Peter S. Jensen, MD President & CEO

1. Medications in Young Children: Evidence, Best Practices, and Getting there from Here Peter S. Jensen, MDPresident & CEO The REACH Institute Co-Chair, Division of Child Psychiatry & Psychology The MAYO CLINIC

2. Evidence for Medications in C&A Disorders STRONG • ADHD Stimulants • TCAs • ATX MODERATE • DEPRESSION SSRIs • AUTISM Antipsychotics • OCD SSRIs, TCAs • ODD/CD/Agg Antipsychotics, Mood stabilizers, Stimulants • ANXIETY SSRIs • BIPOLAR/SZ Atypicalss WEAK • BIPOLAR Lithium • TOURETTE’S Antipsychotics

3. Barriers vs. “Promoters” to Delivery of Effective Services (Jensen, 2000) Three Levels: Child & Family Factors: e.g., Access & Acceptance Provider/Organization Factors: e.g., Skills, Use of EB Systemic and Societal Factors: e.g., Organiz., Funding Policies EfficaciousTreatments “Effective” Services

4. % “Normalized” at 14-month EndpointMTA Groups vs. Classroom Controls 88% 68% 56% 34% 25% MTA N = 579, Classroom Cntrls N = 288 1. MTA Co-operative Group Arch Gen Psychiatry 1999 56: 1073–1086

5. 14-Month Outcomes Teacher SNAP-Inattention Average Score Assessment Point (Days)

6. Would You Recommend Treatment? (parent) Medmgt Comb Beh Not recommend 9% 3% 5% Neutral 9% 1% 2% Slightly Recommend 4% 2% 2% Recommend 35% 15% 24% Strongly recommend 43% 79% 67%

7. Teacher-Rated Inattention(CC Children Separated By Med Use) Key Differences, MedMgt vs. CC: Initial Titration Dose Dose Frequency #Visits/year Length of Visits Contact w/schools

8. Case StudyNew York Times, 2007 (Carey) • 4 year-old girl • ADHD + Bipolar diagnosis age 2 • Seroquel (atypical AP) • Depakoate (mood stabilizer/seizure agent • Clonidine • No studies of any of these agents in children under age 6

9. Trends over Time in Preschool Prescribing • Minde, 1997: US and Canada • 3-fold increases in Methylphenidate • 10-fold increases in SSRIs • Zito 2000 • State Medicaid claims, 2 states • 1.5% of children ages 2-5, significant increases over time • 28-fold increases in clonidine • 3-fold increases in MPH • Recent increases in atypicals in preschoolers • Majority of preschool meds – stimulants • Most preschoolers w/behavior problems get therapy only

10. Case Example:ADHD in Preschoolers • DSM-IV criteria same in younger children • Triad of impulsivity, inattention, hyperactivity • Developmental considerations • Clinical presentation • Frequent comorbidity (74%) – Wilens et al., 2002) • CD, ODD, Anxiety • Only 19% received services (Pavuluri et al., 1996)

11. PATS: The Preschool ADHD Treatment Study • Only one dozen small trials in preschool children, total N = 417 (Ghuman et al., 2008) • Variable results, increased side effects • Sadness, irritability, clinging, insomnia, anorexia • PATS intended to fill the gap of information in a sufficiently large trial

12. PATS: The Preschool ADHD Treatment Study • 8 phase study, 70 weeks • 303 preschool children ages 3-5.5 yrs • All began with 10 week group parent training • 70% comorbidity • Increased ADHD severity linked to anxiety, depression • Non-responders eligible for next phase (MPH), N = 165 • Graduated dose-response, 14.2mg/day MPH

13. PATS: The Preschool ADHD Treatment Study • 2.5, 5, and 7.5mg given t.i.d. • Effect sizes smaller than older children • Less weight gain -1.32 kg/year among medicated children • Less height gain -1.38 cm/year among medicated children • No serious side effects • Irritability, outbursts, DFA, reduced appetite • Slower renal clearance than older children • Multiple comorbidities – little or no response • 140 children complete 10 months, 45 discontinue meds

14. PATS: The Preschool ADHD Treatment Study

15. PATS: The Preschool ADHD Treatment Study Study month

16. Other Preschool ADHD Studies • Atomoxetine (Strattera) open study given to 22 5-6 year olds • Apparent benefits, 1.25mg/kg/day • No serious side effects • Role of psychosocial treatments paramount • Possible benefit of combination approaches, especially innovative new therapy approaches • Some evidence for dietary approaches

17. Preschool ADHD Therapy Studies • Family factors critical to ADHD outcomes • Negative or inconsistent parenting, harsh discipline, or high levels of family adversity • However, only 7.2% of 261 PATS families benefited significantly from PT alone • Home-based parent training using innovative approaches more effective than medication at 1 year (Sonuga-Barke et al., 2001)

18. Guidelines Relevant Medication Use in Preschoolers • Practice Parameters for Psychiatric Assessment of Infants & Toddlers (AACAP, 1997) • Establishing a working alliance • Reasons for referral • Developmental history • Family relational history • Clinical observation • Standardized tools • Mental status exam • Interdisciplinary assessment & referral • Diagnostic formulation • Treatment planning

19. Guidelines Relevant to Medication Use in Preschoolers Practice Parameters for Use of Psychotropic Medications in C&A (AACAP, 2009) • Before starting meds, do complete psychiatric evaluation • Before starting meds, do med Hx and evaluation • Communicate w/other professionals to plan/coordinate care • Develop psychosocial and pharmacologic treatment plan • Develop/implement short- and long-term monitoring plan • Be cautious when implementing plan that can’t be monitored

20. Guidelines Relevant to Medication Use in Preschoolers Practice Parameters for Use of Psychotropic Medications in C&A (AACAP, 2009) (continued) • Complete and document assess and consent • Discuss risks and benefits • Use adequate dose and duration • Reassess for incomplete or non-response • Provide clear rationale for medication combinations • Discontinuation requires clear plan

21. Guidelines Relevant to Medication Use in Preschoolers • Psychopharmacologic Treatment for Very Young Children Contexts and Guidelines (Gleason et al., 2007) • Avoid meds when therapy is likely to be helpful • Precede meds with an adequate trial of therapy • Continue psychotherapy even when meds are used • ADHD Algorithm stages • STAGE 0 DIAGNOSTIC EVAL AND THERAPY TRIAL • STAGE 1 PHARMACOLOGIC TRIAL (MPH) • STAGE 2 AMPHETAMINE TRIAL • STAGE 3 ALPHA AGONIST OR ATOMOXETINE

22. Guidelines Relevant to Medication Use in Preschoolers • Psychopharmacologic Treatment for Very Young Children Contexts and Guidelines (Gleason et al., 2007) • DISRUPTIVE DISORDER Algorithm stages • STAGE 0 DIAGNOSTIC EVAL • STAGE 1 NON-PHARMACOLOGIC INTERVENTIONS • STAGE 2 RISPERIDONE TRIAL, CONTINUE THERAPY • DEPRESSIVE DISORDER Algorithm stages • STAGE 0 DIAGNOSTIC EVAL • STAGE 1 NON-PHARMACOLOGIC INTERVENTIONS • STAGE 2 SSRI TRIAL(S), CONTINUE THERAPY

23. Guidelines Relevant to Medication Use in Preschoolers • Psychopharmacologic Treatment for Very Young Children Contexts and Guidelines (Gleason et al., 2007) • BIPOLAR DISORDER Algorithm stages • STAGE 0 DIAGNOSTIC EVAL • STAGE 1 NON-PHARMACOLOGIC INTERVENTIONS • STAGE 2 MEDICATION TRIAL(S), CONTINUE THERAPY • NOT RECOMMENDED: MEDS W/O THERAPY • ANXIETY DISORDER Algorithm stages • STAGE 0 DIAGNOSTIC EVAL • STAGE 1 NON-PHARMACOLOGIC INTERVENTIONS • STAGE 2 FLUOXETINE TRIAL, CONTINUE THERAPY • STAGE 3 FLUVOXAMINE TRIAL, CONTINUE THERAPY

24. Guidelines Relevant to Medication Use in Preschoolers • Psychopharmacologic Treatment for Very Young Children Contexts and Guidelines (Gleason et al., 2007) • PDD DISORDERS Algorithm stages • STAGE 0 DIAGNOSTIC EVAL • STAGE 1 NON-PHARMACOLOGIC INTERVENTIONS • STAGE 2 MEDICATION TRIAL(S), CONTINUE THERAPY • SLEEP DISORDERS Algorithm stages • STAGE 0 DIAGNOSTIC EVAL • STAGE 1 NON-PHARMACOLOGIC INTERVENTIONS • STAGE 2 MELATONIN TRIAL, CONTINUE THERAPY • STAGE 3 CLONIDINE TRIAL, CONTINUE THERAPY

25. The PROBLEM: • Desperate parents & preschools • Limited resources • Need for effective education of providers • Current CME methods ineffective • Educational materials (e.g., distribution of recommendations for clinical care, including practice guidelines, AV materials, and electronic publications) • Didactic educational meetings

26. Effective Provider & Organizational Interventions: • Educational outreach visits • Reminders (manual or computerized) • Multifaceted interventions • Sustained, interactive educational meetings (participation of providers in workshops that include discussion and practice) Bero et al, 1998

27. Dissemination and Adoption of New Interventions • Sustained Interpersonal contact • Organizational support • Persistent championship of the intervention • Adaptability of the intervention to local situations • Availability of credible evidence of success • Ongoing technical assistance, consultation

28. Implications re: Changing Provider Behaviors • Changing professional performance is complex - internal, external, and enabling factors • No “magic bullets” to change practice in all circumstances and settings (Oxman, 1995) • Multifaceted interventions targeting different barriers more effective than single interventions (Davis, 1999) • Consensus guidelines approach necessary, but not sufficient. • Lack of fit w/HCP’s mental models

29. Many proven treatments now available but… Information is not getting to families, health care providers and schools It takes anywhere from 15-20 years for a proven intervention to reach a PCC who will use it to treat your child Information and assistance needs to be Family friendly Guided by family input and experience Science-based Practical and hands-on End Result: Families not getting the evidence-based assistance they need

30. Scarcity of Child Psychiatry Boutique practices Differences in care based on ability to pay Pseudo-Stradavarius model vs. High quality production model 6000 CAPs, 5000 active, for 7 million children: 1,400 children per CAP, vs. 50-200 seen per year 10 hours/year spread across 2000 hours = 200 children Only 1 in 7 children seen by CAPs -- 14%. If all CAPs time were spread equally across all children in need = 1.5 hours child… (four 15’ med-checks/year) Alternatives? Manpower Problems

31. Diagnostic practices Unreliability of individual clinicians Variabilty of diagnostic and treatment practices 8-fold increases in bipolar Polypharmacy Lack of dissemination of EBPs (Evidence-based practices) Failure to use EBAIs(evidence-based assessments & interventions) Novice families don’t know how to discriminate quality! Relationship key, but only partial indicator of quality Alternative Solutions? Quality Problems

32. Accelerating this process: The REsource for Advancing Children’s Health: The REACH Institute

33. The REACH Institute ~ Putting Science to Work ~ The Institute was established in the spring of 2006 to accelerate the acceptance and effective use of proven interventions that foster children’s emotional and behavioral health. REACH fills a uniquerole by: • Promoting a family-oriented approach to mental health care • Developing partnerships with parents, pediatricians, APRNs, schools, and others to apply best practices and proven interventions • Providing “hands-on” assistance to partners • Focusing on Key Disorder Areas

34. Training in What? • Parent/Family Level: Parent Facilitators • Clinician Level: Increasing positive and/or proven practices, reducing potentially harmful, unnecessary/expensive practices • Brief Psychotherapy manuals and training on treatment for anxiety, depression, trauma, and conduct problems • Pediatric Psychopharmacology Mini-fellowship • Engagement training • EB Assessments/Diagnosis • Systems Level: consultation & reorganization

35. Training, But How? • CME and “hit and run” workshops generally ineffective • Training needs to address issues and obstacles that are likely to be encountered at ALL THREE levels • Collaborative learning partnership approaches, vs. one-down relationships

36. Recommended methods for assisting health care staff in adopting EBPs

37. Step 1 Step 2 • Identify and Validate • Identify key problem areas w/partners • Obtain consensus & commitment on the latest, most effective interventions derived from rigorous research • Adapt • Make interventions “user-,” “patient-” and “family-friendly” • …so they can be readily applied by patients, families, and health care professionals Step 4 • Empower • Strategic partners carry forward the mission to their own organization members, to enable proven interventions to reach the most kids in the shortest time Step 3 • Distribute, Apply and Evaluate • Use strategic learning partnerships • Reach as many children as possible in a credible and effective way • Evaluate, feed results back into Step 2 REACH Approach: A 4-step process

38. Training Approach • Hands-on, with role plays and extensive practice • Can be done “on-site” or at national locations • 2 day’s face-to-face training with 15-30 clinicians, with 2-3 trainers, followed by: • 6 months of twice-monthly phone call consultation and support, 1-1.5 hours/call • Individual case presentations, with peer learning

39. Training Benefits • Graduates report improved staff morale, decreased staff burn-out and turn--over • Risk management & quality assurance • Decreased no-show rates, improved billing • Increased treatment efficacy and improved family/student/client satisfaction • Enhanced value-added of current services • “Excellence” certificates for clinicians & educators after completing training

40. Deliver family-centered, effective care Assist pediatricians and family practitioners to manage youth depression and suicide risk Help doctors in managing treating ADHD and Depression, and avoiding over-diagnosis Help doctors get the right information to patients and families Pediatric Psychopharmacology Program – A “Mini-Fellowship” 6 months’ training and support Example 1: Primary Care Providers: “Best Practices” Partner with doctors and APRNs to identify and implement “Best Practices.”

41. Example 2: Helping Therapists Apply “EBPs” Training Partnerships with counselors and psychotherapists to apply CBT, IPT, Engagement Strategies, BT • Uniform ‘look and feel’: same introduction, supporting documentation (CBT) and introductory session. • Manuals share similar session structure, graphics and session markers • One year of supervision • Organizational Partnership • Evaluation Partnership

42. REACH’s Integrated Psychotherapy Consortium • Anxiety: Tom Ollendick, Ron Rapee, Wendy Silverman • Depression: Kevin Stark, John Curry • Disruptive: John Lochman, Karen Wells • PTSD: Chris Layne, William Saltzman • Consultant: Bruce Chorpita • REACH Institute: Peter Jensen, Eliot Goldman, Kimberly Hoagwood

43. The REACH - Integrated Psychotherapy Approach • Manuals originally developed for Project Liberty (mental health response to 9/11 trauma) • Intervention geared to children & adolescents with mild/moderate sx • 4 areas of intervention (anxiety, depression, disruptive & PTSD) • Adapted from evidence based tx developed by nationally recognized experts

44. Begin Aggression PTSD Depression Anxiety Optional Sessions Termination Session End

45. Common techniques to aid in training and clinical applicability • Problem solving • Social skills • Family sessions • Setting goals • Organizational skills

46. Session Markers 5 minutes Timed Section Exercise Graphic Also sample language, session goals

47. How are you feeling today ?

49. Example 3: Engagement Training • Explicit problem-solving approach applied by health care team concerning the family’s perceived obstacles to care • Tailoring to fit specific needs and family values • Respect of mutual expertise • Encouragement of ventilation of concerns & questions • Dramatic reductions in no-show rates • Increased effects with psychoeducation, also increased satisfaction and compliance • SAVES CLINIC AND CLINICIAN TIME!

50. Example 4: Parent Empowerment Training • Uses Professional Parent Advocates to model and teach parents how to navigate the system, advocate for their child, and get high quality evidence-based care • Promote parent/provider partnerships • Increase parent knowledge about mental health needs and evidenced based service delivery options • Increase parent self efficacy • Improve parent communication and assertiveness skills