RehabilitationCICINCT04798859
The Child in Context Intervention Study
A study testing Family centered in-home rehabilitation in people with Rehabilitation and Brain Injuries, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
Trial summary
Children with acquired brain injury (ABI) often struggle with complex impairments, including cognitive (such as memory and attention), social, emotional and behavioral challenges. There is a lack of evidence-based knowledge about rehabilitation for children with ABI in the chronic phase. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Rehabilitation, Brain Injuries, Brain Injury, Chronic
- What is being tested?
- Family centered in-home rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteNorway
- Study dates
- 10 May 2021to 6 Dec 2023
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- School-aged (6-16 years) children with clinical ABI-diagnosis and CT/MRI verified injury-related intracranial abnormalities, 1 year or more after injury. We anticipate including patients with the following etiologies: Traumatic brain injury (TBI), cerebrovascular incidents, anoxia, encephalitis and non-progressive brain tumors.
- The above-mentioned children, and/or their parents, report ABI-related cognitive, emotional, or behavioral problems that affect participation in activities with family, friends, school and/or community.
- The children attend school regularly, with or without injury-related adaptations.
- The family is able to actively participate in a goal-oriented approach, this includes speaking sufficiently Norwegian. An exception can be made for parents who speak English but are able to understand and read Norwegian.
Who cannot join
- Patients with severe pre- or comorbid neurological or neuropsychiatric disorders that would confound assessment and/or treatment outcomes.
- Patients with brain tumors in active treatment or at great risk of relapse (i.e., unstable condition).
- Patients with severe psychiatric illness or children with injuries so severe that they are in institutionalized care most of the time.
- Parental severe psychiatric illness, drug abuse or indications of a history of or risk of domestic violence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating Chronic Symptoms of Pediatric Acquired Brain Injury - The Child In Context Intervention Study
Children with acquired brain injury (ABI) often struggle with complex impairments, including cognitive (such as memory and attention), social, emotional and behavioral challenges. There is a lack of evidence-based knowledge about rehabilitation for children with ABI in the chronic phase. The current study, the CICI Study, is a randomized controlled trial (RCT) directed towards children with ABI and their families in the chronic phase.
The study will be conducted in close collaboration with schools and local health care providers. The CICI Study focuses on the child's and parents' individually identified target outcome areas and rehabilitation goals. The intervention aims to enhance everyday functioning in the home and school environment by attaining rehabilitation goals in areas noted as challenging by the participants. The efficacy of the CICI-intervention will be measured in terms of goal attainment, burden of brain injury related symptoms, parenting self-efficacy, unmet health care needs, as well as several aspects of child, parent and family functioning.
Read the detailed description
There is considerable knowledge about how to help children with ABI during the first, acute and post-acute stages. Yet, impairments are often long lasting and, due to the vulnerability of children's developing brain, new problems may emerge or become increasingly problematic over time. Children with ABI may struggle at school and with peers, which can lead to or increase emotional difficulties, and reduce quality of life, affecting the children and their families. The local communities and the children's schools are, together with the families, often left responsible for dealing with the chronic challenges of pABI. Parents may experience considerable stress and develop emotional symptoms when a child suffers an ABI. As a result, the entire family may experience impaired functioning, which in turn may affect the long-term prognosis of the child with ABI.
Eighty families will be included in the study: 40 in the intervention group and 40 in the control group. The children will have a clinical ABI diagnosis, verified injury related intracranial abnormalities, and be at least one year post injury at inclusion. The children and/or their families must report enduring cognitive, emotional, social or physical challenges related to the brain injury. The intervention will be conducted in collaboration with the children's families, schools and their local health care providers. It consists of individualized goal-oriented strategies adapted to the home- and school-setting. Goal attainment scaling will be applied. In addition, psychoeducation will be provided to the family and school/local care providers on topics related to the child's injury. A parent group session will be held for discussions and knowledge transfer concerning family challenges after pABI, such as communication skills and parenting. The intervention will include 7 individualized meetings with the family (7 sessions whereof most will be videoconferences, but with the possibility of 1-2 of the sessions being home visits), one parent group seminar and 4 sessions with school and local health care providers during a period of 4-5 months.
Assessments will be conducted at baseline (T1), at the end of the intervention (T2, 4-5 months after inclusion) and one year after inclusion (T3). Baseline assessment includes a brief neuropsychological assessment of the children in addition to the outcome measures at T2 and T3. Outcome assessors will ble blinded to group allocation. Primary outcomes are change in parent-reported brain injury symptoms of the children and change in parenting self-efficacy. Secondary outcomes include change in child-rated severity of brain injury symptoms, change in unmet healthcare needs of the family, change in children's executive functioning in the home and school environment as assessed by parents, children and teachers, change in children's quality of life assessed by parents and children, change in family functioning, change in caregiver emotional symptoms, an evaluation of the intervention completed by parents, children and teachers in the intervention group, change in the perceived severity of the individually defined target outcome areas completed by children and parents, and change in goal attainment scaling in the intervention group.
The findings of this study will contribute to enhanced clinical expertise within pABI-rehabilitation on a specialist health care level, and will also be relevant for a wide array of health care professionals in the community as well as the educational system and parents of children with ABI.
- Conditions
- Rehabilitation, Brain Injuries, Brain Injury, Chronic, Brain Diseases, Family, Childhood Brain Tumor
- Being tested
- Family centered in-home rehabilitation, Control
- Keywords
- Pediatric brain injury, Randomized controlled trial (RCT), School, Family health care needs, Community
- Medical subject headings
- Brain Injuries, Brain Injury, Chronic, Brain Diseases, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family centered in-home rehabilitationOther
Goal-oriented individualized intervention targeting brain injury related areas noted as challenging by the child and family
ControlOther
Usual follow-up in the municipality
| Study group | Role | What they receive |
|---|---|---|
| Family-centered in home rehabilitation | Experimental | Seven individualized meetings with the family (7 sessions whereof most will be videoconferences, with the possibility of 1-2 of the sessions being home visits), one parent group seminar and 4 meetings (three videoconferences and one phone call) with school and local care providers during a period of 4-5 months.
Based on target outcomes areas noted by children and parents, individual goals will be established (2-5 per family). Strategies to meet goals will be established for each goal, and goal attainment scaling will be used to quantify goal attainment. Receives: Other: Family centered in-home rehabilitation |
| Control group | Active comparator | Usual health care and rehabilitation services provided in the municipality, including school. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parent-reported severity of children's brain injury symptoms
Assessed with the Health and Behavior Inventory (HBI) on a scale from 0 (Never) to 3 (Often), where higher score indicates more severe symptoms.
Measured: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in parenting self-efficacy assessed with the assessment tool "Parenting Self-Efficacy (TOPSE)"
The Tool to measure Parenting Self-Efficacy (TOPSE) is rated on a scale from 0 (completely disagree) to 10 (completely agree). Higher total score on the questionnaire indicates higher parenting self-efficacy.
Measured: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Secondary outcomes (10)
Change in child-reported severity of brain injury symptoms
Assessed with the Health and Behavior Inventory (HBI) on a scale from 0 (Never) to 3 (Often), where higher score indicates more severe symptoms.
Measured: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in unmet healthcare needs of the family
Assessed with the Family Needs Questionnaire - Pediatric version - FNQ-P on a scale from 1 (the need is not at all met) to 5 (completely met). Higher total score indicates higher level of met needs.
Measured: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in children's executive functioning in the home and school environment
Assessed with the Behavior Rating Inventory of Executive Function 2 - BRIEF-2 on a 3-point scale: Never a problem, sometimes a problem or often a problem. Higher scaled score indicates higher level of problems with executive functioning.
Measured: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in the children's quality of life
Assessed with the Pediatric Quality of Life Inventory - Peds-QL scored on a scale from 0 (never a problem) to 4 (almost always a problem). Higher scaled score indicates higher quality of life.
Measured: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in family functioning
Assessed with the family Assessment Device - FAD on a 4-point scale: Strongly agree, agree, disagree and strongly disagree. Lower total scaled score represents better family functioning.
Measured: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in depressive symptoms of the parents
Assessed with the Patient Health Questionnaire 9 - PHQ-9 on a scale from 0 (not at all) to 3 (almost every day). Higher mean score reflects a higher level of depressive symptoms.
Measured: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in anxiety symptoms of the parents
Generalized Anxiety Disorder 7 - GAD-7 on a scale from from 0 (not at all) to 3 (almost every day). Higher mean score reflects a higher level of anxiety symptoms.
Measured: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Evaluation of the intervention
A custom-made evaluation questionnaire for the CICI Study will be completed by parents, children and teachers in the intervention group, as well as therapists. The Evaluation form is rated on a 5-point scale from "completely disagree" to "completely agree". Higher scaled score indicates higher degree of satisfaction.
Measured: Immediately after the intervention period (T2) (4-5 months after baseline)
Changes in the difficulty score (scale from 0 to 4) of the self- and parental perceived severity of the individually defined target outcome areas
Each of the participating family members (parent(s) and child) nominate their three most important problems (target outcome areas) and how difficult they find them on a scale from 0 (not at all difficult) to 4 (very difficult), where . changes in the difficulty scores are evaluated. A negative change indicates a decrease in perceived difficulty.
Measured: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in goal attainment scaling (GAS) in the CICI group
Goal Attainment Scaling (GAS) is assessed by GAS-scaling of individually defined goals (scale from 1 to 5). A higher positive change reflects higher level of goal attainment.
Measured: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start10 May 2021
- Primary completion8 Aug 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies 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
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Oslo University Hospital, Children's Hospital Medical Center, Cincinnati, Monash University, The Hospital of Vestfold
- Responsible party
- Sponsor
- Investigators
- Marianne Løvstad, PhD, Principal investigator, Sunnaas Rehabilitation Hospital and University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798859
- Sponsor's protocol ID
- SunnaasRH_CICI226059
- Acronym
- CICI
- Status last verified
- Nov 2022
- First submitted
- 2 Mar 2021
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rohrer-Baumgartner N, Holthe IL, Svendsen EJ, Dahl HM, Borgen IMH, Hauger SL, Brunborg C, Ponsford J, Wade SL, Egeland J, Roe C, Lovstad M. Effects of an individualized and goal-oriented intervention in the chronic phase of pediatric acquired brain injury: the Child in Context Intervention (CICI)-a randomized controlled trial. BMC Pediatr. 2026 May 21;26(1):655. doi: 10.1186/s12887-026-06997-y.
PubMed 42168942Holthe IL, Rohrer-Baumgartner NM, Svendsen EJ, Roe C, Borgen IMH, Hauger SL, Ponsford JL, Egeland J, Wade S, Lovstad M. SMART-goal domains and goal attainment in an individualized, goal-oriented intervention for children with acquired brain injury and their families. Neuropsychol Rehabil. 2025 Jul;35(6):1229-1253. doi: 10.1080/09602011.2024.2402095. Epub 2024 Sep 16.
PubMed 39283234Rohrer-Baumgartner N, Holthe IL, Svendsen EJ, Roe C, Egeland J, Borgen IMH, Hauger SL, Forslund MV, Brunborg C, Ora HP, Dahl HM, Bragstad LK, Killi EM, Sandhaug M, Kleffelgard I, Strand-Saugnes AP, Dahl-Hilstad I, Ponsford J, Winter L, Wade S, Lovstad M. Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial. Trials. 2022 Feb 22;23(1):169. doi: 10.1186/s13063-022-06048-8.
PubMed 35193666
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Chronic Symptoms of Pediatric Acquired Brain Injury - The Child In Context Intervention Study
- ClinicalTrials.gov ID
- NCT04798859
- Acronym / sponsor ID
- CICI / SunnaasRH_CICI226059
- Conditions
- Rehabilitation, Brain Injuries, Brain Injury, Chronic, Brain Diseases, Family, Childhood Brain Tumor
- Keywords
- Pediatric brain injury, Randomized controlled trial (RCT), School, Family health care needs, Community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Oslo University Hospital, Children's Hospital Medical Center, Cincinnati, Monash University, The Hospital of Vestfold
- Study start
- 10 May 2021 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 15 Mar 2021 (actual)
- 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.
Children with acquired brain injury (ABI) often struggle with complex impairments, including cognitive (such as memory and attention), social, emotional and behavioral challenges. There is a lack of evidence-based knowledge about rehabilitation for children with ABI in the chronic phase. The current study, the CICI Study, is a randomized controlled trial (RCT) directed towards children with ABI and their families in the chronic phase.
The study will be conducted in close collaboration with schools and local health care providers. The CICI Study focuses on the child's and parents' individually identified target outcome areas and rehabilitation goals. The intervention aims to enhance everyday functioning in the home and school environment by attaining rehabilitation goals in areas noted as challenging by the participants. The efficacy of the CICI-intervention will be measured in terms of goal attainment, burden of brain injury related symptoms, parenting self-efficacy, unmet health care needs, as well as several aspects of child, parent and family functioning.
Detailed description
There is considerable knowledge about how to help children with ABI during the first, acute and post-acute stages. Yet, impairments are often long lasting and, due to the vulnerability of children's developing brain, new problems may emerge or become increasingly problematic over time. Children with ABI may struggle at school and with peers, which can lead to or increase emotional difficulties, and reduce quality of life, affecting the children and their families. The local communities and the children's schools are, together with the families, often left responsible for dealing with the chronic challenges of pABI. Parents may experience considerable stress and develop emotional symptoms when a child suffers an ABI. As a result, the entire family may experience impaired functioning, which in turn may affect the long-term prognosis of the child with ABI.
Eighty families will be included in the study: 40 in the intervention group and 40 in the control group. The children will have a clinical ABI diagnosis, verified injury related intracranial abnormalities, and be at least one year post injury at inclusion. The children and/or their families must report enduring cognitive, emotional, social or physical challenges related to the brain injury. The intervention will be conducted in collaboration with the children's families, schools and their local health care providers. It consists of individualized goal-oriented strategies adapted to the home- and school-setting. Goal attainment scaling will be applied. In addition, psychoeducation will be provided to the family and school/local care providers on topics related to the child's injury. A parent group session will be held for discussions and knowledge transfer concerning family challenges after pABI, such as communication skills and parenting. The intervention will include 7 individualized meetings with the family (7 sessions whereof most will be videoconferences, but with the possibility of 1-2 of the sessions being home visits), one parent group seminar and 4 sessions with school and local health care providers during a period of 4-5 months.
Assessments will be conducted at baseline (T1), at the end of the intervention (T2, 4-5 months after inclusion) and one year after inclusion (T3). Baseline assessment includes a brief neuropsychological assessment of the children in addition to the outcome measures at T2 and T3. Outcome assessors will ble blinded to group allocation. Primary outcomes are change in parent-reported brain injury symptoms of the children and change in parenting self-efficacy. Secondary outcomes include change in child-rated severity of brain injury symptoms, change in unmet healthcare needs of the family, change in children's executive functioning in the home and school environment as assessed by parents, children and teachers, change in children's quality of life assessed by parents and children, change in family functioning, change in caregiver emotional symptoms, an evaluation of the intervention completed by parents, children and teachers in the intervention group, change in the perceived severity of the individually defined target outcome areas completed by children and parents, and change in goal attainment scaling in the intervention group.
The findings of this study will contribute to enhanced clinical expertise within pABI-rehabilitation on a specialist health care level, and will also be relevant for a wide array of health care professionals in the community as well as the educational system and parents of children with ABI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Family-centered in home rehabilitation | Experimental | Other: Family centered in-home rehabilitationSeven individualized meetings with the family (7 sessions whereof most will be videoconferences, with the possibility of 1-2 of the sessions being home visits), one parent group seminar and 4 meetings (three videoconferences and one phone call) with school and local care providers during a period of 4-5 months. Based on target outcomes areas noted by children and parents, individual goals will be established (2-5 per family). Strategies to meet goals will be established for each goal, and goal attainment scaling will be used to quantify goal attainment. |
| Control group | Active comparator | Other: ControlUsual health care and rehabilitation services provided in the municipality, including school. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- School-aged (6-16 years) children with clinical ABI-diagnosis and CT/MRI verified injury-related intracranial abnormalities, 1 year or more after injury. We anticipate including patients with the following etiologies: Traumatic brain injury (TBI), cerebrovascular incidents, anoxia, encephalitis and non-progressive brain tumors.
- The above-mentioned children, and/or their parents, report ABI-related cognitive, emotional, or behavioral problems that affect participation in activities with family, friends, school and/or community.
- The children attend school regularly, with or without injury-related adaptations.
- The family is able to actively participate in a goal-oriented approach, this includes speaking sufficiently Norwegian. An exception can be made for parents who speak English but are able to understand and read Norwegian.
Key exclusion criteria (4 listed)
- Patients with severe pre- or comorbid neurological or neuropsychiatric disorders that would confound assessment and/or treatment outcomes.
- Patients with brain tumors in active treatment or at great risk of relapse (i.e., unstable condition).
- Patients with severe psychiatric illness or children with injuries so severe that they are in institutionalized care most of the time.
- Parental severe psychiatric illness, drug abuse or indications of a history of or risk of domestic violence.
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 |
|---|---|---|
| Family centered in-home rehabilitationGoal-oriented individualized intervention targeting brain injury related areas noted as challenging by the child and family | Other | Family-centered in home rehabilitation |
| ControlUsual follow-up in the municipality | Other | Control group |
Primary outcome
Change in parent-reported severity of children's brain injury symptoms
Time frame: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Assessed with the Health and Behavior Inventory (HBI) on a scale from 0 (Never) to 3 (Often), where higher score indicates more severe symptoms.
Change in parenting self-efficacy assessed with the assessment tool "Parenting Self-Efficacy (TOPSE)"
Time frame: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
The Tool to measure Parenting Self-Efficacy (TOPSE) is rated on a scale from 0 (completely disagree) to 10 (completely agree). Higher total score on the questionnaire indicates higher parenting self-efficacy.
10 secondary outcomes
Change in child-reported severity of brain injury symptoms
Time frame: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in unmet healthcare needs of the family
Time frame: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in children's executive functioning in the home and school environment
Time frame: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in the children's quality of life
Time frame: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in family functioning
Time frame: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in depressive symptoms of the parents
Time frame: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in anxiety symptoms of the parents
Time frame: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Evaluation of the intervention
Time frame: Immediately after the intervention period (T2) (4-5 months after baseline)
Changes in the difficulty score (scale from 0 to 4) of the self- and parental perceived severity of the individually defined target outcome areas
Time frame: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
Change in goal attainment scaling (GAS) in the CICI group
Time frame: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)
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 13 Dec 2023.
- Derived from this study: PubMed 42168942Rohrer-Baumgartner N, Holthe IL, Svendsen EJ, Dahl HM, Borgen IMH, Hauger SL, Brunborg C, Ponsford J, Wade SL, Egeland J, Roe C, Lovstad M. Effects of an individualized and goal-oriented intervention in the chronic phase of pediatric acquired brain injury: the Child in Context Intervention (CICI)-a randomized controlled trial. BMC Pediatr. 2026 May 21;26(1):655. doi: 10.1186/s12887-026-06997-y.
- Derived from this study: PubMed 39283234Holthe IL, Rohrer-Baumgartner NM, Svendsen EJ, Roe C, Borgen IMH, Hauger SL, Ponsford JL, Egeland J, Wade S, Lovstad M. SMART-goal domains and goal attainment in an individualized, goal-oriented intervention for children with acquired brain injury and their families. Neuropsychol Rehabil. 2025 Jul;35(6):1229-1253. doi: 10.1080/09602011.2024.2402095. Epub 2024 Sep 16.
- Derived from this study: PubMed 35193666Rohrer-Baumgartner N, Holthe IL, Svendsen EJ, Roe C, Egeland J, Borgen IMH, Hauger SL, Forslund MV, Brunborg C, Ora HP, Dahl HM, Bragstad LK, Killi EM, Sandhaug M, Kleffelgard I, Strand-Saugnes AP, Dahl-Hilstad I, Ponsford J, Winter L, Wade S, Lovstad M. Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial. Trials. 2022 Feb 22;23(1):169. doi: 10.1186/s13063-022-06048-8.
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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.
Marianne Løvstad, PhD principal investigator
Sunnaas Rehabilitation Hospital and University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family centered in-home rehabilitation in people with Rehabilitation and Brain Injuries, run by Sunnaas Rehabilitation Hospital 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 4 inclusion and 4 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 13 Dec 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 parent-reported severity of children's brain injury symptoms (time frame: Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798859, which also lists 3 linked publications.
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 13 Dec 2023.