This section provides guidance, resources, and tools to assist with implementing best practices for the safe and judicious use of antipsychotics in children and adolescents. It includes a structured approach to develop organizational readiness, as well as clinical capacity, for implementing best practices. This protocol can be tailored to specific needs, and is organized into five stages, with key activities and tools at each stage.
I. QI Best Practices for the Safe and Judicious Use of Antipsychotics in Children and Adolescents
Stage 1. Make the Case: Engage Key Stakeholders
Engaging key stakeholders and identifying champions is critical to facilitating the success of new interventions. Leadership support helps to prioritize target interventions, build organizational readiness, and carve out appropriate resources. Additionally, understanding the care experience from the youth and family perspective has the potential to significantly inform and enhance QI activities. By engaging youth and families in QI work, organizations can better understand what it takes for people to successfully navigate health services, make informed decisions, and coordinate among multiple providers to achieve desired health outcomes.
Step 1: Engage Senior Leadership in QI Work
- Webinar: Engaging Senior Leadership in Your Quality Improvement Work (National Institute for Children’s Health Quality, 2016).
- Webinar: How to Speak So Leaders Will Listen (Institute for Healthcare Improvement (IHI), 2019).
Step 2: Form a Team
- Handbook: Creating Quality Improvement Teams and QI Plans (AHRQ, 2013).
Step 3: Engage Youth and Family
- Journal Article: Patient And Family Engagement: A Framework For Understanding The Elements And Developing Interventions And Policies (Health Affairs, 2013).28
- Toolkit: Effectively Employing Young Adult Peer Providers (PDF) (University of Massachusetts Medical School, 2017).
- Webinar: Employing Young Adult Peer Support Workers (University of Massachusetts Medical School, 2017).
Example: One plan successfully engaged with a community partner to increase mental health awareness among members and to connect with individuals with lived experience to further help engage youth. Together, these organizations designed and implemented a successful back-to-school event, which included both social and educational components. The purpose of the event was to provide health education to members while also hosting activities such as face painting, dental screenings, and meditation classes. Health education information was provided via handouts (along with school supplies) to raise awareness of behavioral health services and specifically the importance of monitoring side effects when taking antipsychotic medications (i.e., need for lab testing). During preparation for the event, the community partner and a youth advisor provided feedback on the health education materials to ensure the content was relevant and clear for youth and their families. Feedback from the community was very positive; the goal is to leverage this partnership and develop materials for subsequent programming.
Stage 2. Assess & Build Organization Readiness for Change
It is important to understand an organization’s readiness for change before implementation efforts begin. Stage 2 helps to guide this assessment and plan for necessary changes related to QI efforts.
Step 1: Assess Readiness and Address Gaps with Stakeholders
- Fundamentals of Health Care Improvement: A Guide to Improving Your Patients' Care, Third Edition (Joint Commission Resources, 2018) (fee required).
Step 2: Develop Workflows
- Develop a workflow for practice preparation, identification, assessment, and initial management.
Step 3: Identify and Address Barriers
- As change efforts are rolled out, the QI team may encounter various barriers and challenges that will need to be addressed to continue implementation work. Engage leadership and champions to help overcome barriers. To facilitate ongoing success and address new challenges, continue to prioritize QI efforts with dedicated meetings and appropriate staff time allocations, as needed.
Step 4: Plan for Key Trainings
- Determine whether ample training time specific to staff involvement in the QI work has been allocated and whether key guidelines have been incorporated into training plans.
Stage 3. Build Infrastructure to Support Practice Change
In tandem with engagement efforts and organizational readiness assessment, building an infrastructure to support ongoing change efforts is also critical to successful implementation and sustainability.
Step 1: Build Staff Commitment and Efficacy
- To help drive continued and meaningful staff commitment, it may be helpful to frame new efforts as part of an organization’s overall goal or mission (e.g., commitment to providing the best care for the patient and their families, commitment to drive good outcomes). It can be helpful to provide other contextual information as extrinsic motivators (e.g., incentives, policies, comparisons, state of the art care, etc.).
Step 2: Leverage Existing Capacity with Plans to Support Change Efforts
- Determine how existing roles within an organization can be allocated to support each part of the QI work, including what existing resources can be used and what adequate referral networks are in place. In planning ahead, consider what infrastructure supports (e.g., registries, case managers, pharmacy staff) are available to assist change efforts.
Stage 4. Implement Best Practices
Step 1. Set Goals
- Establishing tangible goals is key to any QI initiative. To monitor success, choose a set of metrics to help assess goal realization and guide QI efforts. Teams, along with leadership, should identify priorities and measurable goals to understand if change ideas are leading to improvements.
- Science of Improvement: Setting Aims (IHI, 2020).
Step 2. Identify Key Drivers
- This toolkit highlights the use of the key drivers to achieving aims (refer to the Key Driver Diagrams section). QI teams can use driver diagrams to prioritize change ideas.
Step 3. Implement Change
- Depending on what the QI team prioritizes, there are a variety of change ideas that can be implemented that specifically target improvement in the safe and judicious use of antipsychotics in children and adolescents. For a full list of change ideas and resources, go to the Change Ideas sections of this toolkit.
- How to Improve (IHI, 2020). The Model for Improvement involves testing change ideas using Plan-Do-Study-Act (PDSA) cycles.
- PDSA Worksheet (IHI, 2020). This is a useful tool for documenting a test of change and can help leaders define the stages of a PDSA cycle.
Step 4. Use Youth/Family-Focused Best Practices
- Use youth and family advisors to select Change Ideas specifically focused on improving communication and care with youth that are on antipsychotics and their families.
Stage 5. Plan for the Future: Sustainability
Critical to ongoing success of implementation efforts is understanding when additional support is needed, and when to spread success.
Step 1: Develop a Sustainability Plan
- Planning for the Future: Developing a Sustainability Plan (Advancing Integrated Mental Health Solutions (AIMS) Center, 2019).
- The Program Sustainability Assessment Tool: A New Instrument for Public Health Programs (Centers for Disease Control and Prevention (CDC), 2014).
- Improvement Leaders' Guide: Sustainability (National Health Service (NHS) Institute for Innovation and Improvement, 2007).
Step 2: Spread Successful Efforts to Other QI Initiatives
- Tool: Spread Planner (IHI, 2020).
II. Guidelines and Recommendations for the Safe and Judicious Use of Antipsychotic Medications in Children and Adolescents
Recommendations Supporting Use of Psychosocial Interventions for Children and Adolescents
| Guideline (Date) | Population | Recommendation or Statement | Type/Grade |
|---|---|---|---|
| AACAP-AAA (2011) Practice parameter for the use of atypical antipsychotic medications in children and adolescents.18 |
5-18 years | “Prior to the initiation of and during treatment with an AAA, the general guidelines that pertain to the prescription of psychotropic medications should be followed… including education and psychotherapeutic interventions for the treatment and monitoring of improvement.” (Recommendation 1) | Clinical Standard |
| “In the absence of specific FDA indications or substantial evidence for effectiveness, physicians should consider other medication or psychosocial treatments before initiating antipsychotic treatment.” (Under Recommendation 2) | Clinical Standard | ||
| AACAP-BP (2007) Practice parameter for the assessment and treatment of children and adolescents with bipolar disorder.29 |
≤18 years | “Psychotherapeutic interventions are an important component of a comprehensive treatment plan for early-onset bipolar disorder.” (Recommendation 10) | Minimal Standard |
| AACAP-ODD (2007) Practice parameter for the assessment and treatment of children and adolescents with oppositional defiant disorder.30 |
≤18 years | “The clinician should develop an individualized treatment plan based on the specific clinical situation…. The two types of evidence-based treatments for youth with ODD are individual approaches in the form of problem solving skills and family interventions in the form of parent management training.” (Recommendation 7) | Minimal Standard |
| “The clinician should consider parent intervention based on one of the empirically tested interventions.” (Recommendation 8) | Minimal Standard | ||
| “Medications may be helpful as adjuncts to treatment packages, for symptomatic treatment, and to treat comorbid conditions.” (Recommendation 9) Supporting notes recommend that if medications are initiated, it should be after psychosocial interventions are in place, and that medications should not be the only treatment. “Several open and double-blind placebo-controlled studies show that typical and atypical antipsychotics are helpful in treating aggression after appropriate psychosocial interventions have been applied in the context of mental retardation and PDD.” (Under Recommendation 9) |
Clinical Guideline | ||
| AACAP-SZ (2001) Practice parameter for the assessment and treatment of children and adolescents with schizophrenia.31 |
≤18 years | “Adequate treatment requires the combination of psychopharmacological agents plus psychosocial interventions.” (Recommendations – Treatment) | Minimal Standard |
|
“The following psychosocial interventions are recommended:
|
Minimal Standard | ||
| “Specialized educational programs and/or vocational training programs may be indicated for some children or adolescents to address the cognitive and functional deficits with the illness.” (Recommendations- Psychosocial Interventions) | Clinical Guidelines | ||
| PPWG (2007) The AACAP-sponsored Preschool Psychopharmacology Working Group –Psychopharmacological treatment for very young children: contexts and guidelines.32 |
<6 years |
“Universal guidelines are provided to encourage careful and planful clinical practice:
|
(see diagnostic specific ratings) |
| ADHD: Parent Management Training or other behavioral intervention x eight weeks minimum is first line for preschoolers. | A (Preschool) | ||
| Disruptive behavioral disorders: Psychotherapy (e.g., Parent management training, parent child interaction therapy) x 10-20 weeks. | A (Preschool) | ||
| MDD: Psychotherapy is first line (e.g., dyadic psychotherapy, target emotional regulation) x three-six months. | C (Preschool) A (6-18yrs) |
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| BP: Psychotherapy is first line (e.g., dyadic psychotherapy, target emotional regulation) x eight-12 sessions | C (Preschool) A (6-18yrs) |
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| Anxiety (GAD, SAD, SM, SP): CBT is first line, x 12 weeks. | C (Preschool) A (6-18yrs) |
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| PTSD: Psychotherapy is first line (Child Parent Psychotherapy x six months minimum; or CBT x 12 weeks minimum; or, if unavailable, then Play therapy x months. | A (Preschool CPP, CBT) B (Preschool; Play therapy) A (6-18yrs, CBT) |
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| OCD: CBT with parent involvement, behavioral therapy x 12 weeks minimum. | C (Preschool) A (6-18yrs) |
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| PPD: Behavioral, developmental, psychoeducational intervention is first line. | A (Preschool and 0-18yrs) | ||
| Sleep: Parent education and sleep hygiene. | C (Preschool) A (6-18yrs) |
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| T-MAY (2012) Center for Education and Research on Mental Health Therapeutics – Treatment of maladaptive aggression in youth.33 |
≤18 years | “Provide or assist the family in obtaining evidence-based parent and child skills training during all phases of care.” (Recommendation 10) | Evidence: A Recommendation: Very Strong |
| “Engage the child and family in taking an active role in implementing psychosocial strategies and help them to maintain consistency.” (Recommendation 11) | Evidence: A Recommendation: Very Strong |
||
| “Recommendations 10 and 11 pertain to psychosocial interventions, which should be the first line of treatment because of its lower risk, preceding the use of medication to address aggression except in emergency circumstances…” (Under Treatment Recommendations – Unrated Explanatory Comment) | Not specified | ||
| TRAAY (2003) Center for the Advancement of Children’s Mental Health: Treatment recommendations for the use of antipsychotics for aggressive youth.34 |
≤18 years | Psychosocial and educational interventions should continue after medication treatment begins. | Not specified* |
*TRAAY (2003) did not specify the use of any rating system.
Recommendations for Metabolic Screening and Monitoring for Children and Adolescents on Antipsychotic Medication
| Guideline (Date) | Recommendation or Statement | Type/Grade |
|---|---|---|
| AACAP-AAA (2011) Practice parameter for the use of atypical antipsychotic medications in children and adolescents.18 |
“The acute and long-term safety of these medications in children and adolescents has not been fully evaluated and therefore careful and frequent monitoring of side effects should be performed… Ideally, monitoring of BMI, blood pressure, fasting glucose, and fasting lipid profiles should follow, whenever feasible, the recommendations found in the consensus statement put forth by the American Diabetes Association and American Psychiatric Association.” Table: Fasting plasma glucose – Baseline, 12 weeks, annually; Fasting lipid profile – Baseline, 12 weeks. (Recommendation 10 and Table 2) | Clinical Guideline |
| “Careful attention should be given to the increased risk of developing diabetes with the use of AAA, and blood glucose and other parameters should be assessed at baseline and monitored at regular intervals.” (Recommendation 12) | Clinical Standard | |
| “In those patients with significant weight changes and/or a family history indicating high risk, lipid profiles should be obtained at baseline and monitored at regular intervals.” (Recommendation 13) | Clinical Guideline | |
| AACAP-BP (2007) Practice parameter for the assessment and treatment of children and adolescents with bipolar disorder.29 |
“Psychopharmacological interventions require baseline and follow-up symptom, side effect, and laboratory monitoring as indicated…. The American Diabetes Association’s recommendations for managing weight gain for patients taking antipsychotics should be followed. This includes baseline BMI, waist circumference, blood pressure, fasting glucose, and a fasting lipid panel. The BMI should be followed monthly for 3 months and then quarterly. Blood pressure, fasting glucose, and lipids should be followed up after 3 months then yearly.” (Recommendation 8) | Minimal Standard |
| AACAP-SZ (2001) Practice parameter for the assessment and treatment of children and adolescents with schizophrenia.31 |
“The use of antipsychotic agents requires…. documentation any required baseline and follow-up laboratory monitoring...” | Minimal Standard |
| CAMESA (2011) Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in Children – Evidence-based recommendations for monitoring safety of second generation antipsychotics in children and youth.35 |
The guideline provides antipsychotic medication-specific recommendations for monitoring physical examination maneuvers (height, weight, BMI, waist circumference, blood pressure, and neurological examination for extrapyramidal symptoms), and laboratory tests (glucose, insulin, lipid profile tests, AST, ALT, prolactin, and TSH) for children on AAAs. The GRADE rating system is used to rate each test, for each medication, at each time point examined (baseline, three, six, and 12 months). In recognition that clinicians may not have the resources to apply drug specific recommendations, the guideline developers also created a simplified version of the recommendations. Summary recommendation: All children prescribed AAAs should be monitored for metabolic side effects at baseline, three, six, and 12 months with the following tests: fasting glucose, fasting insulin, and fasting lipid profile (total cholesterol, LDL, HDL, TG). (Note: Fasting insulin is not recommended for youth on aripiprazole but is appropriate for all other AAAs). |
Ranges from 1A (strong) to not recommended depending on the specific medication, laboratory test, and timeframe. Strongest evidence and recommendations are for baseline tests. |
| A baseline fasting glucose is recommended for all children and adolescents on AAAs (strong recommendation/low quality evidence all AAAs except Ziprasidone, weak recommendation/ consensus based). | 1C (all AAA except Ziprasidone) 3 (Zip=3) |
|
| A baseline fasting lipid profile is recommended for all children and adolescents on AAAs (strong recommendation with high to low evidence depending upon the AAA, except Ziprasidone, weak recommendation/consensus based). | 1A-1C (all AAAs except Ziprasidone) 3 (Zip=3) |
|
| A follow-up fasting glucose and fasting lipid panel (one or more of the tests within the panel) is strongly recommended for all children at one or more time points during the year. (strong recommendation/high-moderate-low evidence for all AAAs, except Ziprasidone, weak recommendation/consensus based). | 1A-1C (all AAAs except Ziprasidone) 3 (Zip=3) |
|
| PPWG (2007) The AACAP-sponsored Preschool Psychopharmacology Working Group – Psychopharmacological treatment for very young children: contexts and guidelines.32 |
“Use of AAA should follow the AACAP practice parameter on AAAs. This practice parameter describes the minimum standards for monitoring vital signs, BMI, fasting blood glucose, extrapyramidal symptoms, lipid profiles, and electrocardiography.” (Disruptive Behaviors Algorithm, Stage 2: Pharmacological Intervention) | Not specified |
| T-MAY (2012) Center for Education and Research on Mental Health Therapeutics – Treatment of maladaptive aggression in youth.33 |
Practitioners should conduct appropriate, guideline-based laboratory monitoring. | Evidence: A Recommendation: Very Strong |
| TX (2010) Texas Department of Family and Protective Services – Psychotropic medication utilization parameters for foster children.36 |
Practitioners should document appropriate monitoring of laboratory findings. | Not specified* |
*TX (2010) did not specify the use of any rating system.
Grading System Key
| Guideline Developer | Definition |
|---|---|
| AACAP | Minimal Standard/Clinical Standard: Rigorous/substantial empirical evidence (meta-analyses, systematic reviews, RCTs) and/or overwhelming clinical consensus; expected to apply more than 95% of the time. |
| Clinical Guidelines: Strong empirical evidence (non-randomized controlled trials, cohort or case-control studies) and/or strong clinical consensus; expect to apply in most cases (75% of the time). | |
| Options: Acceptable but not required; there may be insufficient evidence to support higher recommendation (uncontrolled trials, case/series reports). | |
| Not endorsed: Ineffective or contraindicated. | |
| AACAP endorsed best practice principles | Best practice principles that underlie medication prescribing, to promote the appropriate and safe use of psychotropic medications. |
| CAMESA | GRADE37,38 |
| 1A: Strong recommendation, High quality evidence. | |
| 1B: Strong recommendation, Moderate quality evidence. | |
| 1C: Strong recommendation/ Low quality evidence. | |
| 2A: Weak recommendation, High or moderate quality evidence. | |
| 2B: Weak recommendation, Low quality evidence. | |
| 3: Weak recommendation, No evidence, consensus based. | |
| PPWG | A: Well controlled RCTs, large meta-analyses, or overwhelming clinical consensus. |
| B: Empirical evidence (open trials, case series) or strong clinical consensus. | |
| C: Single case reports or no published reports, recommendation developed by expert consensus (informal). | |
| T-MAY Ratings | Oxford Centre for Evidence-Based Medicine grade of evidence (A-D)39 |
| Strength of Recommendation: Very strong (≥90% agreement). | |
| Strength of Recommendation: Very strong (70-89% agreement). | |
| Strength of Recommendation: Very strong (50-69% agreement). | |
| Strength of Recommendation: Very strong (<50% agreement). |
