This study is closed to enrollment.
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PURPOSE OF THE STUDY
The aim of this proposal, “Outcomes of Preschool Mental Health Problems,” is to examine the predictive validity of preschool anxiety and depressive symptoms, syndromes, and disorders by following a cohort of preschoolers with two waves of assessment. We propose to build upon a study of 307 children aged 2 to 5 involved in a successful test-retest study of a psychiatric diagnostic interview for parents of preschoolers (the Preschool Age Psychiatric Assessment – PAPA). In the original study, we screened 1,073 parents of preschool children attending a general pediatric clinic with the parent-report Child Behavior Checklist 11/2-5 (CBCL). Parents of children screening at or above the 30th percentile (N=193) and a random selection of the rest (N=114) were administered the PAPA on two occasions separated by a week. The sample was stratified by age (2-5), gender, and race (African-American versus non-African-American). Data was weighted back to obtain prevalence rates of psychiatric symptoms and disorders in the screened population. In this follow-up study, predictive validity will be examined through the (1) temporal stability of psychiatric symptoms, syndromes, and disorders and (2) prediction of preschool symptoms to later psychiatric symptoms, disorders, and impairment and (3) association of early childhood anxiety and depressive symptoms and disorders with psychosocial impairment, neurocognitive deficits, particularly language problems, and risk factors including adverse life events, problems in the parent-child relationship, parental stress, and parental psychopathology. In the absence of any gold-standard for the identification of preschool psychiatric syndromes we adopt a construct-validation approach based on reasonable expectations for (1) stability over time of (a) syndrome scale scores (e.g., count of depressive symptoms) and (b) categorical syndromes (e.g., major depressive disorder) (homotypic continuity); (2) continuity of syndrome scale score and categorical syndrome problems even when those problems change in form over time (e.g., from depressive to conduct symptoms – heterotypic continuity).
BACKGROUND & SIGNIFICANCE
Little is known about preschool anxiety disorders and depression. The long term goal of our research program is to contribute to an empirically grounded picture of preschool psychiatric symptoms and disorders that can be translated into effective diagnostic, screening and treatment approaches to help young children and their families.
DESIGN & PROCEDURES
A sample of 307 parents of children ages 2-5 year old were recruited for a test–retest study of the Preschool Age Psychiatric Assessment (PAPA) (“Assessing Preschool Comorbidity: A Test-Retest Study;” PI: Adrian Angold MRCPsych; Co-PI: Helen Link Egger MD; NIMH grant #1RO-MH-63670-01; IRB #2686-01-4ER) that was completed May 2003. Here we propose to add two waves of follow-up to this study. The first wave will be a three-year follow-up, while wave 2 will occur an additional 2 years later. Across these two waves, the children’s ages will range from 5 to 12 years old. We will use multi-modal, multi-informant assessments of psychiatric symptoms and disorders, as well as measures of developmental status, parent-child interactions, and risk factors known to be associated with psychiatric symptoms in older children. Inclusion criteria are: children aged 5 to 11 years old whose parent participated in the test-retest study of the PAPA. Exclusion criteria are: IQ less than 70, a diagnosis of autism, or a parent who does not have proficient English to complete the interviews.
The protocol for the 2 year follow-up (wave 2) consists of 1 session lasting 2 to 3 hours. During the assessment, the parent version of the CAPA will be administered to the parent in either the home or our office, based on the parent’s preference. The child version of the CAPA will be administered to the child. If the parent and child did not participate in the 3 year follow-up (wave 1) the child will complete an additional language and reasoning assessment.
Table 1 below details the assessments to be used in wave 2.
|Table 1. Assessment schedule by age of child|
|Setting, Informant||Follow-up 1 (age 5-8)||Follow-up 2 (age 8 or older)|
Parent (1½-2 hours)
Parent (2½-3 hours)
Child (1½-2 hours)
Child (1½-2 hours)
CAPA-C (8 or older)
|CAPA-P (8 or older)
CAIA (8 or older)
Report on child MFQ
EATQ (9 or older)
PSI, CTSPC, BAI, CIDI
CAPA-C (8 or older)
If subject did not complete follow-up 1, child will complete DAS
Parent and child (20 minutes)
Parent (1¼-1¾ hours)
Child (1 ½ – 2 hours)
There will be no laboratory assessment.
BDI, BAI, CIDI
CTS2, CTSPC, CHADIS
No laboratory assessment for
Childcare provider (½ hour)
Teacher (½ hour)
TRF, SSRS(6 or older)
|Abbreviations: PAPA=Preschool-Age Psychiatric Assessment; CAPA=Child and Adolescent Psychiatric Assessment; CAPA-P=CAPA for parent; CAPA-C=CAPA for child; CAIA=Child and Adolescent Impact Assessment; DB-DOS=Diagnostic Behavior-Diagnostic Observation Scale (parent-child module P-COS); BDI=Beck Depression Inventory; BAI=Beck Anxiety Inventory; CIDI= Composite International Diagnostic Interview; PSI=Parenting Stress Index; CBQ=Children’s Behavior Questionnaire; EATQ=Early Adolescent Temperament Questionnaire; CTS2=Conflict Tactics Scale (mother-partner); CTSPC=Conflict Tactics Scale (parent-child); Vineland=Vineland Adaptive Behavior Scales; BPI=Berkeley Puppet Interview; MSSB=MacArthur Story-Stem Battery; DAS=Differential Ability Scales; BSRA=Bracken School Readiness Assessment; TRF=Teacher Report Form; C-TRF=Caregiver TRF; SSRS=Social Skills Rating System. CHADIS = Child Health and Development Interactive System.|
We will also collect teacher data on subjects. Additionally, we will conduct a thirteen question survey, called the Short Mood and Feeling Questionnaire (sMFQ) over the telephone with parents once every three months.
We will recruit families who participated in the test-retest study of the PAPA. We will first send an IRB-approved letter telling the parent that we will be calling to talk about participating in this follow-up study. We will then call the parent using an IRB-approved telephone script. If the parent is willing to participate, we will schedule an appointment. Informed consent will be obtained from the parent/guardian for administering the assessment for contacting the child’s teacher/babysitter and for recording the assessments. Consent will be obtained from the teacher/caregiver to provide information. Verbal assent will be obtained from the child if possible.
Costs to participants are their time and effort. There are no expenses associated with this study. The risks of the study are those associated with discussing personal issues with a trained interviewer: possible embarrassment and distress. Interviewers are trained to ameliorate these effects and procedures are in place for referring seriously distressed subjects for psychiatric evaluation and treatment (see below). Compensation for subjects is described below. Direct benefits to the parents are the compensation provided (see below) and the opportunity to help in a study that will greatly increase public knowledge about psychopathology in very young children and the need for treatment and prevention of preschool mental illness.
Children or parents are occasionally identified who appear to be at serious risk of suicidal or homicidal actions, or who are subject to physical, sexual, or emotional abuse or neglect. When an interviewer believes that such a possibility exists, s/he at once consults with the project coordinator. He will determine if the case meets the criteria laid down in the guidelines specified by the study’s clinical faculty (Angold and Egger) and will consult with one of them. Drs. Angold and Egger are both child psychiatrists. If it is determined by the clinician that intervention is mandated, the interviewer will call and explain to the parent the reasons why it was deemed necessary to obtain a clinical consultation, and will offer referral to the appropriate agency or, in the case of suspected abuse, file the necessary Child Protective Services Law report. All parents will be given information about the mental health services available at Duke Primary Care pediatric clinic and at the Child Guidance Clinic at Duke University Medical Center. Written reports will be made every time an emergency plan is implemented.
SUBJECT IDENTIFICATION, RECRUITMENT, AND COMPENSATION
Please see the Design and Procedures section for details about the subject identification and recruitment. The subjects will be compensated for participating in this study. After completing Follow-up #2 (wave 2), the parent will be paid $65. The child will be paid $25.The parental reimbursement is intended to pay for travel, parking, and childcare for siblings, and to reimburse participants for their time and effort.
We will offer teachers the option of filling out the questionnaires by hand then returning them by mail or fill out the questionnaires at a secure website. The package sent to the teacher will contain the consent forms from the parent for the teacher to fill out the questionnaire, the questionnaires (Teacher’s Report Form and Social Skills Rating System), and the secure website URL and a password to access the form. If the teacher decides to fill out the questionnaires by hand, they will sign the consent form and return the consent and questionnaires in the provided self-addressed, stamped envelope. If the teacher opts to fill out the questionnaires online, the teacher will electronically consent. The teacher will only be able to access that particular subject’s questionnaires. The password will expire upon the completion of the questionnaire or 30 days after the teacher accesses the questionnaires (if the teacher does not complete it on their first attempt). Teachers who fill out the measures will be given a $5.00 gift certificate. See Data Storage and Confidentiality Section below.
We will not include parents who are not competent to provide consent. If the child objects to participating in any part of the protocol or becomes distressed, we will stop the assessment.
COSTS TO THE SUBJECT
Subjects will incur no costs as result of participating in this study.
DATA ANALYSIS & MONITORING
Statistical methods for data analysis will include exploratory data analysis, factor analysis, and logistic regression for testing hypotheses and model building. Our statistical expert Alaattin Erkanli, PhD. will be closely involved in all phases of the data analyses. No data monitoring committee will be used. Data on eye position will be analyzed using both multivariate and spatial statistics
DATA STORAGE & CONFIDENTIALITY
Data will be collected in the form of written interview schedules, tape recordings of this interview, and video recordings of the BPI and the DB-DOS. Ensuring the integrity and confidentiality of the data is an essential part of safeguarding the rights of subjects. The Center for Developmental Epidemiology, from whose offices the study will be conducted, has instituted a series of checks at several levels of data handling, to maintain its quality and confidentiality.  Interviewers, many of whom have many years’ experience in survey work; will be given extra training in the importance of confidentiality in psychiatric interviewing. Like all study personnel, they will promise in writing to maintain that confidentiality.  After data are entered, the protocol (in both its physical (paper and pencil) and electronic (entered data) forms) will be identified by number only. From this point it will not be possible to trace it back to an individual except by linking with a separate computer file that links the identification number with the individual’s identity. This file is password protected, and kept in a special computer volume to which only our (a) network administrator and (b) senior data manager have access rights.  Protocols and tapes will be kept in locked file cabinets in a locked storage room in a research facility that is locked at night.  Written reports and papers will not identify subjects or make identification possible, without the written consent of the person concerned. Our data storage plans have been developed to be fully compliant with HIPPA safeguards.
The web application that supports the teacher questionnaire uses strong encryption technology for all data transfers, secure passwords for user accounts and server infrastructure that is maintained to comply with Duke Health Enterprise Computer Security Standards. These Standards have been designed by the Duke Information Security Office (ISO) to ensure enterprise-wide compliance with applicable Federal and North Carolina law, such as HIPAA and the NC Identity Theft Protection Act. The ISO verifies compliance of covered systems by performing internal audits.