Condition category
Not Applicable
Date applied
14/09/2017
Date assigned
18/09/2017
Last edited
22/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A disproportionately high number of children in families receiving support from Child Welfare Services (CWS) end up marginalized from society in adulthood. For many of these children, a strong contributing factor to their poor outcomes is academic failure. These are also widespread issues internationally. The researchers have developed an intervention called Enhanced Academic Support (EAS) for children at risk of academic failure. The aim of this study is to assess the effectiveness of the intervention with three municipal CWS agencies in Norway.

Who can participate?
Children aged 6 to13 (primary school grades) and their parents

What does the study involve?
Participating families are randomly allocated to one of two groups. One group receives the EAS intervention from a trained practitioner in six home-visits with support between visits over a period of 6 months. The other (control) group receives regular child welfare support from a practitioner who has not been trained in EAS. Business as usual includes advice and guidance, parent training, financial aid and parent relief. Participating children and parents are assessed before the intervention starts, after the intervention has ended (after about 6 months) and again 6 months later.

What are the possible benefits and risks of participating?
Participation in the study can increase parents', teachers' and child welfare staff’s awareness of the participating children’s academic strengths and needs. The intervention can potentially prevent gaps in the curriculum, and improve children's learning, their homework routines, and their parents' involvement in school. Participating children might not feel motivated to receive academic support if they believe it to be unnecessary. Participants in the control group risk not receiving the intervention after the study period, as the intervention is contingent upon the family still being child welfare recipients. Participating families who are allocated to the control group might feel disappointment.

Where is the study run from?
The Regional Centre for Child and Adolescent Mental Health (Norway)

When is the study starting and how long is it expected to run for?
September 2017 to September 2019

Who is funding the study?
1. The Norwegian Research Council
2. The Regional Centre for Child and Adolescent Mental Health in Norway (RBUP)
3. The Norwegian Center for Child Behavioral Development (NUBU)

Who is the main contact?
Dr Kristine A Hagen

Trial website

http://www.skolestøtte.no

Contact information

Type

Scientific

Primary contact

Dr Kristine Amlund Hagen

ORCID ID

Contact details

Norwegian Center for Child Behavioral Development
Postboks 7053 Majorstuen
Oslo
0306
Norway

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

230009

Study information

Scientific title

Implementation and evaluation of enhanced academic support to improve educational outcomes for children in child welfare

Acronym

KTCW/KOBA

Study hypothesis

1. Integrated Knowledge Translation will be a useful strategy to develop and successfully implement Enhanced Academic Support in Child Welfare Services
2. Enhanced academic support delivered by child welfare practitioners to children and families will improve children's educational achievement and parental involvement in school

Ethics approval

Norwegian Centre for Research Data (NSD), 27/10/2016, ref: 47161

Study design

Multi-centre hybrid type 2 individually randomized controlled intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Education for children in families receiving support from Child Welfare services

Intervention

The method of randomization is block randomization with a block size of ten. A computer software (confirmit) generates a random numbers table-approach to assign random numbers to participants within blocks. Randomization is done site-wise.

Each family enrolled in the study will be randomized to either receive the EAS intervention from a practitioner trained in the intervention or receive regular child welfare support from a practitioner who has not been trained in EAS.

1. The experimental intervention is Enhanced Academic Support, which is a flexible and locally tailored research supported intervention delivered in-home to families in Child Welfare by Child Welfare practitioners in addition to the help or care the families already receive. Enhanced Academic Support is based on common elements of effective community- and home-based interventions to improve educational attainment for children at risk of failing in school. It includes guidance in positive parental involvement, academic training with direct instruction in reading and math, guidance in structure and routines for homework, and guidance in positive reinforcement, praise and correctional feedback.
2. The comparison condition is business as usual in Norwegian Child Welfare services, which includes a variety of measures such as advice and guidance, parent training, financial aid, parent relief etc.

Participating children and parents will be assessed before the intervention starts, after the intervention has concluded (approximately after six months) and again six months later.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Primary outcome measure as of 22/10/2018:
Primary effectiveness outcomes:
1. Children's reading abilities, assessed using the Oral Reading Fluency Test, Arnesen et al., 2016
2. Children's mathematical abilities, assessed using Regnefaktaprøven, Lesesenteret
3. Parental involvement in school, assessed using Parent and School Survey, Ringenberg et al., 2005
Assessed pre-intervention, post-intervention (after 6 months) and at follow up (after 12 months) in the families homes by trained interviewers

Primary implementation outcomes are indexed by intervention specific fidelity-checklists measuring:
1. Adherence to core intervention components and competence in delivery
2. Parent comprehension of core components
3. User involvement and satisfaction with delivery of intervention components
Checklists are completed by child welfare practitioners using smartphones after each intervention session, and by parents answering the same questions in telephone interviews after each intervention session. Checklists include:
1. Acceptability of Intervention Measure (AIM, Weiner et al., 2018)
2. Intervention Appropriateness Measure (IAM, Weiner et al., 2018)
3. Feasibility of Intervention Measure (FIM, Weiner et al., 2018)

Previous primary outcome measure:
Primary effectiveness outcomes:
1. Children's reading abilities, assessed using the Oral Reading Fluency Test, Arnesen et al., 2016
2. Children's mathematical abilities, assessed using Regnefaktaprøven, Lesesenteret
3. Parental involvement in school, assessed using Parent and School Survey, Ringenberg et al., 2005
Assessed pre-intervention, post-intervention (after 6 months) and at follow up (after 12 months) in the families homes by trained interviewers

Primary implementation outcomes are indexed by intervention specific fidelity-checklists measuring:
1. Adherence to core intervention components and competence in delivery
2. Parent comprehension of core components
3. User involvement and satisfaction with delivery of intervention components
Checklists are completed by child welfare practitioners using smartphones after each intervention session, and by parents answering the same questions in telephone interviews after each intervention session

Secondary outcome measures

Secondary implementation measures:
1. Organizational readiness for change, assessed using unpublished questionnaire made by study authors, administered pre and post intervention
2. Organizational climate for implementing evidence based practice, assessed using Implementation Climate Scale, Aarons & Ehrhart, administered pre and post intervention
3. Practitioner's perceived competence in providing academic support, assessed using unpublished questionnaire made by study authors, administered pre and post intervention
4. Satisfaction with implementation process and intervention, assessed using focus groups with practitioners and collaborators conducted post intervention

Secondary effectiveness measures and covariates, administered pre, post and follow up:
1. Child mental health, assessed using Strengths and Difficulties Questionnaire, Goodman
2. Social skills, assessed using Social Skills Rating System, Gresham & Elliot
3. Executive functions, assessed Five to Fifteen, Kadesjö et al.

Semi-structured interviews are also conducted with participating families after the intervention to learn more about their experiences with the intervention.

Overall trial start date

08/09/2017

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Children in families receiving services from municipal Child Welfare Services
2. Children (boys and girls) in 1st to 7th grade and their parents/caregivers
Consent, assent and the questionnaires will be available in Norwegian, English, Arabic, and Somali. The study also includes practitioners at local child welfare services in and around Oslo, Norway

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

120-150

Participant exclusion criteria

1. Developmental disability
2. Parents not able to give informed consent due to language restriction (not able to understand Norwegian, English, Arabic or Somali)

Recruitment start date

08/09/2017

Recruitment end date

30/06/2019

Locations

Countries of recruitment

Norway

Trial participating centre

Bjerke Barneverntjeneste
Oslo
0580
Norway

Trial participating centre

Drammen barneverntjeneste
Drammen
3008
Norway

Trial participating centre

Baerum barneverntjeneste
1346 gjettum
Norway

Sponsor information

Organisation

The Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway

Sponsor details

Gullhaugveien 1-3
Oslo
0484
Norway
+47 (0)22 58 60 00
post@r-bup.no

Sponsor type

Research organisation

Website

www.r-bup.no

Funders

Funder type

Research council

Funder name

Norges Forskningsråd

Alternative name(s)

Research Council of Norway, Forskningsrådet, Norwegian Research Council

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Norway

Funder name

Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Norwegian Center for Child Behavioral Development

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists plan to publish or add a protocol, including a statistical analysis plan, by the end of 2017. Results from this project will be presented at both national and international conferences, used to raise public awareness about the school situation for children in the CWS, used for educational purposes and published in peer reviewed and scientific journals. It is anticipated that the first results will published in January 2020.

IPD sharing statement
The datasets generated and analyzed during the current study will be included in subsequent results publications. Parts of the datasets generated during the current study will be available upon request after 2020 from Kristine Amlund Hagen, PI (kah@r-bup.no). Requests for datasets will be considered by the research team at RBUP. Criteria for granting access to data include non-interference with the planned publications of the PhD and post doc fellows or any other plans for publications from the research team, and that members of the research team are co-authors on all publications of data from this study. Requests will be considered on a case by case basis.

Intention to publish date

01/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/10/2018: The following changes were made: 1. The recruitment end date was updated from 08/09/2018 to 30/06/2019. 2. The overall trial end date was updated from 08/09/2019 to 30/06/2020. 3. The intention to publish date was updated from 01/01/2020 to 01/12/2020. 4. The primary outcome measure was updated.