ADHDNCT02300597
Internet-based Support for Young People With ADHD and Autism - a Controlled Study
A study testing Internet based support and coaching in people with ADHD and Autism Spectrum Disorders, run by Göteborg University at 1 site in Sweden.
Trial summary
Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail). Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of… Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- ADHD, Autism Spectrum Disorders
- What is being tested?
- Internet based support and coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2010to Jun 2015
- 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ADHD and/or autism spectrum disorder
- Age 15 to 30
Who cannot join
- No current antisocial behaviour, psychotic symptoms and/or alcohol/substance abuse
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Psychiatry and Neurochemistry, Institute of Neurosceince and Physiology
Gothenburg, SE-413 45
About this study
Official title: Internet-based Support and Coaching for Adolescents and Young Adults With ADHD and Autism Spectrum Disorders - a Controlled Study
Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail). Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status. Parents complete an assessment scale for the next of kin. After treatment the young people are interviewed regarding the quality of the intervention. A comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual and is assessed at the same time points as the intervention group. The individuals are not randomized due to difficulties to recruit if the individuals do not know group assignment in advance.
Read the detailed description
Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are consecutively included in the project and are offered coaching and support during eight weeks over the internet (chat and e-mail) twice a week. Data is collected before and after the intervention as well as six months after end of treatment using self-report questionnaires (Sense of Coherence (SOC), Rosenberg Self Esteem Scale, Manchester Short Assessment of Quality of Life (MANSA), Montgomery Asberg Depression Rating Scale (MADRS), and Hospital Anxiety and Depression Scale (HAD)). A parent or a partner completes an assessment scale for the next of kin. When treatment is completed, the young people are interviewed using a structured interview pertaining to the quality of the intervention. A comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual (TAU) and is assessed at the same time points as the intervention group. The individuals are not randomized to the intervention and comparison groups due to difficulties to recruit if the individuals do not know group assignment in advance. In all, 24 individuals will be offered the intervention and 24 individuals will receive TAU.
- Conditions
- ADHD, Autism Spectrum Disorders
- Being tested
- Internet based support and coaching
- Keywords
- ADHD, Autism Spectrum Disorders, controlled, Internet based, coaching
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet based support and coachingOther
Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail). Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status. Parents complete an assessment scale for the next of kin. After treatment the young people are interviewed regarding the quality of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Internet based support and coaching | Experimental | Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail). Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status. Parents complete an assessment scale for the next of kin. After treatment the young people are interviewed regarding the quality of the intervention. Receives: Other: Internet based support and coaching |
| Treatment as usual (TAU) | No intervention | A comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual and is assessed at the same time points as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoL
Self report questionnaire; Manchester Short Assesment of Quality of Life (MANSA), Priebe et. al. 1999.
Measured: T2: immediately after intervention; T3: 6 months after intervention. Outcome Measure is going to report a change.
Secondary outcomes (4)
Self esteem
Self report questionnaire; Rosenberg Self-Esteem Scale (Rosenberg, 1965, 1989)
Measured: T2: immediately after intervention; T3: 6 months after intervention
Sense of coherence
Self report questionnaire; Sense of Coherence (SOC-29), Antonovsky, 1987.
Measured: T2: immediately after intervention; T3: 6 months after intervention
Anxiety and depressive symptoms
Self report questionnaire; Hospital Anxiety and Depression Scale (HAD), Zigmond \& Snaith, 1983.
Measured: T2: immediately after intervention; T3: 6 months after intervention
Depressive symptoms
Self report questionnaire; Montgomery Asberg Depression Rating Scale (MADRS), Montgomery \& Asberg, 1979.
Measured: T2: immediately after intervention; T3: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startSep 2010
- Primary completionJun 2015
- Study completionJun 2015
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 ADHDStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Södra Älvsborg Hospital, Habilitation Services in Skaraborg, Skövde
- Responsible party
- Principal investigator, Elisabet Wentz, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300597
- Sponsor's protocol ID
- IBSC-2
- Status last verified
- May 2019
- First submitted
- 10 Nov 2014
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Sehlin H, Hedman Ahlstrom B, Andersson G, Wentz E. Experiences of an internet-based support and coaching model for adolescents and young adults with ADHD and autism spectrum disorder -a qualitative study. BMC Psychiatry. 2018 Jan 18;18(1):15. doi: 10.1186/s12888-018-1599-9.
PubMed 29347983
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Support and Coaching for Adolescents and Young Adults With ADHD and Autism Spectrum Disorders - a Controlled Study
- ClinicalTrials.gov ID
- NCT02300597
- Acronym / sponsor ID
- IBSC-2
- Conditions
- ADHD, Autism Spectrum Disorders
- Keywords
- ADHD, Autism Spectrum Disorders, controlled, Internet based, coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Södra Älvsborg Hospital, Habilitation Services in Skaraborg, Skövde
- Study start
- Sep 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Nov 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.
Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail). Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status. Parents complete an assessment scale for the next of kin. After treatment the young people are interviewed regarding the quality of the intervention. A comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual and is assessed at the same time points as the intervention group. The individuals are not randomized due to difficulties to recruit if the individuals do not know group assignment in advance.
Detailed description
Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are consecutively included in the project and are offered coaching and support during eight weeks over the internet (chat and e-mail) twice a week. Data is collected before and after the intervention as well as six months after end of treatment using self-report questionnaires (Sense of Coherence (SOC), Rosenberg Self Esteem Scale, Manchester Short Assessment of Quality of Life (MANSA), Montgomery Asberg Depression Rating Scale (MADRS), and Hospital Anxiety and Depression Scale (HAD)). A parent or a partner completes an assessment scale for the next of kin. When treatment is completed, the young people are interviewed using a structured interview pertaining to the quality of the intervention. A comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual (TAU) and is assessed at the same time points as the intervention group. The individuals are not randomized to the intervention and comparison groups due to difficulties to recruit if the individuals do not know group assignment in advance. In all, 24 individuals will be offered the intervention and 24 individuals will receive TAU.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet based support and coaching | Experimental | Other: Internet based support and coachingYoung people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail). Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status. Parents complete an assessment scale for the next of kin. After treatment the young people are interviewed regarding the quality of the intervention. |
| Treatment as usual (TAU) | No intervention | –A comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual and is assessed at the same time points as the intervention group. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ADHD and/or autism spectrum disorder
- Age 15 to 30
Key exclusion criteria (1 listed)
- No current antisocial behaviour, psychotic symptoms and/or alcohol/substance abuse
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 |
|---|---|---|
| Internet based support and coachingYoung people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail). Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status. Parents complete an assessment scale for the next of kin. After treatment the young people are interviewed regarding the quality of the intervention. | Other | Internet based support and coaching |
Primary outcome
QoL
Time frame: T2: immediately after intervention; T3: 6 months after intervention. Outcome Measure is going to report a change.
Self report questionnaire; Manchester Short Assesment of Quality of Life (MANSA), Priebe et. al. 1999.
4 secondary outcomes
Self esteem
Time frame: T2: immediately after intervention; T3: 6 months after intervention
Sense of coherence
Time frame: T2: immediately after intervention; T3: 6 months after intervention
Anxiety and depressive symptoms
Time frame: T2: immediately after intervention; T3: 6 months after intervention
Depressive symptoms
Time frame: T2: immediately after intervention; T3: 6 months after intervention
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 21 May 2019.
- Derived from this study: PubMed 29347983Sehlin H, Hedman Ahlstrom B, Andersson G, Wentz E. Experiences of an internet-based support and coaching model for adolescents and young adults with ADHD and autism spectrum disorder -a qualitative study. BMC Psychiatry. 2018 Jan 18;18(1):15. doi: 10.1186/s12888-018-1599-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet based support and coaching in people with ADHD and Autism Spectrum Disorders, run by Göteborg University 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 2 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: finished, as of the sponsor's last update on 21 May 2019. 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?
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?
QoL (time frame: T2: immediately after intervention; T3: 6 months after intervention. Outcome Measure is going to report a change.). 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 NCT02300597, 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 21 May 2019.