Attention Deficit Hyperactivity DisorderNCT02316145
Internet-based Coaching for Young Adults With Neuropsychiatric Disorders
A study testing Habilitation (Internet-based support and coaching) in people with Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder, run by Vardalinstitutet The Swedish Institute for Health Sciences.
Trial summary
Purpose: To develop a model for internet-based support and coaching to young adults with neuropsychiatric disorders (NPD). To improve the individual's psychosocial functioning and his/her understanding of how he/she is functioning. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Tourette's Disorder
- What is being tested?
- Habilitation (Internet-based support and coaching)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Dec 2010
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The individuals had to fulfill a diagnosis of ADHD, Tourette's disorder and/or an ASD (autistic disorder, Asperger's disorder or pervasive developmental disorder not otherwise specified (PDD NOS), according to the DSM-IV (APA, 1994).
- The inclusion age was between 15 and 26 years.
Who cannot join
- mental retardation,
- current psychosis,
- current major depression,
- current alcohol and/or substance abuse/dependence,
- severe dyslexia and/or severe psychosocial problems (e.g. criminality)
About this study
Official title: Internet-based Support and Coaching for Young Adults With Neuropsychiatric Disorders - A Pilot Study
Purpose: To develop a model for internet-based support and coaching to young adults with neuropsychiatric disorders (NPD). To improve the individual's psychosocial functioning and his/her understanding of how he/she is functioning.
NPD comprise problems with social interaction, attention, impulse control and hyperactivity. The most common NPD diagnoses are ADHD (attention deficit hyperactivity disorder), autism spectrum condition (ASC) and Tourette's disorder (TD). In this study the investigators use Internet-based treatment for young adults with NPD.
Method: Support/coaching by using communication over the Internet (chat and e-mail) with individuals with NPD. Twice every week during 8 weeks, young adults with NPD are offered support and coaching over the Internet by psychologist/educational therapist with great experience from NPD. The individuals are assessed before and after treatment pertaining to quality of life, sense of coherence, self-esteem, depressive and anxiety symptoms, and parents' evaluation of the young adult's situation.
Read the detailed description
Aims: To develop an internet-based support and coaching model for young people with autism spectrum disorder (ASD) and/or attention-deficit/hyperactivity disorder (ADHD), and to validate the model. Method: A user centred design was applied to develop a model for internet-based support and coaching, where individuals received eight-week support via internet (chat). The model was validated by ten individuals, 15 to 26 years of age, with ASD and/or ADHD. Self-report questionnaires (Sense of Coherence (SOC), the Rosenberg Self Esteem Scale, the Manchester Short Assessment of Quality of Life (MANSA), Montgomery Åsberg Depression Rating Scale (MADRS), and the Hospital Anxiety and Depression Scale (HAD)) were distributed before and after intervention. A structured interview regarding the quality of the model, the Patient perspective of Care and Rehabilitation process (POCR), was used after the intervention. Results: The validation showed significant improvement of SOC, self-esteem and subjective Quality of Life at follow-up and the majority perceived high fulfilment/importance on the POCR. Conclusions: The model can be an important complement to other interventions for young people with ASD and/or ADHD.
- Being tested
- Habilitation (Internet-based support and coaching)
- Keywords
- ADHD, Autism spectrum condition, Tourette's disorder, Internet-based, chat, coach
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habilitation (Internet-based support and coaching)Behavioural
Support and coaching with therapist (psychologist or educational therapist) by using chat and e-mail
| Study group | Role | What they receive |
|---|---|---|
| 'Habilitation (Internet-based support) | Other | Before the individual started with the internet-based support and coaching (IBSC), a meeting with the coach was compulsory to discuss what specific issues they were going to work with during the period of IBSC. The IBSC was offered at fixed times twice a week during an eight-week period. Two meetings between the individual and the coach were included. Between chat sessions the individuals and the coaches could get in touch using the programme's e-mail. The content of the support and coaching was individualised based on each individual's requirement. Once a fortnight a meeting was held with the head of the project and coaches. Issues regarding ongoing support and coaching were addressed. Receives: Behavioral: Habilitation (Internet-based support and coaching) |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life (QoL)
The Manchester Short Assessment of Quality of Life (MANSA) is a 16-item scale that consists of four objective QoL questions and 12 questions pertaining to "life as a whole, job (or studies), financial situation, friendships, leisure activities, accommodation, personal safety, people that the person lives with, family and health".
Measured: assessed at baseline; immediatelly after intervention and at 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startSep 2008
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vardalinstitutet The Swedish Institute for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabet Wentz, MD, PhD, Study chair, Child Neuropsychiatry Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316145
- Sponsor's protocol ID
- 16611
- Status last verified
- Dec 2014
- First submitted
- 20 Dec 2011
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Support and Coaching for Young Adults With Neuropsychiatric Disorders - A Pilot Study
- ClinicalTrials.gov ID
- NCT02316145
- Acronym / sponsor ID
- 16611
- Keywords
- ADHD, Autism spectrum condition, Tourette's disorder, Internet-based, chat, coach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vardalinstitutet The Swedish Institute for Health SciencesUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Dec 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.
Purpose: To develop a model for internet-based support and coaching to young adults with neuropsychiatric disorders (NPD). To improve the individual's psychosocial functioning and his/her understanding of how he/she is functioning.
NPD comprise problems with social interaction, attention, impulse control and hyperactivity. The most common NPD diagnoses are ADHD (attention deficit hyperactivity disorder), autism spectrum condition (ASC) and Tourette's disorder (TD). In this study the investigators use Internet-based treatment for young adults with NPD.
Method: Support/coaching by using communication over the Internet (chat and e-mail) with individuals with NPD. Twice every week during 8 weeks, young adults with NPD are offered support and coaching over the Internet by psychologist/educational therapist with great experience from NPD. The individuals are assessed before and after treatment pertaining to quality of life, sense of coherence, self-esteem, depressive and anxiety symptoms, and parents' evaluation of the young adult's situation.
Detailed description
Aims: To develop an internet-based support and coaching model for young people with autism spectrum disorder (ASD) and/or attention-deficit/hyperactivity disorder (ADHD), and to validate the model. Method: A user centred design was applied to develop a model for internet-based support and coaching, where individuals received eight-week support via internet (chat). The model was validated by ten individuals, 15 to 26 years of age, with ASD and/or ADHD. Self-report questionnaires (Sense of Coherence (SOC), the Rosenberg Self Esteem Scale, the Manchester Short Assessment of Quality of Life (MANSA), Montgomery Åsberg Depression Rating Scale (MADRS), and the Hospital Anxiety and Depression Scale (HAD)) were distributed before and after intervention. A structured interview regarding the quality of the model, the Patient perspective of Care and Rehabilitation process (POCR), was used after the intervention. Results: The validation showed significant improvement of SOC, self-esteem and subjective Quality of Life at follow-up and the majority perceived high fulfilment/importance on the POCR. Conclusions: The model can be an important complement to other interventions for young people with ASD and/or ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 'Habilitation (Internet-based support) | Other | Behavioral: Habilitation (Internet-based support and coaching)Before the individual started with the internet-based support and coaching (IBSC), a meeting with the coach was compulsory to discuss what specific issues they were going to work with during the period of IBSC. The IBSC was offered at fixed times twice a week during an eight-week period. Two meetings between the individual and the coach were included. Between chat sessions the individuals and the coaches could get in touch using the programme's e-mail. The content of the support and coaching was individualised based on each individual's requirement. Once a fortnight a meeting was held with the head of the project and coaches. Issues regarding ongoing support and coaching were addressed. |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The individuals had to fulfill a diagnosis of ADHD, Tourette's disorder and/or an ASD (autistic disorder, Asperger's disorder or pervasive developmental disorder not otherwise specified (PDD NOS), according to the DSM-IV (APA, 1994).
- The inclusion age was between 15 and 26 years.
Key exclusion criteria (5 listed)
- mental retardation,
- current psychosis,
- current major depression,
- current alcohol and/or substance abuse/dependence,
- severe dyslexia and/or severe psychosocial problems (e.g. criminality)
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 |
|---|---|---|
| Habilitation (Internet-based support and coaching)Support and coaching with therapist (psychologist or educational therapist) by using chat and e-mail | Behavioural | 'Habilitation (Internet-based support) |
Primary outcome
quality of life (QoL)
Time frame: assessed at baseline; immediatelly after intervention and at 6-month follow-up
The Manchester Short Assessment of Quality of Life (MANSA) is a 16-item scale that consists of four objective QoL questions and 12 questions pertaining to "life as a whole, job (or studies), financial situation, friendships, leisure activities, accommodation, personal safety, people that the person lives with, family and health".
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 12 Dec 2014.
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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.
Elisabet Wentz, MD, PhD study chair
Child Neuropsychiatry Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Habilitation (Internet-based support and coaching) in people with Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder, run by Vardalinstitutet The Swedish Institute for Health Sciences.
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 5 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 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
quality of life (QoL) (time frame: assessed at baseline; immediatelly after intervention and at 6-month follow-up). 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 12 Dec 2014.