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Single blind RCT, randomization by minimization
N: 69 families
-Psychoeducation intervention (experimental group): Families of ADHD children/adolescents attending psychoeducation sessions.
6 weekly sessions (2 sessions per week),
120 min,
8 - 10 families.
-Treatment integrity supervised by an external person
-T0, T1 (end of treatment 6 weeks), T2 (6 months FU)
-Control group: TAU
-Intention to treat
-Supervision by CTU
-PRIMARY OUTCOME: ADHD Index (CPRS-R:S, 2008).
-SECONDARY OUTCOMES:
ADHD subscales (CPRS-R:S); ADHD subscales (CTRS-R:S); SDQ subscales (Goodman 1997); QoL (EuroQol-5D), Family Impact (PedsQL,Varni 1998), Parents' stress PSI -3rd Ed (Abidin 1997); Global functioning C-GAS (Bird 1987), Clinical impression CGI-S (Guy 1976)
Variables measured at: T (baseline), T (after the program) and T (12/6 months follow-up)
Discussion 1.
-Other alternatives to pharmacological treatments are an option
- Spain: comparison with an support control group, blind outcomes
-potential benefits of psychoeducation for reducing ADHD total and cognitive symptoms while improving pro-social aspects
-benefits vanish in the long term: booster sessions?
-effects for reducing stress, impact or improving QoL: sample size, active control group, increasing awareness?
-London: replication of results using TAU, shorter interventions and non-blind outcomes:
-reduction of ADHD total and cognitive symptoms in the follow-up
-longer interventions might be required; consistent with psycho-education theories
Discussion 2:
Strengths:
-moderate effect sizes (0.096, 0.102, and 0.047 eta squares for Index, Inn/cog/ prosocial respectively)
-efficacy using blind outcomes (PROXI-measures), which do not generalize to other settings (school)(P-BLIND) (Sonuga-Barke et al. 2013)
-mechanism of psychoeducation unknown: better recognition of symptoms, improving positive parenting practices
-for the real benefits, efficacy takes a time to be obtained and need booster sessions
Limitations:
-not direct comparison with medication
-limited sample size, not co-varied for age, comorbidities, subtypes
AIMS:
To evaluate the efficacy of a well-structured psychoeducation programme in families with ADHD children/adolescents:
1. Reduction of ADHD symptoms (ADHD Index as primary outcome)
2. Improvement of other psychological and clinical outcomes (secondary outcomes: ADHD symptoms, psychopathology, global functioning, QoL, parent stress, family impact)
.... in comparison with a control group.
What is a proper
psychoeducation intervention ?
1.carried out by a sensitive and sympathetic therapist (+co-therapists),
2. group sittings
3.lasting approx 1-1´5 hour
4. once or twice a week
5. 4-16 sessions
(Bäuml 2006)
Method - 1
Qualitative study
Methods-2
Quantitative study
Focus groups conducted following each 6-week programme; all programme participants invited
Three small groups to date (n=8 in total); two further groups expected
First group conducted in June 2010
Participants all mothers
Facilitator an independent qualitative researcher
Semi-structured topic guide
Method - 2
Qualitative study
Adapted from Colom F, Vieta E, Scott J (2006)
Psychoeducation Manual for Bipolar Disorder. Cambridge Uni Press.
Discussion audio recorded with participants’ informed consent
Recordings transcribed ‘intelligent verbatim’
Transcripts coded with the assistance of NVivo 8™ software
Coding and thematic analysis guided by the broad aims of the focus group study
-PRIMARY OUTCOME: ADHD symptoms (Conners Parents scale 2008).
-SECONDARY OUTCOMES: SDQ (Goodman 1997); QUALITY OF LIFE (PedsQL by Varni 1998), PARENTAL STRESS INDEX PSI -3RD ED (Abidin 1997); Attitudes Towards Treatment by QATT (Ferrin 2010); Adherence levels by direct questioning and BARS (Byerly et al. 2008) ; C-GAS (Bird 1987); CGI (Guy 1976)
Variables measured at: T₀ (baseline), T₁ (6 weeks, after the programme) and T₂ (6 month follow-up)
Analysis using SPSS ™ version 15.0; comparison using Student’s t test and MANOVA for repeated measures
Methods -1
Quantitative study
Blind controlled trial RCT using randomization by minimization
Sample: 70 families of ADHD children/adolescents:
Psychoeducation intervention (experimental group): Families of ADHD children/adolescents attending psychoeducation sessions. Psychoeducation consisting of 6 weekly sessions, 120 min, in groups of 8 - 10 families.
Control group: Routine medical care.
INFORMATION
Session 1. The psychoeducation program; presentation of the program, structure and rules
Session 2. What is ADHD? Symptoms and diagnosis
Session 3. Etiological factors; what causes ADHD? Maintaining and perpetuating factors
Session 4. Comorbities in ADHD
Session 5. Prognosis and outcome; ADHD in the adolescent and the adult
Session 6. Executive dysfunction
Session 7. Pharmacological treatments: stimulants and non-stimulants
Session 8. Non pharmacological treatments: diets, cognitive and psychological treatments
Session 9. Dealing with everyday-life problems: Managing the child at home I
Session 10. Dealing with everyday-life problems: Managing the child at home II
Session 11. Dealing with everyday-life problems: Managing the child at school
Session 12. Summarizing, final questions and doubts. Closing down session
MANAGEMENT
Qualitative study; Aims:
To elicit parents' experiences and views of the organisation, content and delivery, and the usefulness of the psycho education programme for families of children with ADHD
2. To use these findings to inform the future development of the programme
THE SUNSHINE STUDY
PSYCHOEDUCATION FOR FAMILIES WITH ADHD CHILDREN/ADOLESCENTS IN
SOUTH EAST LONDON (2010-2012)
Registered: ISRCTN 26270684
PSYCHOEDUCATION FOR FAMILIES WITH
ADHD CHILDREN/ADOLESCENTS
IN JAEN, SPAIN (2008-2010)
Registered: ISRCTN 32884424
(Sonuga-Barke et al. 2013)
M-Proxi vs. P-Blind
INCLUSION CRITERIA:
-ADHD [DSM-IV], any co-morbidity, any treatment
-5 - 19 years of age, either sex
-Informed consent of the parents and the children
-Parents' age ≥ 18 years ; legal capacity in parents
-Clinical ADHD symptoms stabilization
≥ 1 month before entering the study
EXCLUSION CRITERIA:
-Severe ASD or LD
-Earlier or current participation in other intervention
trials that might interfere with the current study
"Double blind"* RCT, simple randomization N: 81 families
-Psychoeducation intervention (experimental group): Families of ADHD children/adolescents attending psychoeducation sessions.
12 weekly sessions,
120 min,
8 - 10 families.
-Control group: support groups, same format, reunited and encouraged to comment on their thoughts and share their experiences
-Treatment integrity supervised by an external person
-T0, T1 (end of treatment week 12), T2 (12 months FU)
-Intention to treat
* Parents unaware of treatment condition received!
Psychoeducation in UK
Psychoeducat. N=21
Drop out=0 (0%)
Psychoeducation in UK
Control N=18
Drop out=2 (11%)
Sessions’ organization:
Participants: ADHD children or adolescents’ parents
12 weekly sessions, 1h30min. length each session:
-10-20 min: “warm-up” period, informal conversation,
doubts from the previous session
-30-35 min: lecture on the topic
-10 min: brief pause
-30-40 min: topic discussion
Participants encouraged to ask and make comments.
Handout and homework at the end of each session.
“For me, there were parts of ADHD I hadn’t looked into before. I didn’t know the ODD [Oppositional Defiance Disorder] part of it. When I read that, it was just so typically [my son] and I’d just put that down to him acting up extra… I just thought he was being naughty, being a pest and just trying to push me as far as I can go. It’s not, it’s all part of the condition and now I understand it more and I can sort of deal with it more and think right, okay, he might need the extra help here and there. So this is part of it and not just him acting up and other things that have happened, they’re not just reactions, it is part of it.” (Alison; Group 3)
#Double-Blind RCT. Simple randomization. Families blind to study
#Psychoeducation (N=43 families ,12 weekly sessions)
Vs. Active-Control (N=37 families, 12 weekly non-structured support groups).
Psychoeducation in Spain
Psychoeducation in Spain
GROUPS
“Usually I would say, ‘I want you to do this’ or, ‘I want you to play that’. Now it’s his choice but we do it as a family… like the Wii, mine has this coordination problem and so has the other child, so we actually go on the Wii, like the hula-hoop one [laughter], especially with the coordination. Before we would laugh, but we don’t do it now, we say to him, ‘Focus. Concentrate. Look at the screen’. Things like that. But I’ve learnt not to control an activity, [but] to be the follower. They call me that at home - Sean the Sheep - anyway [laughter]. They need the activity and I find it works and the home is much calmer… I think being on the course has taught me that sometimes you need to take a step back and be the follower. It’s worked.” (Carol; Group 3)
ES= 0,60
p= 0,02
Psychoeducation
Control
T0 T1 (after intervention) T2 (12 months)
(MTA study 1999)
Parents with schools
Preliminary qualitative findings
“Also, with the schools, let’s say there is a meeting or they call you about your child… When you get there, you know how to talk to them and how to work with them now with this information we’ve got.” (Zoe; Group 1)
“Mine’s had a lot of problems in school and still has problems in school. Being on the programme has opened my eyes so I know how to deal with him at home and how he needs to be dealt with at school. Also for the future because he’s ten and now he’s going into Year 6, so the element of preparing for secondary school and how to do it and the best way to go about it.” (Carol; Group 3)
Focus on parents
Preliminary qualitative findings
“… when you go on the courses, you have an understanding, you don’t feel like you’re alone. There are some parents that you meet that you might end up being friends with after - or just all the information that’s available. I don’t feel like I’m alone or I need extra support.” (Hazel; Group 3)
“… it was an eye opener, I’m glad I came and met all the different parents, made new friends, and I’ve learnt a lot in the last six weeks.” (Katie; Group 1)
“ even though you’re learning but you’re also giving back, you are helping other families with your own experience” (Louise; Group 2)
Multidisciplinary approaches for ADHD are needed
Psychoeducation program in Spain:
Efficacy for reducing ADHD symptoms and psychopathology
Moderate to large effect size (0.6-0.89)-independently of medical treatment received!
Effect of intervention tend to diminish over time→ booster sessions?
In UK: Quantitative and qualitative evaluation
We aim to replicate these findings
IS PSYCHOEDUCATION IN ADHD REALLY EVIDENCE-BASED?
-Benefits of psycho-social treatments yet to be established
(Sonuga-Barke et al. 2013)
-Evidence for psychoeducation in ADHD patients/families specifically is scarce:
-only 7 RCT according to a systematic review;
-important methodological flaws
-educational strategies not strictly applied
-more RCTs are needed in this field
(Montoya, Colom & Ferrin 2011)
Results. Baseline characteristics of the samples
Maite Ferrin MD, MSc, PhD
Huntercombe Hospital Maidenhead
University of Southampton
Results. Secondary outcomes: family stress, CGI, quality of life (Ferrin et al. submitted)
Results. Primary outcome: reduction of ADHD symptoms (Ferrin et al., submitted)
Results. Secondary outcomes: psychopathology (SDQ), ADHD (P-Blind, CTRS) (Ferrin et al. submitted)
Results. Preliminary findings: reduction of ADHD symptoms (Ferrin et al., in prep)
(*)