Weight Management Intervention for Youth and Young Adults With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      Psychotropic medications are the first-line treatment across several diagnostic categories
      encompassing severe mood disturbances and behavioral problems. The use of Second Generation
      Antipsychotics (SGAs) has increased in children with Autism Spectrum Disorder (ASD) in the
      last decade. However, SGAs are associated with serious metabolic side effects in youth that
      include cardiovascular disease, hypertension, and diabetes mellitus. This makes the public
      health impact of treating medication-induced metabolic disturbances almost as important as
      treating the mental illness itself. Improving health and reducing premature mortality in
      people with severe mental illness, the investigators propose to provide early weight
      management prevention, delivered by clinicians, for youth starting SGAs in order to target
      common modifiable health risk factors in the developmental process. This study will provide
      an urgently needed practical model for integrating weight management into academic- and
      community-based autism care.
    

Detailed description: 
      The innovations are four-fold: (1) adapting an evidence-based weight management treatment for
      youth/adolescents and young adults with Autism Spectrum Disorder (ASD); (2) training
      providers embedded within standard psychiatric care setting in an empirically-validated
      intervention for weight management; (3) utilizing a collaborative care model for weight
      management in psychiatric care for youth starting second generation antipsychotics (SGAs) to
      prevent/decelerate metabolic dysfunction; and (4) identifying factors that affect
      implementation into all Autism Treatment Network (ATN) sites. Given recent calls to move
      toward community-based obesity prevention approaches among high-risk youth, this study will
      provide an urgently needed intervention for adolescents and young adults with ASD on
      medications known to have untoward metabolic adverse effects. Moreover, this study will serve
      as a pilot mechanism to expand upon the findings in multiple ATN sites in a large-scale
      randomized control trial while measuring cardiometabolic outcomes. This pilot investigation
      has the potential to change standard of care within clinical practice that can be widely
      disseminated.

      Aim 1: To refine the HH4L manual to meet the needs of youth/adolescents and young adults (IQ
      > 70) with ASD on SGAs by adding Cognitive Behavioral Therapy (CBT) techniques for managing
      behaviors related to eating and physical activity to an empirically-validated pediatric
      obesity manual and incorporating developmentally appropriate modifications for individuals
      with ASD with an emphasis on family-based changes.

      Hypothesis 1.1: The CBT intervention will be feasible to deliver to adolescents and young
      adults with ASD and their family members.

      Hypothesis 1.2: Participants will attend treatment regularly with low attrition (≤ 20%) and
      high attendance (>80%).

      Aim 2: To test the efficacy of a psychiatrically-embedded weight management program for youth
      with ASD on SGAs. At the end of the 6-month program, youth receiving the weight management
      program (HH4L) will show improvements in:

      Hypothesis 2.1: Maintained or decreased weight on BMI z-score (Primary Outcome)

      Hypothesis 2.2: Ameliorated insulin resistance assessed by homeostatic model of assessment
      (HOMA-IR)(Secondary Outcome)

      Hypothesis 2.3: Decreased systemic inflammation evaluated by circulating high sensitivity
      C-reactive protein (hs-CRP)

      Exploratory Aim 3: To obtain a better understanding of how to support the effective
      implementation of HH4L into ATN sites.

      Hypothesis 3.1. Identify organizational, clinician, and patient factors associated with
      effective implementation.

      The main aim of this study is to adapt the Healthy Habits for Life manual to meet the needs
      of high-functioning adolescents and young adults with ASD who gain >7% of initial body weight
      while taking a SGA (or >5% if overweight/obese). HH4L is a CBT, MI, and family-based weight
      management intervention. However, proposed changes may include emphasizing the effects of
      SGAs on appetite, adapting cognitive foci to behavioral, emphasizing the role of family in
      stimulus control, and focusing on sneak eating.

      HH4L-ASD will involve eleven 45-minutes sessions over a 6-month period. Dependent measures
      will include physiological outcomes (e.g., Body Mass Index; BMI) and emotional/behavioral
      outcomes (e.g., Aberrant Behavior Checklist) collected at baseline and monthly there-after.
      While outcome data will inform next steps, the main aim of this pilot is to create a manual
      that can be implemented at all ATN sites.

      Study Flow: Families will be informed of the study by staff at the Pitt ATN. Interested
      families will undergo either a telephone or face-to-face screen, at which time they will be
      provided with additional information regarding study aims and expectations. At a subsequent
      in-person screen/baseline assessment, the child/family will have all questions answered and
      will sign an informed assent and consent. All participants will receive treatment. There are
      4 weekly sessions, 4 bi-weekly sessions, and 3 monthly booster sessions over a 6 month
      period. Given that some families come from far away and there are often barriers that impact
      patient attendance, 25% of all sessions will be permitted to be via phone or text sessions.
      These are options in line with prior investigations by PI Rofey. These telehealth standards
      are similar to the research group's prior work validating the effectiveness of HH4L.
      Participants will work one-on-one with a practitioner who has been delivering HH4L for over a
      decade. Retention rates are expected to be commensurate with similar studies (~ 90%).

      Data Management. The Principal investigators (PIs) will oversee all aspects of data
      management. With the consultation of the Massachusetts General Hospital Data Coordinating
      Center (DCC), the PIs and coordinator will develop an operations manual to standardize all
      procedures and staff training. All study participants will be assigned unique study
      identifiers that will appear on all data collection instruments, tapes, documents, and files
      used in the statistical analysis and manuscript preparation. The DCC also has specific data
      quality measures that will be implemented.

      Statistical Analyses Data will be summarized using sample means or proportions along with 95%
      confidence intervals within each study arm.

      Attrition and Missing Data. Every effort will be made to minimize the amount of attrition and
      missing data. The current research group has a history of successful retention of subjects in
      clinical research protocols. Participants are able to conveniently schedule research visits
      to correspond with regularly scheduled clinical appointments. Retention rates in 2 similar
      random control trials range from 80-90%. Follow-up assessments will be attempted even if a
      participant has dropped out of the training program. The investigators will also offer
      shortened assessments to convert initial refusals.

      Sample size. The sample size (25 participants) is based on feasibility considerations for the
      recruitment period. With 25 participants enrolled, the exact 95% confidence interval on a
      completion rate of 80% is 59.30%-93.17%. Assuming 80% have a 6-month BMI measurement, and 80%
      are lower than at baseline, the exact 95% confidence
    

Intervention name(s): Healthy Habits for Life
Intervention type(s): Behavioral
Intervention description(s): Healthy Habits for Life: 11-session, 6 month, one-on-one, dietician-lead weight management manualized treatment.
Intervention model: Single Group Assignment
Intervention model description: An 11 session, 6 month healthy lifestyle program comprised of 30 to 45 minute sessions run by a dietician.
Session 1 Getting Started/ anthropometric measures (weight, height, blood pressure and waist circumference)
Session 2 Healthy Eating Habits/ anthropometric measures
Session 3 Healthy Snacking Habits/anthropometric measures
Session 4 Healthy Portions & Servings Habits/ anthropometric measures
(BI-WEEKLY MEETINGS)
Session 5 Healthy Shopping Habits/ anthropometric measures
Session 6 Healthy Cooking & Mealtime Habits/ anthropometric measures .
Session 7 Healthy Dining Out Habits/ anthropometric measures
Session 8 Healthy Physical Activity Habits/ anthropometric measures
(MONTHLY MEETINGS)
Session 9 Healthy Eating Behavior Habits/ anthropometric measures
Session 10 Healthy Problem Solving Habits/anthropometric measures
Session 11 Maintaining a Healthy Lifestyle/ anthropometric measures
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Second Generation Antipsychotics; Weight Management