Bipolar DisorderNCT00001170
Study of the Psychological Development of Children of Parents With and Without Affective Disorders
An observational study of Bipolar Disorder and Involutional Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This research study is the continuation of a study started more than 20 years ago. The study was designed to explore the effect that depressed parents have on their children and to better understand the factors that contribute to depression development and maintenance. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Involutional Depression, Mood Disorder
- How many people
- 1,045 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1979to Feb 2005
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Patients will be drawn from an ongoing longitudinal study begun in 1979 of offspring of parents with affective illness (unipolar and bipolar) and children of normal control parents.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: Affective Disorders and Affective Development: A Study of Child Rearing and Child Development in Normal Families and Families With Affective Disorders
This research study is the continuation of a study started more than 20 years ago. The study was designed to explore the effect that depressed parents have on their children and to better understand the factors that contribute to depression development and maintenance.
The study will continue to investigate if children have certain characteristics in early and middle childhood that predict the later development of psychological disorders.
In addition, the study will continue looking at the processes responsible for the development of children of parents with and without affective (mood) disorders.
Read the detailed description
The psychological development of offspring of parents with and without affective disorder is assessed from early childhood to young adulthood. Parents with a diagnosis of major depression or bipolar illness and well parents and their children are studied (SADS-L, RDC, and SCID, DSM-III). A sibling pair is studied in each family. Parent-child interaction is investigated through direct observation of behavior in naturalistic and controlled settings. Family history information is obtained through parent interviews. Behavioral observations, standard tests, physical examinations, and psychiatric interviews, and MRI procedures provide multiple assessments of the offspring. The study has been completed through preadolescence, adolescence, and late adolescence. Follow-up in young adulthood continues.
- Conditions
- Bipolar Disorder, Involutional Depression, Mood Disorder
- Keywords
- Parental Psychopathology, Child Rearing, Depression, Bipolar Affective Disorders, Manic-Depression, Social-Emotional Development, Cognitive Development, Child Psychopathology, Affective Disorder, Children at Risk
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Mood Disorders, Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startOct 1979
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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
- Enrolment
- 1,045 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001170
- Sponsor's protocol ID
- 790123
- Other IDs
- 79-M-0123
- Status last verified
- Feb 2005
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Achenbach TM, Edelbrock CS. The Child Behavior Profile: II. Boys aged 12-16 and girls aged 6-11 and 12-16. J Consult Clin Psychol. 1979 Apr;47(2):223-33. doi: 10.1037//0022-006x.47.2.223. No abstract available.
PubMed 469068Beardslee WR, Bemporad J, Keller MB, Klerman GL. Children of parents with major affective disorder: a review. Am J Psychiatry. 1983 Jul;140(7):825-32. doi: 10.1176/ajp.140.7.825.
PubMed 6344660Billings AG, Moos RH. Comparisons of children of depressed and nondepressed parents: a social-environmental perspective. J Abnorm Child Psychol. 1983 Dec;11(4):463-85. doi: 10.1007/BF00917076.
PubMed 6655148Labella MH, Ruiz SK, Harris SJ, Klimes-Dougan B. Emotion socialization in mothers with mood disorders: Affective modeling and recollected responses to childhood emotion. Dev Psychopathol. 2021 Oct;33(4):1156-1169. doi: 10.1017/S0954579420000395.
PubMed 32672147Klimes-Dougan B, Long JD, Lee CY, Ronsaville DS, Gold PW, Martinez PE. Continuity and cascade in offspring of bipolar parents: a longitudinal study of externalizing, internalizing, and thought problems. Dev Psychopathol. 2010 Nov;22(4):849-66. doi: 10.1017/S0954579410000507.
PubMed 20883586
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective Disorders and Affective Development: A Study of Child Rearing and Child Development in Normal Families and Families With Affective Disorders
- ClinicalTrials.gov ID
- NCT00001170
- Acronym / sponsor ID
- 790123
- Conditions
- Bipolar Disorder, Involutional Depression, Mood Disorder
- Keywords
- Parental Psychopathology, Child Rearing, Depression, Bipolar Affective Disorders, Manic-Depression, Social-Emotional Development, Cognitive Development, Child Psychopathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,045 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Oct 1979
- Study completion
- Feb 2005
- First posted
- 4 Nov 1999 (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.
This research study is the continuation of a study started more than 20 years ago. The study was designed to explore the effect that depressed parents have on their children and to better understand the factors that contribute to depression development and maintenance.
The study will continue to investigate if children have certain characteristics in early and middle childhood that predict the later development of psychological disorders.
In addition, the study will continue looking at the processes responsible for the development of children of parents with and without affective (mood) disorders.
Detailed description
The psychological development of offspring of parents with and without affective disorder is assessed from early childhood to young adulthood. Parents with a diagnosis of major depression or bipolar illness and well parents and their children are studied (SADS-L, RDC, and SCID, DSM-III). A sibling pair is studied in each family. Parent-child interaction is investigated through direct observation of behavior in naturalistic and controlled settings. Family history information is obtained through parent interviews. Behavioral observations, standard tests, physical examinations, and psychiatric interviews, and MRI procedures provide multiple assessments of the offspring. The study has been completed through preadolescence, adolescence, and late adolescence. Follow-up in young adulthood continues.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, 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
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 469068Achenbach TM, Edelbrock CS. The Child Behavior Profile: II. Boys aged 12-16 and girls aged 6-11 and 12-16. J Consult Clin Psychol. 1979 Apr;47(2):223-33. doi: 10.1037//0022-006x.47.2.223. No abstract available.
- Background: PubMed 6344660Beardslee WR, Bemporad J, Keller MB, Klerman GL. Children of parents with major affective disorder: a review. Am J Psychiatry. 1983 Jul;140(7):825-32. doi: 10.1176/ajp.140.7.825.
- Background: PubMed 6655148Billings AG, Moos RH. Comparisons of children of depressed and nondepressed parents: a social-environmental perspective. J Abnorm Child Psychol. 1983 Dec;11(4):463-85. doi: 10.1007/BF00917076.
- Derived from this study: PubMed 32672147Labella MH, Ruiz SK, Harris SJ, Klimes-Dougan B. Emotion socialization in mothers with mood disorders: Affective modeling and recollected responses to childhood emotion. Dev Psychopathol. 2021 Oct;33(4):1156-1169. doi: 10.1017/S0954579420000395.
- Derived from this study: PubMed 20883586Klimes-Dougan B, Long JD, Lee CY, Ronsaville DS, Gold PW, Martinez PE. Continuity and cascade in offspring of bipolar parents: a longitudinal study of externalizing, internalizing, and thought problems. Dev Psychopathol. 2010 Nov;22(4):849-66. doi: 10.1017/S0954579410000507.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bipolar Disorder and Involutional Depression, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001170, which also lists 5 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 4 Mar 2008.