study Start

February 10, 2016

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations