Cluster-randomized, controlled 12-month trial to evaluate the effect of a parental psychoeducation program on medication persistence in children with attention-deficit/hyperactivity disorder

Figures & data

Table 1 Content of the psychoeducation sessions

Session	Description
1a	Overview of program content and objectives
	ADHD etiology, epidemiology, symptomatology, comorbidities, diagnosis, treatment, prognosis
2	Reasons and sources of bad behavior in children with ADHD and influence on family interactions
	Situational circumstances
	Techniques oriented to improve adequate behavior
	Time optimization
	Reinforcements (verbal, social, physical)
	Positive care
	Token system
3b	Techniques oriented to diminish inadequate behavior
	How to give commands efficiently
	Outdoor time
	How to handle inadequate behavior in public places
	Social skills
	Emotional recognition and expression
	Training in social problem-solving
4	Variables influencing attention problems
	Techniques to improve attention problems
	Interventions for attention problems
	How to support homework
	Barkley’s decalog
5	Recap of previous four sessions

Notes:

a After the first and subsequent three sessions, participants were encouraged to apply what they had learned and to discuss that in the next session.

b After session 3, parents completed a form describing the child’s and parent’s temperaments, and the existence of potential stressing factors in the family that may contribute to worsening of family dynamics.

Abbreviation: ADHD, attention-deficit/hyperactivity disorder.

Table 2 Baseline patient characteristics

Characteristic	Psychoeducation group (n=144)	Control group (n=126)
Age, years (mean [SD])	9.3 (1.9)	8.8 (1.8)
Sex, n (%)
Female	38 (26.4)	37 (29.4)
Male	106 (73.6)	89 (70.6)
Family type, n (%)
Nuclear family	118 (81.9)	100 (79.4)
Adoptive parent	9 (6.3)	10 (7.9)
Divorced parent	16 (11.1)	12 (9.5)
Single parent	1 (0.7)	3 (2.4)
Other	0 (0)	1 (0.8)
Primary caregiver, n (%)
Mother	133 (92.4)	109 (86.5)
Father	11 (7.6)	16 (12.7)
Other	0 (0)	1 (0.8)
Disorder, n (%)
Affective	2 (1.4)	0 (0)
Anxiety	4 (2.8)	8 (6.3)
Oppositional defiant	19 (13.2)	12 (9.5)
Conduct	7 (4.9)	5 (4.0)
Learning	29 (20.1)	22 (17.5)
Time since diagnosis, days (mean [SD])	6.7 (8.4)	7.2 (8.6)
Diagnosis subtype, n (%)
Inattentive	47 (32.6)	21 (16.7)
Hyperactive	8 (5.6)	2 (1.6)
Combined	89 (61.8)	103 (81.7)
ADHD-RS-IV Parent:Inv score, mean (SD)	36.2 (9.0)	39.5 (9.0)
CGI-ADHD-S score, mean (SD)	5.0 (0.9)	5.0 (1.0)
WFIRS-P score, mean (SD)
Total	0.8 (0.4)	0.8 (0.4)
Home domain	1.0 (0.6)	1.0 (0.6)
School domain	1.0 (0.5)	1.0 (0.5)
Self-concept domain	0.9 (0.8)	0.8 (0.8)
Social domain	0.8 (0.6)	0.7 (0.6)
Activities of daily living domain	0.9 (0.5)	0.9 (0.4)
Risk-taking domain	0.4 (0.4)	0.4 (0.4)

Abbreviations: ADHD-RS-IV Parent:Inv, Attention-Deficit/Hyperactivity Disorder Rating Scale IV-Parent version; CGI-ADHD-S, Clinical Global Impression ADHD-Severity scale; SD, standard deviation; WFIRS-P, Weiss Functional Impairment Rating Scale-Parent version.

Figure 1 Patient disposition.

Abbreviation: FAS, full analysis set.

Table 3 Discontinuations during the study

Parameter	Psychoeducation (n=144)	Control (n=126)
Completed (n [%])	116 (80.6)	92 (73.0)
Reason for discontinuation (n [%])
Cluster dissolution	0 (0.0)	2 (1.6)
Adverse event	2 (1.4)	7 (5.6)
Death	0 (0.0)	0 (0.0)
Protocol violation	0 (0.0)	3 (2.4)
Subject decision	1 (0.7)	0 (0.0)
Physician decision	0 (0.0)	3 (2.4)
Sponsor decision	5 (3.5)	0 (0.0)
Parent/caregiver decision	10 (6.9)	12 (9.5)
Start of structured psychotherapy aimed at ADHD	1 (0.7)	0 (0.0)
Pharmacologic withdrawal	1 (0.7)	1 (0.8)
Lost to follow-up	8 (5.6)	3 (2.4)
Unknown	0 (0.0)	3 (2.4)

Abbreviation: ADHD, attention-deficit/hyperactivity disorder.

Figure 2 Pharmacologic treatment usage during the study.

Notes: ^aJanssen Pharmaceuticals, Inc., Titusville, NJ, USA; ^bLaboratorios Rubió, Barcelona, Spain; ^cMedice Arzneimittel Pütter GmbH & Co. KG, Iserlohn, Germany; ^dLilly USA, LLC, Indianapolis, IN, USA.

Figure 3 Estimated time to treatment discontinuation (Kaplan–Meier).

Abbreviation: TRT, treatment.

Table 4 Cox proportional hazards model for time until treatment discontinuation ≤12 months; analysis of covariates

	Parameter estimate	P-value	HR	95% CI
				Lower	Upper
Treatment (intervention or control)	−0.3	0.343	0.715	0.358	1.430
Type of diagnosisa	−0.0	0.911	0.956	0.430	2.123
Comorbidityb
Oppositional defiant disorders	−0.0	0.931	0.956	0.349	2.624
Anxiety disorders	−0.2	0.807	0.832	0.191	3.628
Learning disorders	1.2	<0.001	3.189	1.654	6.146
Conduct disorders	0.4	0.561	1.484	0.392	5.613
Affective disorders	1.6	0.057	5.158	0.952	27.931

Notes:

a Hyperactive or combined versus inattentive.

b Presence versus absence.

Abbreviations: CI, confidence interval; HR, hazard ratio.

Figure 4 Change in ADHD-RS-IV Parent:Inv total score (least squares mean estimate) for the psychoeducation and control groups.

Abbreviations: ADHD-RS-IV Parent:Inv, Attention-Deficit/Hyperactivity Disorder Rating Scale IV-Parent version; CI, confidence interval.

Figure 5 Change in CGI-ADHD-S total score (least squares mean estimate) for the psychoeducation and control groups.

Abbreviations: CGI-ADHD-S, Clinical Global Impression-Attention-Deficit/Hyperactivity Disorder-Severity scale; CI, confidence interval.

Figure 6 Drug usage patterns during the study.

Table 5 Protocol-emergent adverse events reported by ≥5% of patients

Parameter, n (%)	Psychoeducation (n=144)	Control (n=126)	Overall (n=270)
At least one protocol-emergent adverse event	54 (37.5)	60 (47.6)	114 (42.2)
Decreased appetite	21 (14.6)	22 (17.5)	43 (15.9)
Headache	20 (13.9)	10 (7.9)	30 (11.1)
Abdominal pain	13 (9.0)	12 (9.5)	25 (9.3)
Pyrexia	8 (5.6)	9 (7.1)	17 (6.3)
Insomnia	7 (4.9)	9 (7.1)	16 (5.9)
Nasopharyngitis	3 (2.1)	11 (8.7)	14 (5.2)