Psychosocial FunctioningNCT00862147
Effectiveness Study of the International Child Development Program
A study testing ICDP and Treatment as usual in people with Psychosocial Functioning and Child Development, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The objective of this study is to evaluate the effect of the International Child Development Program (ICDP). Research questions to be answered: 1. Does the ICDP affect children's psychosocial functioning compared to treatment as usual? 2. Does the ICDP change parent-child interaction? Read more about this study
- Who is it for?
- Ages 4 to 4 years
- Conditions the study is for
- Psychosocial Functioning, Child Development
- What is being tested?
- ICDP and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2007to Sep 2009
- 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 4 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- SDQ >/= 9, subjective treatment need
Who cannot join
- Already in treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the International Child Development Program - A Randomised Controlled Trial
The objective of this study is to evaluate the effect of the International Child Development Program (ICDP). Research questions to be answered:
- Does the ICDP affect children's psychosocial functioning compared to treatment as usual?
- Does the ICDP change parent-child interaction?
- Conditions
- Psychosocial Functioning, Child Development
- Being tested
- ICDP, Treatment as usual
- Keywords
- Child psychosocial Functioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICDPBehavioural
Also called International Child Development Program
Parent training group
Treatment as usualBehavioural
Parent and/or child focused interventions
| Study group | Role | What they receive |
|---|---|---|
| ICDP | Experimental | International Child Development Program Receives: Behavioral: ICDP |
| Treatment as usual | Active comparator | Treatment as usual Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychosocial functioning
Measured: study terminated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startJan 2007
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: the study was stopped due to failure to recruit sufficient participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial FunctioningStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Lars Wichstrom, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862147
- Sponsor's protocol ID
- 4.2006.2381
- Status last verified
- Feb 2017
- First submitted
- 13 Mar 2009
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the International Child Development Program - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00862147
- Acronym / sponsor ID
- 4.2006.2381
- Conditions
- Psychosocial Functioning, Child Development
- Keywords
- Child psychosocial Functioning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study was stopped due to failure to recruit sufficient participants
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Jan 2007 (actual)
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Mar 2009 (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.
The objective of this study is to evaluate the effect of the International Child Development Program (ICDP). Research questions to be answered:
- Does the ICDP affect children's psychosocial functioning compared to treatment as usual?
- Does the ICDP change parent-child interaction?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICDP | Experimental | Behavioral: ICDPInternational Child Development Program |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 4 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- SDQ >/= 9, subjective treatment need
Key exclusion criteria (1 listed)
- Already in treatment
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 |
|---|---|---|
| ICDPAlso: International Child Development ProgramParent training group | Behavioural | ICDP |
| Treatment as usualParent and/or child focused interventions | Behavioural | Treatment as usual |
Primary outcome
psychosocial functioning
Time frame: study terminated
Results and safety
The study was stopped early (reason given: the study was stopped due to failure to recruit sufficient participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
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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.
Lars Wichstrom principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICDP and Treatment as usual in people with Psychosocial Functioning and Child Development, run by Norwegian University of Science and Technology 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 14 Feb 2017. 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 was stopped early (reason given: the study was stopped due to failure to recruit sufficient participants). Results are not available in the source record.
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?
psychosocial functioning (time frame: study terminated). 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 14 Feb 2017.