Measurement of Treatment Effects

Официальное название

Measuring the Effects of Medication and Behavioral Treatments for Challenging Behavior

Обзор

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).

Подробное описание

Our overall objective of this study 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 behavioral treatment, medication, and combination treatment (medication+behavior therapy) will produce reductions in CB, but behavioral treatment and combination treatment will produce a greater reduction in CB when measured using direct observation within the contexts most associated with challenging behavior.

To address this objective, we plan to recruit up to 20 individuals under 13 years of age who are diagnosed with autism and exhibit challenging behavior to participate in this study. Subjects will be recruited from clinics where patients receive consultation on medication for challenging behavior. Subjects will be given the options of initiating/continuing medication, initiating behavior therapy, both medication and behavior therapy, or neither medication nor behavior therapy. The behavioral treatment provided as part of the research study will be functional communication training or FCT. FCT is a scientifically validated behavior therapy that involves teaching the child to use communication (in various forms) instead of challenging behavior to get what they want. It will be delivered at a timing (1 time per week) and dosage (60 minutes per visit) that is common for individuals with challenging behavior. Subjects will participate in a baseline behavioral assessment (baseline), as well as monthly behavioral assessments. Each behavioral assessment will include indirect (rating scales) and direct (antecedent analysis) measures of challenging behavior, as well as measures of social validity (treatment acceptability rating scales). Subjects will be followed for 6 months and comparisons of behavior change across measures will be used to determine treatment effectiveness and concordance between measures.

Вмешательства

• Препарат Psychotropic medication (at discretion of psychiatrist)
  The 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.
• Поведенческое Behavioral therapy
  Functional 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.

Первичные конечные точки

• Aberrant Behavior Checklist, Irritability Subscale [Срок оценки: At enrollment and monthly for 12 months.]
• Behavior Problems Inventory [Срок оценки: At enrollment and monthly for 12 months.]
• Clinical Global Impressions Scale [Срок оценки: At enrollment and every month for 12 months.]
• Home Situations Questionnaire [Срок оценки: At enrollment and monthly for 12 months.]
• Monitoring of Side Effects Scale [Срок оценки: At enrollment and monthly for 12 months.]
• Treatment Acceptability Rating Form - Revised [Срок оценки: Monthly for 12 months.]

Критерии участия

The adult subjects will be the caregiver/guardian of the minor subjects. The only inclusion criterion for the adult subjects is that they must be the caregiver/legal guardian of the minor subject and their home is primarily English speaking.

The minor subjects will be individuals who were referred to Child and Adolescent Psychiatry at University of Iowa Healthcare for management of challenging behavior (e.g., physical aggression, self-injury, destruction, elopement, generalized refusal) and meet the following criteria:

• 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
• Live in a home where English is the primary language spoken.
• The caregiver is considering medication, behavioral therapy, or both to treat the child's challenging behavior.

Subjects would be excluded if:

• Not diagnosed with autism spectrum disorder
• Do not have a moderate or severe/profound intellectual disability
• Do not display challenging behavior
• Live in a home where English is not the primary language spoken
• Caregivers are not considering medication, behavior therapy, or both to treat challenging behavior

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07024303 · 202411526

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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