Measurement of Treatment Effects
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age2-12
SponsorMatthew J O'Brien, PhD, BCBA-D
About this trial
The overall objective is to evaluate and compare the efficacy of two common treatments for CB in children and adolescents with autism using multiple outcome measures. Our central hypothesis is that both behavioral treatment and medication will produce reductions in CB, but behavioral treatments, including behavior treatment + medication, will produce a greater reduction in CB when measured using direct observation within the contexts most associated with challenging behavior. We have four aims: Aim 1: Evaluate the concordance between indirect and direct measures of challenging behavior. We hypothesize that behavior change (% change) will be discordant between indirect and direct measurement data, regardless of treatment type, with direct measurement resulting in significantly greater change at each measurement timepoint. Aim 2: Compare the efficacy of psychotropic medication, behavior therapy, and combination therapy (medication+behavior therapy) on CB using indirect measures (ABC-I, BPI, CGI, MOSES) and direct observation (antecedent analysis). We hypothesize that all treatment modalities will reduce CB on both outcome measures at each standard timepoint, but behavioral therapy and combination therapy will produce a significantly greater reduction on direct observation of CB in the contexts most associated with challenging behavior. Aim 3: Compare the social validity of psychotropic medication, behavior therapy, and combination therapy using the Treatment Acceptability Rating Form-Revised (Reimers et al., 1992). Aim 4: Compare the social validity of measurement methods (indirect vs. direct).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between the ages of 2 years, 0 months and 12 years, 0 months
Diagnosed with autism spectrum disorder
Diagnosed with intellectual disability at the moderate, severe, or profound range (called "profound autism").
Display challenging behavior, including one or more of the following: physical aggression, self-injury, destruction, elopement, generalized refusal
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Psychotropic medication (at discretion of psychiatrist)
DrugThe timing and dose of medication will be determined by the prescribing provider. Most medications are delivered daily and some medications may be delivered more than once per day. Providers are expected to adhere to professional guidelines for prescribing.
Behavioral therapy
BehavioralFunctional communication training (FCT) will be delivered for 1 hour every week in-vivo or via telehealth. This timing and dosage has been shown effective in previous research. However, caregivers will be encouraged to practice the treatment procedures as often as possible on their own. Treatment will be delivered by a therapist and/or caregiver for those receiving in-vivo therapy and caregivers will deliver treatment with coaching from a therapist when using telehealth.
Treatment groups
20 Participants
are divided into 4 treatment groupsGroup A: Psychotropic MedicationExperimental treatment 1 intervention
Group B: Behavior TherapyExperimental treatment 1 intervention
Group C: Combined Treatment (Medication+Behavior Therapy)Experimental treatment 2 interventions
Group D: No TreatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Aberrant Behavior Checklist, Irritability Subscale
The ABC-I is a subscale of the 58-item ABC rating scale, which more broadly measures irritability, social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech (Aman et al., 1985). Items are rated on a 4-point. Likert scale from 0 to 3, with higher ratings corresponding to greater concern. Recent research has provided normative data for children with ASD, illustrating the validity of the five-factor structure and appropriate convergent and divergent validity (Kaat et al., 2014) as well as excellent internal consistency for the subscale of interest (Irritability = 0.92; Norris et al., 2019). The ABC-I consists of 15 items that measure child irritable mood and is commonly used to measure the effects of pharmacotherapy or behavioral therapy on disruptive behavior in children with autism (Bearss et al., 2015; Goel et al., 2018).
Time frame
At enrollment and monthly for 12 months.2
Behavior Problems Inventory
The BPI is a 52-item scale used to assess problem behavior in individuals with neurodevelopmental disabilities (Rojahn et al., 2001). Specific behaviors (e.g., hits others, bites self) are scored on a 5-point frequency scale (0 = never, 4 = hourly) and a 4-point severity scale (0 = no problem, 3 = severe problem). The BPI measures three types of behavior: self-injurious behaviors, stereotyped behavior, and aggressive or destructive behavior. The BPI has been determined to demonstrate reasonable validity and reliability (e.g., Rojahn et al., 2001).
Time frame
At enrollment and monthly for 12 months.3
Clinical Global Impressions Scale
The CGI is a comprehensive, clinician-determined summary measure that integrates all available information, including the patient's history, psychosocial context, symptoms, behavior, and the impact of symptoms on functional ability. The CGI consists of two single-item measures: (a) the severity of psychopathology, rated on a 1 to 7 scale, and (b) the change from the initiation of treatment, also rated on a seven-point scale. This measure is delivered following a clinical evaluation. The CGI has shown strong correlations with established research drug efficacy scales. The standard CGI is widely used in FDA-regulated trials.
Time frame
At enrollment and every month for 12 months.4
Home Situations Questionnaire
The HSQ-PDD is a 25-item scale used to assess behavioral compliance in everyday settings. It is typically completed by parents of individuals with ASD (Chowdhury et al., 2010). The HSQ-PDD is a modified version of the original HSQ (Barkley \& Edelbrock 1987) and includes additional items identified as relevant to children with ASD (e.g., when asked to move from one activity to another; when there is an unexpected change in routine). When completing the measure, the rater must first identify whether an item is a challenge for the child and then rate the severity of the problem on a 9-point Likert scale (1 = mild, 9 = severe). The HSQ-PDD consists of two factors (Socially Inflexible, 14 items; Demand-Specific, 6 items). Internal consistency for the scale as a whole is excellent (Chowdhury et al., 2010).
Time frame
At enrollment and monthly for 12 months.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Matthew J O'Brien, PhD, BCBA-D
Lead sponsor
University of Iowa
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: