This is a clinical trial of a novel intervention, Behavioral Therapy for Irritability and Aggression (BTIA), for adolescents on the autism spectrum. The main goals of BTIA are to help adolescents develop emotion regulation skills to handle frustration and to strengthen skills for navigating the challenging and diverse experiences associated with the transition to adulthood. The study will test whether BTIA can be helpful to adolescents on the autism spectrum and to their families.
This is a randomized controlled study of BTIA versus a supportive therapy control condition in 126 adolescents (ages 12 to 18 years) with a diagnosis of autism spectrum disorder and significant levels of disruptive behaviors such as aggression, anger outbursts, and oppositional behavior. BTIA consists of 15 ninety-minute weekly sessions that will be conducted with the teens and their parents by therapists using a structured, detailed manual. The effects of BTIA on the reduction of behavioral problems will be rated by an experienced clinician who does not know which treatment each participant is receiving (a "blinded" evaluator). Study participants will receive a thorough diagnostic assessment of autism spectrum disorder and other forms of psychopathology that may co-occur with ASD. In addition to testing the effects of BTIA on disruptive behavior, the changes in adaptive functioning, or children's ability to function competently in their everyday environment, will be examined before and after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
The child-focused components of BTIA are organized in modules dedicated to emotion regulation, problem solving and practice of planned steps to prevent or resolve conflicts. Each session contains a set of six to seven goals, and each goal contains a menu of techniques and activities that can be used to attain this goal. In order to administer the treatment in a flexible yet reliable manner, the therapist works collaboratively with the child and his or her parents to select activities that are perceived as relevant for attaining the session's goal. The parent-focused components of BTIA include include education about the effects of antecedents and consequences on disruptive behavior, developing strategies for reducing or altering antecedent events that may lead to disruptive reactions and helping parents to use reinforcement of competent and calm responses in potentially frustrating situations.
Each PST session will start with a review of events of the past week and include queries of topics such as school, interests, hobbies, and family with an overarching goal of enhancing subjective well-being. A major objective is to enables the participant to discuss his or her concerns with a therapist toward a goal of enhancing overall psychological wellbeing. Education about autism diagnosis and services is also provided to families as part of PST.
Yale Child Study Center
New Haven, Connecticut, United States
Modified Overt Aggression Scale (MOAS)
Modified Overt Aggression Scale is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior. Scores can range from 0 (minimum) to 300 (maximum) with higher scores reflecting worse outcome.
Time frame: baseline (week 0)
Modified Overt Aggression Scale (MOAS)
Modified Overt Aggression Scale is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior. Scores can range from 0 (minimum) to 300 (maximum) with higher scores reflecting worse outcome.
Time frame: midpoint (week 8)
Modified Overt Aggression Scale (MOAS)
Modified Overt Aggression Scale is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior. Scores can range from 0 (minimum) to 300 (maximum) with higher scores reflecting worse outcome.
Time frame: endpoint (week 16)
Modified Overt Aggression Scale (MOAS)
Modified Overt Aggression Scale is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior. Scores can range from 0 (minimum) to 300 (maximum) with higher scores reflecting worse outcome.
Time frame: six-month follow up (week 42)
The Clinical Global Impression - Improvement Score (CGI-I)
The Clinical Global Impression - Improvement Score assigned by an independent evaluator (IE) who will be blind to treatment assignment is the categorical primary outcome measure of aggressive behavior. The CGI-I reflects the IE's assessment of overall change from baseline rated on a scale from 1 to 7 where 1 is very much improved, 2 is much improved, 3 is minimally improved, 4 is no change, 5 is minimally worse, 6 is much worth, and 7 is very much worse. Higher scores reflect worse outcome. By convention, ratings of very much improved (1) or much improved (2) define positive response; all other scores are classified as a negative response.
Time frame: baseline (week 0)
The Clinical Global Impression - Improvement Score (CGI-I)
The Clinical Global Impression - Improvement Score assigned by an independent evaluator (IE) who will be blind to treatment assignment is the categorical primary outcome measure of aggressive behavior. The CGI-I reflects the IE's assessment of overall change from baseline rated on a scale from 1 to 7 where 1 is very much improved, 2 is much improved, 3 is minimally improved, 4 is no change, 5 is minimally worse, 6 is much worth, and 7 is very much worse. Higher scores reflect worse outcome. By convention, ratings of very much improved (1) or much improved (2) define positive response; all other scores are classified as a negative response.
Time frame: midpoint (week 8)
The Clinical Global Impression - Improvement Score (CGI-I)
The Clinical Global Impression - Improvement Score assigned by an independent evaluator (IE) who will be blind to treatment assignment is the categorical primary outcome measure of aggressive behavior. The CGI-I reflects the IE's assessment of overall change from baseline rated on a scale from 1 to 7 where 1 is very much improved, 2 is much improved, 3 is minimally improved, 4 is no change, 5 is minimally worse, 6 is much worth, and 7 is very much worse. Higher scores reflect worse outcome. By convention, ratings of very much improved (1) or much improved (2) define positive response; all other scores are classified as a negative response.
Time frame: endpoint (week 16)
The Clinical Global Impression - Improvement Score (CGI-I)
The Clinical Global Impression - Improvement Score assigned by an independent evaluator (IE) who will be blind to treatment assignment is the categorical primary outcome measure of aggressive behavior. The CGI-I reflects the IE's assessment of overall change from baseline rated on a scale from 1 to 7 where 1 is very much improved, 2 is much improved, 3 is minimally improved, 4 is no change, 5 is minimally worse, 6 is much worth, and 7 is very much worse. Higher scores reflect worse outcome. By convention, ratings of very much improved (1) or much improved (2) define positive response; all other scores are classified as a negative response.
Time frame: six-month follow up (week 42)
Irritability subscale - Aberrant Behavioral Checklist
The 15-item Irritability subscale includes questions about aggression, tantrums, agitation, and unstable mood that are rated on a 4-point scale with the following anchor points: 0 = not at all a problem; 1 = the behavior is a problem but slight in degree; 2 = the problem is moderately serious; 3 = the problem is severe in degree. The total Irritability subscale score ranges from 0 to 45, with higher scores indicating greater severity.
Time frame: baseline (week 0)
Irritability subscale - Aberrant Behavioral Checklist
The 15-item Irritability subscale includes questions about aggression, tantrums, agitation, and unstable mood that are rated on a 4-point scale with the following anchor points: 0 = not at all a problem; 1 = the behavior is a problem but slight in degree; 2 = the problem is moderately serious; 3 = the problem is severe in degree. The total Irritability subscale score ranges from 0 to 45, with higher scores indicating greater severity.
Time frame: midpoint (week 8)
Irritability subscale - Aberrant Behavioral Checklist
The 15-item Irritability subscale includes questions about aggression, tantrums, agitation, and unstable mood that are rated on a 4-point scale with the following anchor points: 0 = not at all a problem; 1 = the behavior is a problem but slight in degree; 2 = the problem is moderately serious; 3 = the problem is severe in degree. The total Irritability subscale score ranges from 0 to 45, with higher scores indicating greater severity.
Time frame: endpoint (week 16)
Irritability subscale - Aberrant Behavioral Checklist
The 15-item Irritability subscale includes questions about aggression, tantrums, agitation, and unstable mood that are rated on a 4-point scale with the following anchor points: 0 = not at all a problem; 1 = the behavior is a problem but slight in degree; 2 = the problem is moderately serious; 3 = the problem is severe in degree. The total Irritability subscale score ranges from 0 to 45, with higher scores indicating greater severity.
Time frame: six-month follow up (week 42)
Vineland Adaptive Behavior Scales - Communication Domain Score
Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is a measure of competence in communication, daily living skills, and socialization which is administered in a semi-structured parent interview format. Items assess the individual's behavior in these domains and are rated according to the frequency with which behaviors are performed without help or prompting (i.e., "Never," "Sometimes" or "Usually"). The raw scores are converted to standard scores (mean = 100, SD = 15; range 40 to 160), and higher scores indicate better adaptive functioning.
Time frame: baseline (week 0)
Vineland Adaptive Behavior Scales - Communication Domain Score
Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is a measure of competence in communication, daily living skills, and socialization which is administered in a semi-structured parent interview format. Items assess the individual's behavior in these domains and are rated according to the frequency with which behaviors are performed without help or prompting (i.e., "Never," "Sometimes" or "Usually"). The raw scores are converted to standard scores (mean = 100, SD = 15; range 40 to 160), and higher scores indicate better adaptive functioning.
Time frame: endpoint (week 16)
Vineland Adaptive Behavior Scales - Communication Domain Score
Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is a measure of competence in communication, daily living skills, and socialization which is administered in a semi-structured parent interview format. Items assess the individual's behavior in these domains and are rated according to the frequency with which behaviors are performed without help or prompting (i.e., "Never," "Sometimes" or "Usually"). The raw scores are converted to standard scores (mean = 100, SD = 15; range 40 to 160), and higher scores indicate better adaptive functioning.
Time frame: six-month follow up (week 42)
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