Maximizing Biospecimen Collection for Childhood Disorders

Project Name:
Maximizing Biospecimen Collection for Childhood Disorders
Principal Investigator:
Lisa Croen, PhD
Principal Investigator Contact Information:
Principal Investigator institution:
Kaiser Permanente Northern California, Oakland, CA
Funding Period:
07/2015– 06/2018
Autism Spectrum Disorder (ASD) and Bipolar Disorder (BD) are the two most common severe mental disorders affecting children and adolescents.  Few evidence-based treatments exist for either condition.  Furthermore, response to treatment varies widely between individuals – and no evidence exists to match individual children with specific treatments.  Research to address these gaps – both to develop new treatments and to more effectively match individuals with treatments – will isolating on identifying biomarkers or endophenotypes that can accurately identify more homogeneous subgroups of patients and genetically related family members.  This next generation of research will require collecting biospecimens from large and representative samples of families affected by childhood mental disorders and linking those specimens to comprehensive and longitudinal health records. The main aim of this pilot is to identify the best ways to maximize biospecimen collection from children with mental health conditions.  We plan to meet this goal by leveraging and extending our work during the first cycle of MHRN funding on the feasibility of biospecimen collection from families of children with Autism Spectrum Disorder (ASD).  We will use a mixed methods approach to develop low-cost, tailored recruitment and consenting processes that specifically address concerns about participating in studies using biospecimens from children with mental health conditions and that are appropriate to large and diverse populations.  
Grant Number:
Participating Sites:                                       Kaiser Permanente Northern California, Oakland, CA (Lead Site)Kaiser Permanente Georgia, Atlanta, GAKaiser Permanente Northwest, Portland, OR
Lisa Croen, PhD
Ashli Owen-Smith, PhD
Frances Lynch, PhD
Major Goals: Specific Aim 1: Using data from a feasibility study of biospecimen collection conducted during the first cycle of MHRN funding and health system electronic medical record (EMR) data, we will examine the demographic and clinical characteristics of children and their families predicting successful recruitment of families to participate in biospecimen collection. Specific Aim 2: Explore knowledge, attitudes and beliefs about biobanking and perceived facilitators and barriers to biobank participation among parents of children with mental health conditions from diverse backgrounds using ethnographic/qualitative methods (interviews, focus groups). Specific Aim 3: a) Develop tailored methods for recruiting and consenting children/adolescents with mental health conditions and their families into a biospecimen bank for future research) Develop a strategy for pilot testing those methods across different pediatric mental health conditions.  Focus on low-cost methods appropriate for large and diverse populations
Description of study sample:
Fifteen families who participated in the MHRN1 study at each of the three study sites, for a total of 45 ASD interviews and 15 families who have a child with a bipolar disorder diagnosis at KPNC, for a grand total of 60 families.
Current Status:
Aim 1: Completed data analysis.Aim 2: Data analysis was completed. Manuscript has been drafted and is expected to be submitted for publication in the Fall of 2019.
Study Registration:15 ASD families have been recruited at KPGA15 ASD families have been recruited at KPNW30 families (15 ASD and 15 Bipolar) families have been recruited at KPNC.
Manuscript for Aim 2 to be submitted for publication in the Fall of 2019.
Lessons Learned:
In spite of the profound caregiver burden experienced by many parents of children with serious mental health-related issues, participants in the present study were eager to participate in research, in general, and in biospecimen research, in particular, as long as the research process involved trust, clarity, and flexibility. Researchers working with these populations need to make it easy for families to participate – even if that is less convenient and more costly for them – and should prioritize the sharing of knowledge gained by the research with participants at the end of the study.
What’s next? Working on new manuscripts.