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Internet-based Support for Young People With ADHD and Autism - a Controlled Study

Primary Purpose

ADHD, Autism Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet based support and coaching
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, Autism Spectrum Disorders, controlled, Internet based, coaching

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ADHD and/or autism spectrum disorder
  • Age 15 to 30

Exclusion Criteria:

  • No current antisocial behaviour, psychotic symptoms and/or alcohol/substance abuse

Sites / Locations

  • Department of Psychiatry and Neurochemistry, Institute of Neurosceince and Physiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet based support and coaching

Treatment as usual (TAU)

Arm Description

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.

Outcomes

Primary Outcome Measures

QoL
Self report questionnaire; Manchester Short Assesment of Quality of Life (MANSA), Priebe et. al. 1999.

Secondary Outcome Measures

Self esteem
Self report questionnaire; Rosenberg Self-Esteem Scale (Rosenberg, 1965, 1989)
Sense of coherence
Self report questionnaire; Sense of Coherence (SOC-29), Antonovsky, 1987.
Anxiety and depressive symptoms
Self report questionnaire; Hospital Anxiety and Depression Scale (HAD), Zigmond & Snaith, 1983.
Depressive symptoms
Self report questionnaire; Montgomery Asberg Depression Rating Scale (MADRS), Montgomery & Asberg, 1979.

Full Information

First Posted
November 10, 2014
Last Updated
May 20, 2019
Sponsor
Göteborg University
Collaborators
Södra Älvsborg Hospital, Habilitation Services in Skaraborg, Skövde
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1. Study Identification

Unique Protocol Identification Number
NCT02300597
Brief Title
Internet-based Support for Young People With ADHD and Autism - a Controlled Study
Official Title
Internet-based Support and Coaching for Adolescents and Young Adults With ADHD and Autism Spectrum Disorders - a Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Göteborg University
Collaborators
Södra Älvsborg Hospital, Habilitation Services in Skaraborg, Skövde

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Autism Spectrum Disorders
Keywords
ADHD, Autism Spectrum Disorders, controlled, Internet based, coaching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet based support and coaching
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Internet based support and coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
QoL
Description
Self report questionnaire; Manchester Short Assesment of Quality of Life (MANSA), Priebe et. al. 1999.
Time Frame
T2: immediately after intervention; T3: 6 months after intervention. Outcome Measure is going to report a change.
Secondary Outcome Measure Information:
Title
Self esteem
Description
Self report questionnaire; Rosenberg Self-Esteem Scale (Rosenberg, 1965, 1989)
Time Frame
T2: immediately after intervention; T3: 6 months after intervention
Title
Sense of coherence
Description
Self report questionnaire; Sense of Coherence (SOC-29), Antonovsky, 1987.
Time Frame
T2: immediately after intervention; T3: 6 months after intervention
Title
Anxiety and depressive symptoms
Description
Self report questionnaire; Hospital Anxiety and Depression Scale (HAD), Zigmond & Snaith, 1983.
Time Frame
T2: immediately after intervention; T3: 6 months after intervention
Title
Depressive symptoms
Description
Self report questionnaire; Montgomery Asberg Depression Rating Scale (MADRS), Montgomery & Asberg, 1979.
Time Frame
T2: immediately after intervention; T3: 6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ADHD and/or autism spectrum disorder Age 15 to 30 Exclusion Criteria: No current antisocial behaviour, psychotic symptoms and/or alcohol/substance abuse
Facility Information:
Facility Name
Department of Psychiatry and Neurochemistry, Institute of Neurosceince and Physiology
City
Gothenburg
ZIP/Postal Code
SE-413 45
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
29347983
Citation
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.
Results Reference
derived

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Internet-based Support for Young People With ADHD and Autism - a Controlled Study

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