Autism Spectrum DisordersIMPACNCT06381856
Improving Participation of Autistic Children and Adolescents in the Habilitation Process
An observational study of Autism Spectrum Disorders, run by Region Örebro County at 1 site in Sweden.
Trial summary
This project aims to explore the impact of a survey-based and a meeting-based needs assessment models on 7 to 17 year old autistic children's participation in the needs assessment process at the initial reception when enrolled at a Child and Youth Habilitation Centre. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Autism Spectrum Disorders
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 13 Jan 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents receiving the survey based needs assessment and their parents/guardians (The survey-based needs assessment cohort). Children and adolescents receiving the personal meeting needs assessment and their parents/guardians (The personal-meeting needs assessment cohort).
Who may be able to join
- autism spectrum disorder
Who cannot join
- intellectual disability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
University Health Care Research Center
Örebro, Örebro County, 70182
About this study
This project aims to explore the impact of a survey-based and a meeting-based needs assessment models on 7 to 17 year old autistic children's participation in the needs assessment process at the initial reception when enrolled at a Child and Youth Habilitation Centre.
Read the detailed description
The increasing number of children diagnosed with autism spectrum disorder (ASD) presents significant challenges for healthcare providers. Research emphasizes the importance of involving children in their healthcare decisions. However, due to the complex nature of ASD, characterized by differences in communication and social interaction, healthcare professionals struggle to adapt their services for these children.
To address this issue, the present study compares two assessment methods for children with ASD: one based on surveys and another based on meetings with healthcare professionals. In addition, supplementary information from the children's parents or guardians and healthcare providers will be gathered .
Data collection methods will include questionnaires, interviews, and analysis of individual habilitation plans. The goal is to recruit 120 children aged 7-17 diagnosed with ASD but without intellectual disabilities, with half undergoing the survey-based assessment and the other half undergoing the meeting-based assessment.
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism spectrum disorder, Patient participation, Needs assessment, Child, Adolescent, Parent
- Medical subject headings
- Autism Spectrum Disorder, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| survey based needs assessment | cohort receiving survey based needs assessment | |
| Personal meeting based assessment | cohort receiving personal meeting based needs assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The child's involvement
Consist of seven to nine questions relating to the child's involvement and engagement during a needs assessment meeting. The form is available in three versions. One for each child/youth, parent/guardian and staff. Each version comes in two variants. A variant for a regular meeting and a variant for the closing meeting. The questions are rated on 4-point Likert scales from "Not at all" to "Very much".
Measured: After each of four needs assessment meetings that take place over a 2-month period, with the first meeting scheduled to take place one month after inclusion.
Secondary outcomes (4)
The Mental Health Continuum - Short Form
Consists of 14 questions which is assessed on a 6-point Likert scale and measures mental health in three domains (emotional, psychological and social well-being). The form appears in three versions. One where the child/youth assesses his/hers own health, one where the parent/guardian assesses his/hers own health and one where the parent/guardian assesses the child's/youth's health (i.e., proxy assessment).
Measured: At inclusion in the study and after completed needs assessment approximately 3 months after inclusion
The "Your child's strengths, abilities and special needs"-questionnaire.
Consists of four or five questions from the "Family outcome survey" and adapted to the study's target group. The questions are answered by the parent/guardian and relate to their understanding of the child's strengths, abilities and special needs. The questions are answered on a 5-point scale Likert scales from "Nothing/Not at all" to "All/Always". The form is available in two variants. One for measurement before completed needs assessment (four questions) and one for measurement after completed needs assessment (five questions).
Measured: At inclusion in the study and after completed needs assessment approximately 3 months after inclusion
The collaboration with the neuropsychiatric team questionnaire
Consists of five questions relating to the family's contact with the neuropsychiatric team team at the Child and Youth Habilitation. The questions are answered with five answer options.
Measured: After completed needs assessment approximately 3 months after inclusion
Cantril ladder
Measures quality of life and is assessed on a picture of a ladder numbered from zero to ten.
Measured: At inclusion in the study and after completed needs assessment approximately 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start13 Jan 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars-Olov Lundqvist, Professor, Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381856
- Sponsor's protocol ID
- EPM_2024-00227-01
- Acronym
- IMPAC
- Status last verified
- Aug 2025
- First submitted
- 15 Apr 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lundqvist LO, Sjodin L, Karvonen E, Arnell S. Evaluating the impact of needs assessment models on autistic children's participation in the habilitation process: protocol for a prospective observational study. BMJ Open. 2024 Nov 1;14(10):e089135. doi: 10.1136/bmjopen-2024-089135.
PubMed 39486811
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Participation of Autistic Children and Adolescents in the Habilitation Process
- ClinicalTrials.gov ID
- NCT06381856
- Acronym / sponsor ID
- IMPAC / EPM_2024-00227-01
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism spectrum disorder, Patient participation, Needs assessment, Child, Adolescent, Parent
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Apr 2024 (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.
This project aims to explore the impact of a survey-based and a meeting-based needs assessment models on 7 to 17 year old autistic children's participation in the needs assessment process at the initial reception when enrolled at a Child and Youth Habilitation Centre.
Detailed description
The increasing number of children diagnosed with autism spectrum disorder (ASD) presents significant challenges for healthcare providers. Research emphasizes the importance of involving children in their healthcare decisions. However, due to the complex nature of ASD, characterized by differences in communication and social interaction, healthcare professionals struggle to adapt their services for these children.
To address this issue, the present study compares two assessment methods for children with ASD: one based on surveys and another based on meetings with healthcare professionals. In addition, supplementary information from the children's parents or guardians and healthcare providers will be gathered .
Data collection methods will include questionnaires, interviews, and analysis of individual habilitation plans. The goal is to recruit 120 children aged 7-17 diagnosed with ASD but without intellectual disabilities, with half undergoing the survey-based assessment and the other half undergoing the meeting-based assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| survey based needs assessment | – | –cohort receiving survey based needs assessment |
| Personal meeting based assessment | – | –cohort receiving personal meeting based needs assessment |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents receiving the survey based needs assessment and their parents/guardians (The survey-based needs assessment cohort). Children and adolescents receiving the personal meeting needs assessment and their parents/guardians (The personal-meeting needs assessment cohort).
Key inclusion criteria (1 listed)
- autism spectrum disorder
Key exclusion criteria (1 listed)
- intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The child's involvement
Time frame: After each of four needs assessment meetings that take place over a 2-month period, with the first meeting scheduled to take place one month after inclusion.
Consist of seven to nine questions relating to the child's involvement and engagement during a needs assessment meeting. The form is available in three versions. One for each child/youth, parent/guardian and staff. Each version comes in two variants. A variant for a regular meeting and a variant for the closing meeting. The questions are rated on 4-point Likert scales from "Not at all" to "Very much".
4 secondary outcomes
The Mental Health Continuum - Short Form
Time frame: At inclusion in the study and after completed needs assessment approximately 3 months after inclusion
The "Your child's strengths, abilities and special needs"-questionnaire.
Time frame: At inclusion in the study and after completed needs assessment approximately 3 months after inclusion
The collaboration with the neuropsychiatric team questionnaire
Time frame: After completed needs assessment approximately 3 months after inclusion
Cantril ladder
Time frame: At inclusion in the study and after completed needs assessment approximately 3 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 39486811Lundqvist LO, Sjodin L, Karvonen E, Arnell S. Evaluating the impact of needs assessment models on autistic children's participation in the habilitation process: protocol for a prospective observational study. BMJ Open. 2024 Nov 1;14(10):e089135. doi: 10.1136/bmjopen-2024-089135.
- 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.
Lars-Olov Lundqvist, Professor principal investigator
Region Örebro County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorders, run by Region Örebro County at 1 site in Sweden.
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: enrolling by invitation, as of the sponsor's last update on 11 Aug 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
The child's involvement (time frame: After each of four needs assessment meetings that take place over a 2-month period, with the first meeting scheduled to take place one month after inclusion.). 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 NCT06381856, which also lists 1 linked publication.
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 11 Aug 2025.