DepressionNCT01778478
A Pilot Study to Extend the K-SADS-PL to Adolescents and Young Adults
An observational study of Depression and Anxiety Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: An interview called the Schedule for Affective Disorders and Schizophrenia for School Age Children Present and Lifetime version (K-SADS-PL) is used to identify mental health problems among children and younger teens. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression, Anxiety Disorder, Cancer
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2013to 23 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- a. Description of proband patients and healthy volunteers: these adult participants between the ages of 18-25 will be invited to undergo a psychiatric diagnostic interview using the K-SADS PL. Current or past history of mental health problems or treatment is allowed.
- Proband patient/healthy volunteer inclusion criteria
- Age 18-25 years, males and females
- English speaking
- Participant has contact (face-to-face, phone or electronic) with at least one of his/her parents at least once per week
- Enrolled in an NIH CC study (probands) or in good general health (healthy volunteers)
- Proband patient/healthy volunteer exclusion criteria
- Unable to provide informed consent
- Known severe intellectual disability such as a history of mental retardation, pervasive developmental disorder or inability to complete an 8th grade education.
- Initial cancer diagnosis within the past 3 months.
- Current unstable medical condition as evidenced by Karnofsky score below 50 (for cancer patients)
- Refusal to be video or audio recorded
- Cancer that involves the brain either as primary site of cancer or as a result of metastatic disease.
- Description of parent participants: If there is more than one parent who is eligible, the parent who knows the participant best will be chosen. For this study, we define parent as a primary caregiver during the participant s early life who directly observed the child s development and is still alive to be interviewed. This could allow for informants who are adoptive parents or other close relatives who raised the child.
- Parent participant inclusion criteria
- English speaking
- Parent of a patient proband or healthy volunteer enrolled in the study
- Parent has contact (face-to-face, phone or electronic) with his/her child at least once per week
- Parent participant exclusion criteria
- Unable to provide informed consent
- Known severe intellectual disability such as a history of mental retardation, pervasive developmental disorder or inability to complete an 8th grade education.
- Refusal to be video or audio recorded
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Pilot Study to Extend the K-SADS-PL to Adolescents and Young Adults
Background:
- An interview called the Schedule for Affective Disorders and Schizophrenia for School Age Children Present and Lifetime version (K-SADS-PL) is used to identify mental health problems among children and younger teens. Both the child and a parent are asked questions about the child s behaviors and symptoms that might indicate such problems. Researchers want to see if the K-SADS-PL can help identify mental health problems in young adults (ages 18 to 25). Two groups of young adults, including healthy volunteers and people with cancer, and their parents will participate in this study.
Read more
Objectives:
- To see if the K-SADS-PL interview used for children and teens can also be used for young adults.
- To see whether information provided by parents will affect the rate of mental health problems found.
Eligibility:
- Individuals aged 18-25 years who have cancer and are participating in research studies at the National Institutes of Health.
- Healthy volunteers aged 18-25 years.
- A parent of a young adult who is participating in this study.
Design:
- This study requires one study visit that includes an interview and self-report questionnaires. It will take about 1 to 3 hours. A follow-up phone call or visit will also be required.
- Young adult participants will be given the K-SADS-PL interview and four questionnaires that ask about mood, anxiety, distress, parental contact, and development during childhood. The K-SADS-PL interview will be video recorded or audio recorded.
- Parents will also be given the K-SADS-PL interview. This interview can be done in person or by phone, and will also be recorded.
- No treatment will be provided as part of this study.
Read the detailed description
Objective:
The goal of this pilot project is to describe the feasibility of using the Schedule for Affective Disorders and Schizophreni\a for School Age Children Present and Lifetime Version (K-SADS-PL) to screen and evaluate older adolescents and young adults (ages 18-25) for mood and anxiety disorders. An additional aim is to describe the contribution of the parent interview portion of the instrument for this age group. Two groups of 18-25 year old participants will be enrolled: healthy volunteers and patients with cancer. The information gained in this pilot study will inform the design of future intervention studies that target mood and anxiety disorders among pediatric oncology patients.
Primary aim:
Aim 1: Feasibility - Describe the feasibility of using the K-SADS-PL interview to screen and evaluate for mood and anxiety disorders among two groups of 18 25 year olds (healthy volunteers and patients with cancer) and their parents.
Hypothesis 1: The K-SADS-PL interview is feasible to use in the two groups of 18 25 year olds; the feasibility of completing the parent portion of the K-SADS-PL will be better among parents of cancer participants compared to parents of healthy volunteers.
Secondary aim:
Aim 2: K-SADS-PL outcomes - Compare and contrast K-SADS-PL findings based on responses provided by participants versus summary ratings that take into account both parent and child responses.
Hypothesis 2: Summary ratings of K-SADS-PL screening and diagnostic questions will yield more positive screening findings (subthreshold or threshold) compared to participant ratings alone.
Study population
This pilot study will include a convenience sample of young adults, aged 18-25, from two groups healthy volunteers and individuals who are participants in oncology protocols at the NIH Clinical Center (inpatient or outpatient) and who agree to participate. Participants may be from any institute, but must have a parent who will agree to be interviewed.
Design
This is a pilot study to describe the feasibility of extending the K-SADS-PL diagnostic interview to screen and evaluate young adults 18-25 years of age for psychiatric disorders. Informed consent will be obtained from the participant and his/her parent. The interview will be administered by a interviewer trained to administer the K-SADS-PL instrument. The same interviewer will administer the K-SADS-PLL to both the participant and the parent. The participant will be interviewed first, and the parent second. If there is more than one parent who is eligible, the parent who knows the participant best will be chosen. All interviews will be recorded. A subset of interview recordings will be randomly rated by a gold standard expert rater to determine inter-rater kappa coefficients for screening and diagnostic questions about mood and anxiety disorders.
Availability of parents to complete the K-SADS-PL interview will be optimized by allowing either face-to-face or phone interviews. If a parent interview reveals clinically significant information that the participant did not report, the interviewer will re-contact the participant to complete the necessary diagnostic module. Summary screening and diagnostic ratings will be determined by the interviewer, taking into account both participant and parent responses as per the K-SADS-PL design.
We will also ask participants to complete several short questionnaires:1) Hospital Anxiety and Depression Scale (HADS); 2) Parent-child frequency of contact; 3) Distress Thermometer; 4) Course of Life questionnaire.
- Conditions
- Depression, Anxiety Disorder, Cancer
- Keywords
- Anxiety, Depression, Adolescents and Adults, Cancer Diagnosis
- Medical subject headings
- Depression, Anxiety Disorders, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility defined in the 18-25 year old cancer patient group as a completion rate of greater than or equal to 60 percent among those approached to enter the study.
Measured: 2 years
Feasibility in parents is greater than or equal to 80 percent completion rate of the parent portion of the K-SADS-PL interview.
Measured: 2 years
Secondary outcomes (2)
Frequency of positive (threshold or subthreshold) KSADS-PL summary ratings in both groups of participants.
Measured: 2 years
2x2 tables and kappa statistics that describe agreement between participant responses and summary ratings.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study start26 Jan 2013
- Primary completion25 Aug 2016
- Study completion23 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joyce Y Chung, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778478
- Sponsor's protocol ID
- 130019
- Other IDs
- 13-M-0019
- Status last verified
- 23 May 2018
- First submitted
- 26 Jan 2013
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Ambrosini PJ. Historical development and present status of the schedule for affective disorders and schizophrenia for school-age children (K-SADS). J Am Acad Child Adolesc Psychiatry. 2000 Jan;39(1):49-58. doi: 10.1097/00004583-200001000-00016.
PubMed 10638067Birmaher B, Ehmann M, Axelson DA, Goldstein BI, Monk K, Kalas C, Kupfer D, Gill MK, Leibenluft E, Bridge J, Guyer A, Egger HL, Brent DA. Schedule for affective disorders and schizophrenia for school-age children (K-SADS-PL) for the assessment of preschool children--a preliminary psychometric study. J Psychiatr Res. 2009 Apr;43(7):680-6. doi: 10.1016/j.jpsychires.2008.10.003. Epub 2008 Nov 8.
PubMed 19000625Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
PubMed 11832252
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Extend the K-SADS-PL to Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT01778478
- Acronym / sponsor ID
- 130019
- Conditions
- Depression, Anxiety Disorder, Cancer
- Keywords
- Anxiety, Depression, Adolescents and Adults, Cancer Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 26 Jan 2013
- Primary completion
- 25 Aug 2016 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- An interview called the Schedule for Affective Disorders and Schizophrenia for School Age Children Present and Lifetime version (K-SADS-PL) is used to identify mental health problems among children and younger teens. Both the child and a parent are asked questions about the child s behaviors and symptoms that might indicate such problems. Researchers want to see if the K-SADS-PL can help identify mental health problems in young adults (ages 18 to 25). Two groups of young adults, including healthy volunteers and people with cancer, and their parents will participate in this study.
Objectives:
- To see if the K-SADS-PL interview used for children and teens can also be used for young adults.
- To see whether information provided by parents will affect the rate of mental health problems found.
Eligibility:
- Individuals aged 18-25 years who have cancer and are participating in research studies at the National Institutes of Health.
- Healthy volunteers aged 18-25 years.
- A parent of a young adult who is participating in this study.
Design:
- This study requires one study visit that includes an interview and self-report questionnaires. It will take about 1 to 3 hours. A follow-up phone call or visit will also be required.
- Young adult participants will be given the K-SADS-PL interview and four questionnaires that ask about mood, anxiety, distress, parental contact, and development during childhood. The K-SADS-PL interview will be video recorded or audio recorded.
- Parents will also be given the K-SADS-PL interview. This interview can be done in person or by phone, and will also be recorded.
- No treatment will be provided as part of this study.
Detailed description
Objective:
The goal of this pilot project is to describe the feasibility of using the Schedule for Affective Disorders and Schizophreni\a for School Age Children Present and Lifetime Version (K-SADS-PL) to screen and evaluate older adolescents and young adults (ages 18-25) for mood and anxiety disorders. An additional aim is to describe the contribution of the parent interview portion of the instrument for this age group. Two groups of 18-25 year old participants will be enrolled: healthy volunteers and patients with cancer. The information gained in this pilot study will inform the design of future intervention studies that target mood and anxiety disorders among pediatric oncology patients.
Primary aim:
Aim 1: Feasibility - Describe the feasibility of using the K-SADS-PL interview to screen and evaluate for mood and anxiety disorders among two groups of 18 25 year olds (healthy volunteers and patients with cancer) and their parents.
Hypothesis 1: The K-SADS-PL interview is feasible to use in the two groups of 18 25 year olds; the feasibility of completing the parent portion of the K-SADS-PL will be better among parents of cancer participants compared to parents of healthy volunteers.
Secondary aim:
Aim 2: K-SADS-PL outcomes - Compare and contrast K-SADS-PL findings based on responses provided by participants versus summary ratings that take into account both parent and child responses.
Hypothesis 2: Summary ratings of K-SADS-PL screening and diagnostic questions will yield more positive screening findings (subthreshold or threshold) compared to participant ratings alone.
Study population
This pilot study will include a convenience sample of young adults, aged 18-25, from two groups healthy volunteers and individuals who are participants in oncology protocols at the NIH Clinical Center (inpatient or outpatient) and who agree to participate. Participants may be from any institute, but must have a parent who will agree to be interviewed.
Design
This is a pilot study to describe the feasibility of extending the K-SADS-PL diagnostic interview to screen and evaluate young adults 18-25 years of age for psychiatric disorders. Informed consent will be obtained from the participant and his/her parent. The interview will be administered by a interviewer trained to administer the K-SADS-PL instrument. The same interviewer will administer the K-SADS-PLL to both the participant and the parent. The participant will be interviewed first, and the parent second. If there is more than one parent who is eligible, the parent who knows the participant best will be chosen. All interviews will be recorded. A subset of interview recordings will be randomly rated by a gold standard expert rater to determine inter-rater kappa coefficients for screening and diagnostic questions about mood and anxiety disorders.
Availability of parents to complete the K-SADS-PL interview will be optimized by allowing either face-to-face or phone interviews. If a parent interview reveals clinically significant information that the participant did not report, the interviewer will re-contact the participant to complete the necessary diagnostic module. Summary screening and diagnostic ratings will be determined by the interviewer, taking into account both participant and parent responses as per the K-SADS-PL design.
We will also ask participants to complete several short questionnaires:1) Hospital Anxiety and Depression Scale (HADS); 2) Parent-child frequency of contact; 3) Distress Thermometer; 4) Course of Life questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility defined in the 18-25 year old cancer patient group as a completion rate of greater than or equal to 60 percent among those approached to enter the study.
Time frame: 2 years
Feasibility in parents is greater than or equal to 80 percent completion rate of the parent portion of the K-SADS-PL interview.
Time frame: 2 years
2 secondary outcomes
Frequency of positive (threshold or subthreshold) KSADS-PL summary ratings in both groups of participants.
Time frame: 2 years
2x2 tables and kappa statistics that describe agreement between participant responses and summary ratings.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 10638067Ambrosini PJ. Historical development and present status of the schedule for affective disorders and schizophrenia for school-age children (K-SADS). J Am Acad Child Adolesc Psychiatry. 2000 Jan;39(1):49-58. doi: 10.1097/00004583-200001000-00016.
- Background: PubMed 19000625Birmaher B, Ehmann M, Axelson DA, Goldstein BI, Monk K, Kalas C, Kupfer D, Gill MK, Leibenluft E, Bridge J, Guyer A, Egger HL, Brent DA. Schedule for affective disorders and schizophrenia for school-age children (K-SADS-PL) for the assessment of preschool children--a preliminary psychometric study. J Psychiatr Res. 2009 Apr;43(7):680-6. doi: 10.1016/j.jpsychires.2008.10.003. Epub 2008 Nov 8.
- Background: PubMed 11832252Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Y Chung, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility defined in the 18-25 year old cancer patient group as a completion rate of greater than or equal to 60 percent among those approached to enter the study. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01778478, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019; AzTrials last refreshed its copy on 5 Nov 2026.