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Medications in Young Children: Evidence, Best Practices, and Getting there from Here. Peter S. Jensen, MD President & CEO. The REACH Institute Co-Chair, Division of Child Psychiatry & Psychology The MAYO CLINIC. Evidence for Medications in C&A Disorders. STRONG. ADHD Stimulants TCAs

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peter s jensen md president ceo

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

slide2

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
slide3

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

slide4

% “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

slide5

14-Month Outcomes Teacher SNAP-Inattention

Average Score

Assessment Point (Days)

would you recommend treatment parent
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%

slide7

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

case study new york times 2007 carey
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
trends over time in preschool prescribing
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
case example adhd in preschoolers
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)
pats the preschool adhd treatment study
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
pats the preschool adhd treatment study12
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
pats the preschool adhd treatment study13
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
other preschool adhd studies
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
preschool adhd therapy studies
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)
guidelines relevant medication use in preschoolers
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
guidelines relevant to medication use in preschoolers
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
guidelines relevant to medication use in preschoolers20
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
guidelines relevant to medication use in preschoolers21
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
guidelines relevant to medication use in preschoolers22
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
guidelines relevant to medication use in preschoolers23
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
guidelines relevant to medication use in preschoolers24
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
the problem
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
effective provider organizational interventions
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

dissemination and adoption of new interventions
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
implications re changing provider behaviors
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
end result families not getting the evidence based assistance they need
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
manpower problems
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
quality problems
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
slide32

Accelerating this process:

The REsource for Advancing Children’s Health:

The REACH Institute

the reach institute putting science to work
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
training in what
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
training but how
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
reach approach a 4 step process

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
training approach
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
training benefits
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
example 1 primary care providers best practices
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.”

example 2 helping therapists apply ebps
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
reach s integrated psychotherapy consortium
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
the reach integrated psychotherapy approach
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
slide44

Begin

Aggression

PTSD

Depression

Anxiety

Optional Sessions

Termination Session

End

common techniques to aid in training and clinical applicability
Common techniques to aid in training and clinical applicability
  • Problem solving
  • Social skills
  • Family sessions
  • Setting goals
  • Organizational skills
session markers
Session Markers

5 minutes

Timed Section

Exercise

Graphic

Also sample language, session goals

example 3 engagement training
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!
example 4 parent empowerment training
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
examples of parent activities
Examples of Parent Activities
  • Learning about specific disorders and their evidenced-based treatments
  • How to keep a mental health “notebook” for your child
  • How to respond assertively to your child’s clinician
example 5 school interventions
Example 5: School Interventions

Focused on Improved Academic and School Behavior Outcomes

  • Guided, created and delivered by national team of educational and mental health experts
  • School-wide approaches, such as training in optimal classroom behavioral management, social-emotional curricula, violence prevention, and anti-bullying programs
  • Programs to help school staff identify and effectively help children with MH needs
  • Training in CBT and latest MH therapies
mh services reform strategic issues
MH Services Reform: Strategic Issues

Training, TA, & Time

Training, TA, & Time

Training, TA, & Time

science based plus necessary abilities
Science-based Plus Necessary “-abilities”
  • Palatable (acceptable to families and clinicians)
  • Affordable
  • Transportable
  • Trainable
  • Adaptable, Flexible
  • Evaluable
  • Feasible
  • Sustainable
mh services reform strategic issues55
MH Services Reform: Strategic Issues
  • Leadership, trust, engagement, and therapeutic alliance factors critical at all levels of “the system”
  • Begin with the end in mind: establish and ensure necessary “abilities” at all 3 levels
  • Enemy of the good is the perfect: raise the floor, not the ceiling
  • Win-win strategies
  • ”Buy-in” -- partnership, not ownership
mh services reform next steps
MH Services Reform: Next Steps
  • Evidence Based Guidelines
    • Child/Youth Empowerment and Support
    • Parent Empowerment and Support
    • MH Screening and Assessment
    • Psychosocial Interventions
    • Psychopharmacologic Standards and Procedures
  • EB Training – sufficient to produce & sustain behav change in clinicians and systems, and parents to become “agents of change”
  • WWW.TheREACHInstitute.org
  • PeterJensen@TheREACHInstitute.org
slide57

The REACH Institute

REsource for Advancing Children’s Health