Condition category
Mental and Behavioural Disorders
Date applied
30/01/2010
Date assigned
24/02/2010
Last edited
24/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maite Ferrin

ORCID ID

Contact details

Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO)
Dr Azpitarte 4
Edificio Licinio de la Fuente
4ª planta
Granada
18014
Spain
+34 958 02 02 45
maiteferrin@yahoo.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Psychoeducation in families of children with attention deficit hyperactivity disorder (ADHD) in Spain: evaluation of the efficacy in a randomised controlled trial

Acronym

Study hypothesis

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

Local medical ethics committee (Complejo Hospitalario de Jaen, Spain) approved in September 2007

Study design

Single centre randomised controlled double-blind parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2009

Overall trial end date

01/09/2010

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

70 (35 intervention group, 35 control group)

Participant 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

Recruitment start date

01/09/2009

Recruitment end date

01/09/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO)
Granada
18014
Spain

Sponsor information

Organisation

Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO) (Spain)

Sponsor details

Dr Azpitarte 4
edificio Licinio de la Fuente
4ª planta
Granada
18014
Spain
+34 958 02 02 45
pilar.martinez.exts@juntadeandalucia.es

Sponsor type

Research organisation

Website

http://www.fibao.es/

Funders

Funder type

Charity

Funder name

The Alicia Koplowitz Foundation (Fundacion Alicia Koplowitz) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref: ETS 07/90902)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes