Combined Effects of Early Behavioral Intervention and Propranolol on ASD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02428205|
Recruitment Status : Recruiting
First Posted : April 28, 2015
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism||Drug: Propranolol Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Combined Effects of Early Behavioral Intervention and Propranolol on ASD|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Propranolol arm
Propranolol will be administered in the form of a liquid dose via oral syringe by the participants' parent/caregiver an hour before each EIBI session. To minimize risk, the bodyweight adjusted minimum dose of propranolol used safely for test anxiety in healthy adults (10mg) will be used: participants weighing > 30 kg will be given 4 mg, participants weighing 22.5 - 30 kg will be given 3 mg, participants weighing 15 - 22.5 kg will be given 2 mg. Participants weighing < 15 kg will be excluded for safety reasons.
Participant will receive Propranolol prior to each EIBI session
Other Name: Inderal
Placebo Comparator: Placebo arm
Placebo will be administered in the form of a liquid dose via oral syringe by the participants' parent/caregiver an hour before each EIBI session.The same bodyweight adjusted doses specified in the propranolol arm will be used for this arm.
Participant will receive placebo prior to each EIBI session
- Change in General Social Outcome Measure (GSOM) [ Time Frame: Week 1, Week 6, Week 12 ]The GSOM is a brief evaluation tool that measures a participant's level of social functioning and how it changes with intervention. There GSOM includes 4 different tasks: conversational reciprocity, ability to recognize facial expressions, social problem solving, affect demonstration, and emotional perspective taking. The experimenter administers each component of the GSOM to the participant and then scores their responses according to a pre-determined scoring rubric. Each component is scored on a 1-5 or 0 - 2 scale, with higher total scores indicating better social functioning. A video camera will be used to record the participant's behavior during GSOM administration for the purposes of having two independent raters score the tasks after the study session is complete. The video camera will be turned off for the remainder of the study session. A camera will also be used during the affect demonstration task of the GSOM.
- Change in Social Responsiveness Scale (SRS) [ Time Frame: Week 1, Week 6, Week 12 ]This 65-item, parent-report measure asks questions about a participants' social awareness, social information processing, capacity for reciprocal social responses, social anxiety or avoidance, and characteristic autistic preoccupations or traits.
- Change in Preschool Anxiety Scale (PAS) [ Time Frame: Week 1, Week 6, Week 12 ]To assess anxiety, the PAS will be completed by the parents/caregivers of participants. This self-report measure yields a total score in addition to six subscales (separation anxiety, social phobia, obsessive compulsive, panic/agoraphobia, physical injury fears, and generalized anxiety).
- Change in Clinical Global Impression of Change (CGIC) scale [ Time Frame: Baseline, Week 6, Week 12 ]To assess overall changes in the participant's ASD-related clinical symptoms, the CGIC will be administered. The CGIC consists of a 7-point subjective scale assessing change from baseline, initially assessed via the the Clinical Global Impression of Severity (CGIS) scale (CGIS). On the CGIC scale, scores of 1, 2, and 3 represent marked, moderate, and mild improvement, respectively. A score of 4 represents no change. Scores of 5, 6, and 7 represent mild, moderate, and marked worsening, respectively. CGIC scores from both the parent/caregiver and a blinded clinician will be utilized.
- Change in Clinical Global Impression of Severity (CGIS) scale [ Time Frame: Week 1, Week 6, Week 12 ]To assess overall severity of a participant's ASD-related clinical symptoms, the CGIS will be administered. The CGIS consists of a 7-point subjective scale assessing symptom severity. On this scale, scores of 1, 2, and 3 represent normal, some presence of symptoms, and mild behavior, respectively. A score of 4 represents moderate behavior. Scores of 5, 6, and 7 represent marked, severe, and among the most severe behavior, respectively. CGIS scores from both the parent/caregiver and a blinded clinician will be utilized.
- Change in Aberrant Behavior Checklist (ABC) [ Time Frame: Week 1, Week 6, Week 12 ]To assess overall behavioral disturbances, a parent/caregiver of the participants will complete ABC. This 58-item questionnaire is a well validated, reliable, and widely used assessment tool for interventions for a range of cognitive disorders.
- Change in Vineland Adaptive Behavior Scales-II (VABS) [ Time Frame: Week 1, Week 6, Week 12 ]To assess overall adaptive functioning, the VABS will be administered in the form of a structured interview with the parent/caregiver. The VABS is a well validated assessment used for the full range of our subjects' ages and yields standard scores in Communication, Daily Living Skills, Socialization, and Motor Skills. VABS scores for Communication, Daily Living Skills, and Socialization will be monitored in this study.
- Change in Autism Impact Measure (AIM) [ Time Frame: Week 1, Week 6, Week 12 ]The AIM will be administered to assess the frequency and impact of a participant's ASD-related symptoms. A parent/caregiver is asked a series of 41 questions regarding the frequency and the impact, or interference resulting from, a series of autism-associated behaviors. Overall impact and frequency scores, as well as subscale scores, will be obtained from this measure.
- Change in Preschool Language Scale (PLS): [ Time Frame: Week 1, Week 6, Week 12 ]To evaluate language, we will administer the PLS, which has been developed for use in younger children (birth through age 7), and is appropriate for children of all ability levels, including nonverbal children. This play-based, interactive assessment is designed to assess receptive and expressive language skills and their change over time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428205
|Contact: David Q Beversdorf, MDfirstname.lastname@example.org|
|Contact: Neetu Nair, BTechemail@example.com|
|United States, Missouri|
|Thompson Center for Autism & Neurodevelopmental Disorders||Recruiting|
|Columbia, Missouri, United States, 65211|
|Contact: David Q Beversdorf, MD 573-882-6081 firstname.lastname@example.org|
|Contact: Neetu Nair, BTech 573-882-0131 email@example.com|
|Principal Investigator: David Q Beversdorf, MD|
|Principal Investigator:||David Q Beversdorf, MD||University of Missouri-Columbia|