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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02316145
Other study ID # 16611
Secondary ID
Status Completed
Phase N/A
First received December 20, 2011
Last updated December 9, 2014
Start date September 2008
Est. completion date December 2010

Study information

Verified date December 2014
Source Vardalinstitutet The Swedish Institute for Health Sciences
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- mental retardation,

- current psychosis,

- current major depression,

- current alcohol and/or substance abuse/dependence,

- severe dyslexia and/or severe psychosocial problems (e.g. criminality)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Habilitation (Internet-based support and coaching)
Support and coaching with therapist (psychologist or educational therapist) by using chat and e-mail

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Vardalinstitutet The Swedish Institute for Health Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary 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". assessed at baseline; immediatelly after intervention and at 6-month follow-up No
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