Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338806
Status:
COMPLETED
Last Update Posted:
2017-08-15
First Post:
2006-06-16
Brief Title:
Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Prevention for Symptomatic Offspring of Bipolar Parents
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will develop strategies for early detection and prevention of mood disorders and associated impairment in adolescent children of parents with bipolar disorder
Detailed Description:
Bipolar Disorder BD is a serious medical illness that causes drastic shifts in a persons mood energy and ability to function BD symptoms alternate from increased energy restlessness and overly good mood to a lasting sad anxious or empty mood and feelings of hopelessness or pessimism Research suggests that children of parents with BD are at risk for developing mood disorders because of predisposing genetic factors and stressful life events many of which may be related to their parents unstable clinical state Adolescent children of parents with BD must deal simultaneously with the difficult task of negotiating their own developmental transitions as well as living with a parent with BD It may be possible to detect symptoms of BD or other mood disorders early in adolescence and prevent the disorder from further interfering with someones life This study will develop and refine strategies for early detection and primary prevention of mood disorders and associated impairment in adolescent children of parents with BD
Participants in this single-blind study will be randomly assigned to receive either interpersonal psychotherapy with adolescents IPT-PA or a control intervention educational clinical monitoring ECM for 12 weeks Participants assigned to IPT-PA will attend twelve sessions The first four sessions will last 90 minutes each and will include both family psychoeducation and individual psychotherapy with the adolescent The remaining sessions will be 45 minutes each and will include only individual psychotherapy with the adolescent Participants assigned to ECM will each be assigned to a therapist During the initial two sessions which will take place over 2 consecutive weeks the therapist will focus on mood disorder psychoeducation and participants will receive related written educational material Participants will then meet with their therapists monthly for 30-minute sessions Symptoms and functioning will be assessed but no assistance on building interpersonal skills will be provided A participant may request a second session each month but if more than two monthly sessions are required the participant will be referred for therapy Mood episodes and symptoms symptom severity and functioning will be assessed for all participants at Weeks 6 and 12 and Months 6 12 and 18 post-treatment
Participants in this single-blind study will be randomly assigned to receive either interpersonal psychotherapy with adolescents IPT-PA or a control intervention educational clinical monitoring ECM for 12 weeks Participants assigned to IPT-PA will attend twelve sessions The first four sessions will last 90 minutes each and will include both family psychoeducation and individual psychotherapy with the adolescent The remaining sessions will be 45 minutes each and will include only individual psychotherapy with the adolescent Participants assigned to ECM will each be assigned to a therapist During the initial two sessions which will take place over 2 consecutive weeks the therapist will focus on mood disorder psychoeducation and participants will receive related written educational material Participants will then meet with their therapists monthly for 30-minute sessions Symptoms and functioning will be assessed but no assistance on building interpersonal skills will be provided A participant may request a second session each month but if more than two monthly sessions are required the participant will be referred for therapy Mood episodes and symptoms symptom severity and functioning will be assessed for all participants at Weeks 6 and 12 and Months 6 12 and 18 post-treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23MH071530 | NIH | None | httpsreporternihgovquickSearchK23MH071530 |