ParentingICDP RCTNCT03040895
Effect Evaluation of The International Child Development Programme (ICDP)
A study testing Group-based ICDP-intervention and Treatment as usual in people with Parenting and Parent-Child Relations, run by Norwegian Institute of Public Health at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parenting, Parent-Child Relations, Child Development
- What is being tested?
- Group-based ICDP-intervention and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 1 siteNorway
- Study dates
- 10 Feb 2016to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not having children between 0-18 years
- Insufficient Norwegian language skills
- ICDP imposed by resolution in the Fylkesnemnda
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian Institute of Public Health
Oslo, PO Box 4404, N-0403 Oslo
About this study
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.
Read the 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.
- Conditions
- Parenting, Parent-Child Relations, Child Development
- Being tested
- Group-based ICDP-intervention, Treatment as usual
- Keywords
- Parenting practices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based ICDP-interventionOther
Group-based ICDP-intervention for caregivers through a sequence of eight meetings
Treatment as usualOther
Treatment as usual through the data collection period (6 months)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parents' reactions to children's emotions. Measurement: Coping With Toddlers'/Children's Negative Emotions Scale (CTNES/CCNES)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Closeness and conflicts
Measured: 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)
Emotional symptoms, hyperactivity, conduct problems, peer problems, prosocial behavior
Measured: 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)
Measured: Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start10 Feb 2016
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- The Norwegian Directorate for Children, Youth and Family Affairs
- Responsible party
- Sponsor
- Investigators
- Gun-Mette B. Røsand, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040895
- Sponsor's protocol ID
- Public 360-nr. 16/13557
- Acronym
- ICDP RCT
- Status last verified
- Mar 2023
- First submitted
- 30 Jan 2017
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Evaluation of The International Child Development Programme (ICDP)
- ClinicalTrials.gov ID
- NCT03040895
- Acronym / sponsor ID
- ICDP RCT / Public 360-nr. 16/13557
- Conditions
- Parenting, Parent-Child Relations, Child Development
- Keywords
- Parenting practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- The Norwegian Directorate for Children, Youth and Family Affairs
- Study start
- 10 Feb 2016 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICDP-intervention for caregivers | Experimental | Other: Group-based ICDP-interventionGroup-based ICDP-intervention for caregivers through a sequence of eight meetings. The groups are led by facilitators trained in the ICDP. |
| Treatment as usual | Other | Other: Treatment as usualParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Not having children between 0-18 years
- Insufficient Norwegian language skills
- ICDP imposed by resolution in the Fylkesnemnda
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based ICDP-interventionGroup-based ICDP-intervention for caregivers through a sequence of eight meetings | Other | ICDP-intervention for caregivers |
| Treatment as usualTreatment as usual through the data collection period (6 months) | Other | Treatment as usual |
Primary outcome
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
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
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gun-Mette B. Røsand, PhD principal investigator
Norwegian Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based ICDP-intervention and Treatment as usual in people with Parenting and Parent-Child Relations, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.