Learning ProblemsNCT02217072
Educational Support Interventions for Children in Care
A study testing School intervention and Parents as Tutors in people with Learning Problems, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.
Trial summary
A Randomized controlled study of two different educational support interventions developed for children in foster care (age 6-13). Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Learning Problems
- What is being tested?
- School intervention and Parents as Tutors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Dec 2017
- 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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 6-13
- fostercare placement
- placement in a participating municipality
Who cannot join
- persuasive developmental disorders
- special education students
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
SFI - The Danish National Centre for Social Research
Copenhagen, 1052
Misja Eiberg, 33480819, mei@sfi.dk
Helle Hansen, +45 33480927, heh@sfi.dk
About this study
Official title: A Randomized Controlled Trial of Educational Support Interventions for Children in Care
A Randomized controlled study of two different educational support interventions developed for children in foster care (age 6-13).
Read the detailed description
A Randomized controlled study of two different educational support interventions developed for children in foster care (age 6-13). One intervention is school-based and involves a team of professionals at the child's school, and the other is a home-based tutoring intervention provided by the foster parents. The participants in the study are assigned to three groups (the two intervention groups and control group). Based on power calculation we aim to recruit approximately 180-200 foster children, their foster parents and public schools to participate in the study.
- Conditions
- Learning Problems
- Being tested
- School intervention, Parents as Tutors
- Keywords
- academic performance, cognitive development, children in care, prevention of school failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School interventionBehavioural
A school-based intervention that builds on the promising Swedish programme SkolFam, but is adapted to a Danish school context. The two main components of the programme are a) comprehensive assessment of the child, involving testing of the child's cognitive and academic abilities and difficulties as well as an evaluation of the child's behaviour, school-related social relations and well-being, and b) a systematic and individually targeted intervention plan, made in collaboration between a psychologist, the teachers, and a special educational teacher at the school (e.g., the reading counsellor).
Parents as TutorsBehavioural
A home-based intervention, comprising a structured tutoring programme that allows foster parents to systematically support the foster child's school performance. Foster parents will attend an introductory tutor training seminar at which they will be introduced to relevant theory on learning and counselled on tutoring practice. The intervention itself is designed to provide approximately three hours per week of individual home-based tutoring for a period of 40 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control |
| Parents as Tutors | Experimental | Educational support intervention Receives: Behavioral: Parents as Tutors |
| school intervention | Experimental | Educational support intervention Receives: Behavioral: School intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Academic performance
Reading test and mathematical test
Measured: 17 months after intervention start
Secondary outcomes (1)
Cognitive functions
Wechsler Intelligence Scale for Children IV and Contingency Naming Test
Measured: 17 months after intervention start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning ProblemsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VIVE - The Danish Center for Social Science Research
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Social Affairs
- Responsible party
- Sponsor
- Investigators
- Misja Eiberg, Ph.d. fellow, Principal investigator, SFI - The Danish National Centre for Social Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217072
- Sponsor's protocol ID
- SFI 2691
- Status last verified
- Aug 2014
- First submitted
- 28 Jul 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Educational Support Interventions for Children in Care
- ClinicalTrials.gov ID
- NCT02217072
- Acronym / sponsor ID
- SFI 2691
- Conditions
- Learning Problems
- Keywords
- academic performance, cognitive development, children in care, prevention of school failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- VIVE - The Danish Center for Social Science ResearchUniversity, hospital or other
- Collaborators
- Ministry of Social Affairs
- Study start
- Sep 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Aug 2014 (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.
A Randomized controlled study of two different educational support interventions developed for children in foster care (age 6-13).
Detailed description
A Randomized controlled study of two different educational support interventions developed for children in foster care (age 6-13). One intervention is school-based and involves a team of professionals at the child's school, and the other is a home-based tutoring intervention provided by the foster parents. The participants in the study are assigned to three groups (the two intervention groups and control group). Based on power calculation we aim to recruit approximately 180-200 foster children, their foster parents and public schools to participate in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control |
| Parents as Tutors | Experimental | Behavioral: Parents as TutorsEducational support intervention |
| school intervention | Experimental | Behavioral: School interventionEducational support intervention |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age 6-13
- fostercare placement
- placement in a participating municipality
Key exclusion criteria (2 listed)
- persuasive developmental disorders
- special education students
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 |
|---|---|---|
| School interventionA school-based intervention that builds on the promising Swedish programme SkolFam, but is adapted to a Danish school context. The two main components of the programme are a) comprehensive assessment of the child, involving testing of the child's cognitive and academic abilities and difficulties as well as an evaluation of the child's behaviour, school-related social relations and well-being, and b) a systematic and individually targeted intervention plan, made in collaboration between a psychologist, the teachers, and a special educational teacher at the school (e.g., the reading counsellor). | Behavioural | school intervention |
| Parents as TutorsA home-based intervention, comprising a structured tutoring programme that allows foster parents to systematically support the foster child's school performance. Foster parents will attend an introductory tutor training seminar at which they will be introduced to relevant theory on learning and counselled on tutoring practice. The intervention itself is designed to provide approximately three hours per week of individual home-based tutoring for a period of 40 weeks. | Behavioural | Parents as Tutors |
Primary outcome
Academic performance
Time frame: 17 months after intervention start
Reading test and mathematical test
1 secondary outcome
Cognitive functions
Time frame: 17 months after intervention start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
Related trials for Learning Problems
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Recruiting
Online Feeding Education for Fathers of Children With Feeding Problems
Feeding Problems, Parent Training
Not yet recruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Recruiting
Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation
Mental Health, Parenting / Maternal Behavior
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
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.
Misja Eiberg, Ph.d. fellow principal investigator
SFI - The Danish National Centre for Social Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School intervention and Parents as Tutors in people with Learning Problems, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Aug 2014. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Misja Eiberg (+45 33480819, mei@sfi.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Academic performance (time frame: 17 months after intervention start). 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 15 Aug 2014.