William Pelham - US grants

The proposed studies will explore new aspects of the relationship between parental drinking and deviant child behavior. We shall further investigate the role of family history in (a) increased ad lib alcohol consumption (stress-induced drinking, SID) in parents in response to their interacting with a deviant (externalizing disordered) child, and (b) the nature of deterioration in parent management strategies due to alcohol. The study will also examine the relationship between family risk for alcohol problems, parental SID, and certain cognitive and behavioral characteristics of their children. Specifically, the following questions will be pursued: (1) Do parents of deviant children with positive family history for alcoholism show greater SID occasioned by interacting with a deviant child relative to Low Family Risk parents? (2) Does alcohol produce a dampening of the stress response produced by interacting with a deviant child (stress-response dampening, SRD)? (3) What specific aspects of the management skills and perceptions of parents interacting with their own problem children are affected by alcohol? and (4) Do children with attention deficit hyperactivity disorder (ADHD) have behavioral and cognitive characteristics that vary as a function of their own comorbid diagnoses, their family risk of alcoholism and other parental characteristics, including SID and SRD effects of alcohol? These questions will be addressed through several studies. In the first, mothers and fathers (half each with positive and negative family histories) of ADHD children will interact on two occasions with child confederates who enact either nominal child or deviant child roles. Following an initial interaction with a confederate, subjects will have the opportunity to drink prior to a second interaction with the same child. In another experiment, parents from the first study with high and low levels of SID will interact with their own deviant children on two occasions--once following administration of a fixed dose of alcohol and once following a nonalcoholic beverage. A third experiment will examine individual differences on a number of dimensions in the children whose parents participate in experiments 1 and 2, with the goal of determining how ADHD children with and without positive family histories for alcoholism compare on measures that are thought to be predictive of alcohol abuse. The children will perform a variety of tasks that were specifically selected to measure risk markers and mechanisms for alcoholism and substance abuse, and they will be compared to other children at various levels of risk. Altogether the studies are designed to elucidate the relationship between deviant childhood behavior, family risk, and alcohol problems.

Despite the strong empirical evidence supporting the efficacy of CNS stimulants in the short-term treatment of Attention Deficit Hyperactivity Disorder (ADHD), controversies concerning its use continue. Prominent among these is whether cognitive-motivational factors that include children's control beliefs (i.e., attributions they make for the causes of their behavior and performance) both influence response to medication and are affected by medication. In particular, influential researchers have argued for some time that medication induces dysfunctional control beliefs in children with ADHD (i.e., they attribute their behavior and abilities to the medication), but there has been little systematic research on the topic. Many studies from the developmental literature on children's achievement have shown that attributions are important mediators of children's performance. If medicated ADHD boys tend to attribute their successes to medication and to blame themselves for their failures in life, then despite the salutary short-term effects of medication, they would be unlikely to demonstrate effortful, persistent behavior when faced with difficult social and academic situations. The purpose of the proposed series of studies is to examine the relationship between pharmacotherapy with methylphenidate and ADHD children's control beliefs, behavior, task persistence and self-evaluations. These studies are unique in three ways. First, with the exception of the preliminary studies discussed in this proposal, they constitute the first comprehensive examination of this important issue. Second, they involve the first application of a balanced placebo design (a design that completely crosses actual medication vs. placebo with expectation for medication vs. placebo) to pharmacotherapy for ADHD, thus affording the first investigation of ADHD children's expectancies on their response to medication. Third, they are the first studies to employ the current leading model of cognitive motivation from the developmental literature to pharmacotherapy of ADHD. Using this unique approach, 120 ADHD boys ranging in age from 8 to 13.6 will serve as subjects in three studies conducted over a four-year period. Study 1 will employ two laboratory tasks to study individual differences in the pharmacological vs expectancy effects of medication on ADHD children's task persistence under success vs. failure conditions in both academic and social domains of functioning. Study 2 will examine the pharmacological versus expectancy effects of medication on social and academic behavior, performance self-evaluations, and control beliefs of ADHD boys in the context of a summer treatment program. Study 3 will examine the same issues considered in Study 2 within the same children's regular school settings, thereby affording information regarding generalizability of the findings from the laboratory and treatment program studies. Given the importance of individual differences in this area of research, the design and analyses of all three studies will consider the effects of age, codiagnosis, and attributional style.

Recent conceptualizations of attention deficit hyperactivity disorder (ADHD) have emphasized its chronicity and refractoriness. Despite numerous studies that have examined the short-term efficacies of psychostimulant medication, psychosocial treatments such as behavior modification, and combined pharmacological and behavioral treatments, it is clear (a) that all of these treatments lack sufficiency in the short-term and (b) that no intervention has documented long-term effectiveness. As a result, there is no clear answer to the question, "What constitutes the best treatment for ADHD?" There are widely disparate answers to this question within the professional community, with some arguing strongly for the efficacy and sufficiency of pharmacological interventions, while others argue just as strongly for the primacy of psychosocial treatments, and still others believe that combined interventions will prove most efficacious. The purpose of the proposed study is to address some of the unanswered questions regarding the best treatment for ADHD by evaluating the separate and combined efficacies of several different treatments for ADHD children. Thus, eighty ADHD children will be recruited to participate in a three-year study in which they will be assigned to one of three psychosocial treatment groups: (1) Maximum intensity treatment consisting of parent training, intervention within the children's home school settings, and intervention for peer relationships and academic deficits provided through intensive summer treatment (STP) and Saturday treatment (SaTP) programs; (2) intensive outpatient treatment consisting of the same parent training and intervention within the children's home school settings provided to the maximum intensity group; and (3) a contact control group. After four months of treatment, all children will participate in a double-blind, placebo-controlled, within-subject medication assessment conducted in their school and home settings. Based on this assessment, children who are positive responders to medication within each psychosocial treatment group will be assigned to one of three medication groups, with medication to continue concurrently with continued psychosocial treatment: (a) best dose CNS stimulant t.i.d. 7 days per week; (b) best dose CNS stimulant b.i.d. on school days only (with placebo necessary to match pill regimen of the first group); and (c) placebo t.i.d. 7 days per week. Concurrent psychosocial and pharmacological treatment will continue for two years. At the end of this period, medication will be withdrawn from half of the children. Periodic assessments will evaluate the child's functioning in the family, classroom, and peer domains. The major questions addressed involve the relative efficacies of the separate and combined treatments and whether treatment efficacy interacts with domain of functioning and individual difference variables that include age, gender, severity of impairment, comorbid child diagnoses, self-perceptions of competence, attributional style, parental psychopathology, family SES, and parental marital status.

Numerous studies of the effects of CNS stimulants on the behavior and cognition of boys with attention deficit-hyperactivity disorder (ADHD) have documented the short-term efficacy of these drugs on a broad range of dependent measures that include social behavior and cognitive performance, both measured in a variety of ways and settings. However, the overwhelming percentage of subjects in these studies have been ll years of age or younger. Given that it is clear that the majority of ADHD children do not remit at age 11, an important question for some time has been whether stimulant medication continues to be an efficacious treatment with ADHD children beyond the age of 11. Unfortunately, empirical data that address this question are virtually nonexistent. Therefore, the purpose of this investigation is to extend to a young adolescent sample the research that has been conducted with young ADHD children. A dose-response analysis will be conducted of the effects of methylphenidate on the cognitive and social behaviors of sixty 12 to 15 year old ADHD adolescents. In each of three consecutive summers, twenty 12 to 15 year old ADHD adolescents participating in a summer day treatment program will undergo a double-blind, placebo-controlled trial in which each adolescent will receive, for six days each with order randomized over days, no medication, placebo, .15, .3 and .6 mg/kg methylphenidate (MPH) b.i.d. Classroom dependent measures will include the following: accuracy and productivity on in-class assignments, attention to lecture, quantity and quality of notes taken, test performance, rule violations, and teacher ratings. Other dependent measures will be gathered in a variety of settings during the day treatment program, including recreational periods and group discussions, and will include frequency counts of positive and negative verbalizations directed towards peers and staff members, frequency counts of conduct problems and prosocial behaviors, rule violations, noncompliance to staff requests and commands, staff and parent ratings, laboratory measures of cognitive performance, and parent-adolescent interactions. Data analyses will address the following: (1) What is the shape of the function that relates dose to response for methylphenidate in this sample? (2) Does that shape vary across and/or within domains of response (e.g., cognitive versus social behavior; complex versus simple cognitive tasks; prosocial versus antisocial behavior)? (3) Are the obtained dose-response functions related to subject characteristics that include comorbid diagnosis of conduct disorder? Following their medication trials in the summer program, adolescents will be assigned to their best dose of medication given on either a b.i.d.-weekdays or t.i.d.-7 days schedule and followed for the subsequent school year to determine whether the effects of an acute trial of methylphenidate maintain with continued administration.

This Competing Continuation Application requests funding for years 06 to 10 of the NIMH collaborative Multimodal Treatment Study of Children with Attention-Deficit Hyperactivity Disorder (MTA Study). In a parallel-group design, 576 rigorously diagnosed children with ADHD (96 'at each of 6 sites), age 7-9, are randomly assigned to four treatment conditions: (1) Medication-only Treatment; (2) Psychosocial-only Treatment; (3) Combined (medication & psychosocial) Treatment; or (4) Assessment-and-Referral-only condition. All but the latter are treated intensively for 14 months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original MTA design thus provides short-term (10 months post- treatment) follow-up at 24 months, but insufficient funds and time prevented longer-term follow-up. This Continuation request, in concert with the companion Competing Supplement for years 04 and 05, would begin the longer-term follow-up of differential treatment effects by following all subjects at least through their 5th year (4 yr post- treatment). Continuation Aim I is to conduct confirmatory tests of the hypothesis that a Combined Treatment strategy, integrating medication & psychosocial components, is significantly more effective in producing long-term therapeutic gains and preventing new psychopathology than Medication or Psychosocial Treatment alone, and that the difference is clinically meaningful. Continuation Aim 2 is to conduct confirmatory tests of the hypothesis that systematic, intensive treatments (all 3 MTA treatments) are significantly more effective (statistically and clinically) in producing long-term therapeutic gains and preventing new psychopathology than treatments typically received in the community. Continuation Aim 3 is to conduct confirmatory tests of the hypothesis that systematic, state- of-the-art treatments for ADHD in early childhood alter the risk for subsequent patterns of substance use and abuse, and that the risk alteration is clinically significant. Continuation Aim 4 is to conduct exploratory analyses to determine whether pre-treatment individual differences (severity, comorbidity, parent functioning, family history) are associated with patterns of stability/change in treatment effects. Continuation Aim 5 is to conduct exploratory analyses to determine the extent to which patterns of stability/change in therapeutic attitudes, attributions, philosophies, and treatment-related behaviors vary as a function of randomly assigned treatment, pre-post-treatment differences in functioning, post-treatment reports of satisfaction, and preexisting characteristics.

DESCRIPTION (Adapted from Applicant's Abstract): This Competing Continuation application requests funding for Years 07 to 11 of the NIMH collaborative Multimodal Treatment Study of Children with Attention Deficit Hyperactivity disorder (MTA Study). In a parallel group design, 579 rigorously diagnosed children with ADHD age 7-9 were randomly assigned to four treatment conditions: (1) Medication-only ; (2)Psychosocial-only; (3) Combined (medication and psychosocial); (4) Assessment-and-Referral condition. All but the latter were treated intensively for 14 months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original MTA design thus provides short-term (10 months post-treatment) follow-up at 24 months. Additional funding during Year 06 supported the collection of a local Normative Comparison Group (LNCG) drawn from the same schools as ADHD children. This Continuation would extend the follow-up to assessments at 36-, 60-, and 84 months after treatment. Continuation Aim 1 is to track the persistence of intervention-related effects as the MTA sample matures into mid-adolescence, including subsequent mental-health and school-related service utilization patterns as a function of MTA treatment experience (treatment assignment) and outcome (degree of treatment success at 14 mo.). Aim 2 is to test specific hypotheses about predictors, mediators, and moderators of long-term outcome among children with ADHD (e.g., comorbidity; family functioning; cognitive skills; peer relations) that may influence adolescent functioning (either independently of or through initial treatment assignment and/or 14-month treatment outcomes); and to compare how these predictors, and moderators are similar or dissimilar within the LNCG. Aim 3 is to track the patterns of risk and protective factors (including their mediation or moderation by initial treatment assignment and/or outcome) involved in early and subsequent stages of developing substance-related disorders and antisocial behavior. Aim 4 is to examine the effect of initial treatment assignment and degree of treatment success on later academic performance, achievement, school conduct, tendency to drop out, and other adverse school outcomes.

DESCRIPTION (provided by applicant): Numerous studies have examined the short-term efficacy of psychostimulant medication and behavior modification (the two evidence-based treatments) in the treatment of ADHD, but insufficiencies in acute effects of both treatments have been noted, leading to the widespread use of the combination of the two approaches. However, the combined approach to treatment has not yet been extensively studied in either short- or long-term evaluations. Numerous critical issues regarding ADHD treatment remain unresolved. A primary unresolved issue is how the intensity or dose of behavioral and pharmacological treatments and their combination influence the results of comparative efficacy studies. One of the major supporting arguments that proponents of combined treatments have made is that combining treatments enables the use of lower doses of medication and less intensive behavioral treatment relative to unimodal treatments; however, this concept has not been empirically studied in a well-controlled trial. The purpose of the proposed study is to examine the relative effects of and interactions between different doses of behavioral (none, low, and high) and pharmacological treatments (pl, .3mg/kg, and .6mg/kg) for ADHD by evaluating their separate and combined effects in a controlled summer program setting. The following specific aims are addressed: 1) Do combined treatments have incremental efficacy beyond their components, and does the answer to this question vary with the dose/intensity of the behavioral treatment and the dose of medication; 2) Do the answers to question 1 depend on domain of functioning (e.g., peer relationships, academic functioning, disruptive behavior, interactions with adults); 3) Do the answers to question I depend on the setting in which effects are assessed (i.e., recreational settings with peers, classroom settings, home/family settings); 4) How do individual difference variables (i.e., age. gender, severity of impairment, comorbid child diagnoses, family and parent characteristics) influence the answers to questions addressed above and; 5) What are the impacts of different intensities of behavioral, pharmacological, and combined treatments on parent, teacher, and counselor affect, stress, effort, and satisfaction with treatment? These questions will be answered in a within-subject investigation with 144 ADHD children between the ages of 5 and 12 in which each child receives all conditions. We will employ a variety of ecologically valid measures of functioning in a summer treatment program setting that has been well studied with respect to both behavioral and pharmacological treatments and allows precise of treatment fidelity and objective outcomes. Treatment effects will be analyzed at both the group and child level.

DESCRIPTION (provided by applicant): This competing renewal application requests funding for Years 8-12 to continue study of the onset, course, causes, and consequences of drug use and drug use disorders in The Pittsburgh ADHD Longitudinal Study (PALS). 364 children with ADHD (probands) were ascertained in their elementary school-aged years following their participation in the ADHD Program at WPIC, University of Pittsburgh. This is the largest study of its kind: rigorously diagnosed ADHD in childhood, detailed comprehensive childhood data (including standardized and objective data on both symptoms and impaired functioning in multiple domains), and detailed annual follow-up assessments of drug abuse and dependence and related domains (e.g., academic/vocational functioning, social relations, parent characteristics). NonADHD, demographically similar controls (n=240) were recruited at follow-up initiation, when participants were 11 to 25. Using a cohort-sequential design, all participants have been followed annually since recruitment;retention is over 90% and a multiple reporter approach has been adopted throughout. A sampling of findings includes: 1) earlier start of use and a higher risk for heavy marijuana and cigarette use in proband adolescents;2) absence of proband-control differences for marijuana use and disorder at 18-25 yrs when controls are also using marijuana heavily (unless concurrent ASP is considered);3) positive association between duration of lifetime stimulant treatment and early adulthood marijuana and cigarette use, 4) weak associations between childhood conduct problems and later drinking outcomes but strong concurrent associations, supporting an ADHDFconductFSUD pathway, and 5) considerable evidence of family adversity and poor school functioning in the probands. Continued follow-up (annual to age 25, age-targeted periodic assessments thereafter) is requested to determine whether early drug use patterns persist through the twenties when desistance is the U.S. norm, to determine whether new cases of SUD, particularly of non-marijuana illicit drugs, which have low rates in our participants to date, develop in the mid-to-late 20s, and to study the putative causal mechanisms underlying these SUD developments and consequences in early adulthood. PUBLIC HEALTH RELEVANCE: This is a large long-term study of drug use and dependence in people who were diagnosed with Attention- Deficit/Hyperactivity Disorder (ADHD) in childhood and will help explain why children with ADHD are at risk of drug use and dependence, including what factors contribute to the risk and what factors decrease the risk. ADHD is one of the most frequently diagnosed mental health problems of children in the United States;drug use and dependence risk in these individuals carries large direct and indirect costs to society. This study will provide information to improve prevention as well as treatments for drug use problems in this large group of high risk children in the U.S.

DESCRIPTION (provided by applicant): The following project is a supplement to the funded application "ADHD Treatment: Comparative and Combined Dosage Effects (1 RO1 MH62946 01A1)." The parent grant funds an investigation of behavioral, stimulant, and combined treatment for ADHD. This supplement allows for the collection of normative information. Normalization of functioning has become an important yardstick in evaluating clinically meaningful and socially valid treatment results. By contrasting ADHD and comparison children we will be able to evaluate normalization effects of the three interventions in the parent grant-behavioral, stimulant, and combined treatments. We will also validate two measures of impairment within the context of the treatment study. No scale has been developed that is clinically useful and cost-effective for the regular repetitions required in measuring target outcomes in impairment and its reciprocal-adaptive functioning, We propose to evaluate in the context of the parent treatment study two measures of impairment for assessing treatment outcome: (1) the Impairment Rating Scale measures problems in daily life functioning and need for treatment as rated by parents, teachers, and clinicians across functional domains; and (2) the Functional Improvement Ratings (FIR) are domain specific clinical global impressionof improvement (CGI-I) in the child's functional impairments, competencies, and skills. The validity of these two ratings as indices of treatment effects will be investigated within the parent grant in which treatments will be manipulated and measured across multiple settings, domains, and sources. The following specific aims will be addressed: Do behavioral interventions, stimulant medication, and combinations of the two normalize functioning of ADHD children? Are cost effective measures of impairment sensitive to treatment effects (i.e., varying intensities and combinations of behavior modification and stimulant medication), and does sensitivity depend on the domain of impairment or the setting in which symptoms/ impairment is measured (e.g., recreational, classroom, and home settings) or individual differences (e.g., age)? Do measures of impairment offer unique variance in measuring treatment outcome above measures of DSM symptoms when normalized functioning is the gold standard?

DESCRIPTION (provided by applicant): The number of children being treated with psychostimulant medication for ADHD has been increasing dramatically for a decade. Although also an evidence-based treatment, behavior modification is not as widely recommended. Primary questions are whether medication is needed by all of the children who take it, whether this need could be reduced if behavioral treatments were employed first, and whether the required dosage varies as a function of the presence of and intensity of behavioral treatments. In an ongoing funded NIMH study, we are examining the relative effects of and interactions between different doses of behavioral (none, low, and high) and pharmacological (pl, .15, .3, and .6 mg/kg MPH t.i.d.) treatments for ADHD children by evaluating their separate and combined effects in a controlled summer program (STP). Our preliminary results (1/3 of the Ss) suggest that average total daily dose of MPH can be reduced from 60 mg to 10-20 mg, depending on the concurrent behavioral treatment. Follow-up in the subsequent school year has shown that the need for medication in both the school and home settings is eliminated for many children if behavioral intervention is provided first. Given recent societal concerns about medication use especially in young children and growing concerns about long-term side effects and the absence of beneficial long-term effects, these findings may have great public health importance. The current application seeks to extend the results from our efficacy study to a regular school setting. We have chosen to concentrate on early school years, in a sample of children who are not yet medicated for ADHD, examining whether ongoing behavioral treatment can reduce the need for medication in those children. Children will begin the study assigned to no, low, or high behavior modification conditions in their regular home and school settings. Children's functioning will be assessed weekly, and medication will be added to their treatment regimen when functioning deteriorates to a predefined level. Because treatment for ADHD must be chronic, treatment will continue at the assigned level for a period of 3 years, with a 1-year follow up at the conclusion of treatment. Beyond current functioning, primary dependent measures will be the length of time survived without medication, medication dose as a function of behavioral treatment level, and costs of treatments. Individual differences including child, family, and teacher characteristics will be examined.

For both parents and educators, monitoring and adjusting their behaviors to ensure that children develop appropriate prosocial and learning behaviors is a complex balance between nurturance and limit setting. When these interactions are strained, negative or coercive cycles may emerge that delay appropriate development and exacerbate existing impairment. To disrupt the development of coercive cycles, adults must have the ability to accurately assess the quality of their interactions with children and integrate this information into personal change. Approaches to measuring these types of interactions will inform what we know about the mechanisms of child social, emotional, and learning development in STEM learning settings, and enable the creation of adaptive interventions for those moments when support is most needed. This project envisions a closed-loop intervention framework to promote a supportive and interactive environment around children. Smart wearables will sense interaction and responses between the children and their parents or educators, using embedded machine learning technology to recognize supportive behaviors. The perceived behaviors will be sent to a cloud server where adaptive interaction strategies will be identified from either online psychological consultation or artificial intelligence. These interaction strategies will then be provided to the parents and educators in the form of guidance cues to promote a supportive STEM learning environment around the children.

This planning project aims to understand the barriers and critical problems in the implementation of smart technology and psychological strategies to support adult-child interactions in STEM learning settings. The work will proceed by convening key stakeholders (parent organizations, formal educational institutions, and informal educational institutions) in a series of iterative discussions to produce a set of adult-child behavioral targets that are essential to children’s development of social, emotional, and learning skills. Further discussions will then identify mechanisms to enhance these behaviors, and reduce competing, less effective approaches. Qualitative thematic analysis of the discussions will be used to capture these behaviors and mechanisms. Then technologies will be developed to measure, provide feedback on, and improve these behaviors. These devices will be piloted with adult-child dyads. Audiovisual data collected by the devices will be human coded as well as processed by algorithms to vet the technological capacity of the devices to detect and respond to targeted behaviors. A series of debriefing interviews and surveys with adult-child dyads will be used to determine the feasibility, acceptability, and utility of the devices. The collected preliminary data will support the forming of critical technological and social science research questions that co-inform one another: questions about the social engagement between adults and children will drive the technical research, and what can be discovered via the technological research will open up new questions that can be posed about social engagement between children and adults. Adult-child interactions are key social factors that integrate to produce student social, emotional, and academic outcomes. Within our informal educational communities, our formal educational communities, and our familial communities it is essential to find the best mechanisms for measuring, providing feedback, and improving these interactions. This work thus seeks to advance a new approach to, and evidence-based understanding of, the development of STEM learning. This Smart and Connected Communities project is also supported by the Advancing Informal STEM Learning program, which seeks to (a) advance new approaches to and evidence-based understanding of the design and development of STEM learning in informal environments; (b) provide multiple pathways for broadening access to and engagement in STEM learning experiences; (c) advance innovative research on and assessment of STEM learning in informal environments; and (d) engage the public of all ages in learning STEM in informal environments.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.