Psychoeducation in families of children with attention deficit hyperactivity disorder (ADHD) in Spain
| ISRCTN | ISRCTN32884424 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32884424 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/01/2010
- Registration date
- 24/02/2010
- Last edited
- 24/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Maite Ferrin
Scientific
Scientific
Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO)
Dr Azpitarte 4, Edificio Licinio de la Fuente, 4ª planta
Granada
18014
Spain
| Phone | +34 958 02 02 45 |
|---|---|
| maiteferrin@yahoo.es |
Study information
| Study design | Single centre randomised controlled double-blind parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Psychoeducation in families of children with attention deficit hyperactivity disorder (ADHD) in Spain: evaluation of the efficacy in a randomised controlled trial |
| Study objectives | 1. Psychoeducation intervention in families of attention deficit hyperactivity disorder (ADHD) children/adolescents will lead to a significant reduction of ADHD symptoms in these children in comparison with a control group 2. Psychoeducation intervention in families of ADHD children/adolescents will lead to improvement of treatment adherence rates in these children in comparison with a control group 3. Psychoeducation intervention in families of ADHD children/adolescents will lead to improvement of quality of life in these families in comparison with a control group |
| Ethics approval(s) | Local medical ethics committee (Complejo Hospitalario de Jaen, Spain) approved in September 2007 |
| Health condition(s) or problem(s) studied | Attention deficit disorder (ADD)/attention deficit hyperactivity disorder (ADHD) |
| Intervention | Psychoeducation intervention (experimental group): Families of ADHD children/adolescents attending psychoeducation sessions. Psychoeducation provided by Child and Adolescent Psychiatrist and consisting of 12 weekly sessions, 90 minutes length, groups of 8 - 10 families. Sessions organisation: 1. 10 - 20 minutes: "warm-up" period, informal conversation, doubts from the previous session 2. 30 - 35 minutes: lecture on the topic 3. 10 minutes: brief pause 4. 30 - 40 minutes: topic discussion Participants encouraged to ask and make comments. Psychoeducation program for ADHD: Session 1: Presentations and group functioning rules. What is ADHD? Session 2: Core symptoms. Diagnostic procedures Session 3: Etiological, maintaining and perpetuating factors Session 4: Comorbidities in ADHD Session 5: Prognosis and outcome: ADHD in the adolescent and the adult Session 6: Executive function Session 7: Pharmacological treatments: stimulants and non-stimulants Session 8: Diets and other treatments Session 9: Cognitive behavioural treatment and other management approaches Session 10: Dealing with everyday-life problems at home I Session 11: Dealing with everyday-life problems at home II Session 12: Dealing with everyday-life problems at school Session 13: Summarising, final questions and doubts. Closing down session. Support group (active control group): Families of ADHD children/adolescents. Parents attending 12 weekly sessions, 90 minutes length, groups of 8 - 10 families, non-structured support groups provided by the same Child and Adolescent Psychiatrist. Control group only differs on the educational content provided. |
| Intervention type | Other |
| Primary outcome measure | ADHD-symptoms by Conners Scale, measured at baseline, 12 weeks, 6 months, 9 months, and 15 months |
| Secondary outcome measures | 1. Attitudes Towards Treatment Questionnaire (QATT) 2. Adherence levels measured by direct questioning to families and pill counting (integrated into a composite) 3. Psychiatric conditions: Strengths and Difficulties Questionnaire (SDQ) 4. Children's Global Assessment Scale (C-GAS) 5. Clinical Global Impression (CGI) 6. Quality of life by PedsQL™ Core Version 4 and Cognitive Scale 7. Satisfaction with psychoeducation program by the Consumer Satisfaction Questionnaire 8. Parents Stress Index (PSI), 3th Edition Assessments on all measures pre-treatment and post-treatment. Follow-up assessment on all measures after 3 months, 6 months and 12 months. |
| Overall study start date | 01/09/2009 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 70 (35 intervention group, 35 control group) |
| Key inclusion criteria | 1. Diagnosis of attention deficit disorder (ADD)/ADHD in child (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition [DSM-IV]), with most of their co-morbidity represented (except for the exclusion criteria), and any treatment prescribed 2. Age of child between 3 and 19 years, either sex 3. Informed consent of the parents and the children available 4. Parents' age greater than or equal to 18 years 5. Responsibility and legal capacity in parents 6. Participant on clinical ADHD symptoms stabilisation for at least 1 month before entering the study (with or without medical treatment) |
| Key exclusion criteria | 1. Severe Autistic Spectrum Disorders (*) 2. Severe learning disabilities (*) 3. Earlier or current participation in other intervention trials that might interfere with the current study (*) due to added problems to ADHD, thus requiring a different sort of intervention |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO)
Granada
18014
Spain
18014
Spain
Sponsor information
Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO) (Spain)
Research organisation
Research organisation
Dr Azpitarte 4, edificio Licinio de la Fuente, 4ª planta
Granada
18014
Spain
| Phone | +34 958 02 02 45 |
|---|---|
| pilar.martinez.exts@juntadeandalucia.es | |
| Website | http://www.fibao.es/ |
Funders
Funder type
Charity
The Alicia Koplowitz Foundation (Fundacion Alicia Koplowitz) (Spain)
No information available
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref: ETS 07/90902)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
