Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems: Results From a Randomized Clinical Trial

Abstract

Objective Many children with Pervasive Developmental Disorders (PDDs) have serious, functionally-impairing behavioral problems. We tested whether Combined Treatment (COMB) with risperidone and parent training (PT) in behavior management is superior to Medication alone (MED) in improving severe behavioral problems in children with PDDs. Method This 24-week, three-site, randomized, parallel-groups clinical trial enrolled 124 children, aged 4 through 13 years, with PDDs, accompanied by frequent tantrums, self injury, and aggression. Children were randomized 3:2 to COMB (n= 75) or MED (n= 49). Participants received risperidone monotherapy from 0.5 to 3.5 mg/day (with switch to aripiprazole if risperidone was ineffective). Parents in COMB group (N=75; 60.5%) received a mean of 10.9 PT sessions. The primary measure of compliance was the Home Situations Questionnaire (HSQ) score. Results Primary: Intent-to-treat random effects regression showed that COMB was superior to MED on HSQ (p=.006) [effect size at Week 24 (d)= 0.34]. The HSQ score declined from 4.31 (±1.67) to 1.23 (±1.36) for COMB compared with 4.16 (±1.47) to 1.68 (±1.36) for MED. Secondary: Groups did not differ on Clinical Global Impressions–Improvement scores at end-point; compared with MED, COMB showed significant reductions on Aberrant Behavior Checklist Irritability (d=0.48; p= .01), Stereotypic Behavior (d=0.23; p= .04), and Hyperactivity/Noncompliance subscales (d=0.55; p= .04). Final risperidone mean dose for MED was 2.26 mg/day (0.071 mg/kg), compared to 1.98 mg/day for COMB (0.066 mg/kg) (p=.04). Conclusion Medication plus PT resulted in greater reduction of serious maladaptive behavior than medication alone in children with PDDs, with a lower risperidone dose.

Treatment of Psychopathology in People with Intellectual and other Disabilities

“…Finally, there are few studies that have directly and appropriately compared psychotropics with psychosocial interventions. For example, although an RCT by Aman et al 77 demonstrated that combining risperidone with training from parents produced better child outcomes than risperidone alone, the trial did not include a group that only received parent training.…”

Intellectual Disability and Developmental Risk: Promoting Intervention to Improve Child and Family Well‐Being

“…For example, Triple P has been modified for use with parents of children with ID (Stepping Stones Triple P; Plant & Sanders, 2007) and Parent-Child Interaction Therapy has been applied to parents of children with ID (Bagner & Eyberg, 2007). Other similar behavioral parent training programs have been designed and developed specifically for families of children with ID or autism spectrum disorder, such as Signposts for Better Behavior (Hudson et al, 2003) and the RUPP Parent Training program (Aman et al, 2009). Each of these intervention programs has produced meaningful reductions in child problem behavior.…”

Bone mineral density in male adolescents with autism spectrum disorders and disruptive behavior disorder with or without antipsychotic treatment

“…AP reduce maladaptive behaviors, such as irritability, self-injury, stereotypies, and hyperactivity, in children and adolescents with ASD, and reduce irritability and aggressive behavior in children and adolescents with disruptive behavior disorder (DBD) (2).…”