Early Assessment and Intervention for Adolescents at Risk for Bipolar Disorder
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 12 - 18 |
| Updated: | 7/14/2018 |
| Start Date: | April 1, 2011 |
| End Date: | February 28, 2015 |
Bipolar disorder is a severe and chronic illness associated with significant occupational and
social impairment, enormous public health costs, and high rates of suicide. The single most
potent risk factor for the development of bipolar disorder is a first-degree family member
with the illness; indeed, offspring of parents with bipolar disorder are a particularly
high-risk group who typically display early onset and severe course of illness. Thus, early
assessment and intervention for the children of parents with bipolar disorder focused on
specific, measurable, and modifiable risk factors has the potential to prevent or ameliorate
the progression of bipolar disorder in those at highest risk.
social impairment, enormous public health costs, and high rates of suicide. The single most
potent risk factor for the development of bipolar disorder is a first-degree family member
with the illness; indeed, offspring of parents with bipolar disorder are a particularly
high-risk group who typically display early onset and severe course of illness. Thus, early
assessment and intervention for the children of parents with bipolar disorder focused on
specific, measurable, and modifiable risk factors has the potential to prevent or ameliorate
the progression of bipolar disorder in those at highest risk.
The most potent risk factor for the development of bipolar disorder (BP) is a first-degree
family member with the illness. Thus, offspring of parents with BP are a particularly
high-risk group and typically experience early illness onset, severe course, and high rates
of comorbid psychiatric disorders. It is well-established that poor sleep regulation is
associated with the onset of depressive and manic episodes among individuals with a
biological vulnerability to mood disorder. Furthermore, evidence supports sleep disturbance
in at-risk youth who have not yet developed threshold mood disorders. The proposed study aims
to address this core disturbance that we argue puts at-risk youth at even greater risk for
development of BP—sleep and social rhythm disruption. Since adolescence is a period
characterized by significant alterations in sleep/wake patterns and social routines, this
period may prove optimal for assessment and treatment of sleep and psychiatric symptoms in
those at-risk. The investigators adapted and piloted Interpersonal and Social Rhythm Therapy
(IPSRT), an empirically-supported treatment for adults with BP that helps patients stabilize
sleep/wake cycles and daily routines, for at-risk adolescents. Preliminary data indicate this
approach holds promise for youth at-risk for the development of BP. The investigators also
identified intervention for the heterogeneous conditions antecedent to BP as a second path to
preventing or delaying BP onset in at-risk youth. The purpose of the proposed study is thus
to further develop and examine IPSRT for the adolescent (age 12-18) offspring of parents with
BP. The study involves conduct of a small controlled trial (n=50) comparing Brief IPSRT +
Data-Informed Referral versus Data-Informed Referral alone to gather preliminary data on
feasibility, acceptability and proximal outcomes associated with the intervention. All
participants receive a thorough assessment of psychopathology and sleep disturbance (via
objective and subjective methods) at baseline, followed by a single feedback session
reviewing the findings. As clinically indicated, youth will be offered Data-Informed Referral
for any psychiatric symptoms/disorders identified during the intake assessment. Youth will
then be randomized to receive either Brief IPSRT or no Brief IPSRT; randomization will be
stratified on sleep disturbance and psychopathology. Outcomes will be assessed at 4 time
points over 6 months in all participants. Data will be used to inform the design and conduct
of a future controlled trial. The proposed approach is in direct accord with strategies
outlined in the National Institute of Mental Health (NIMH) Strategic Plan in which the
development and testing of innovative interventions to reduce risk and positively alter
trajectories of mental illness are informed by research findings regarding robust and
malleable risk factors and core features of disease. Research in this area is of great public
health importance, as it has the potential to prevent, delay, or ameliorate the progression
of this chronic and devastating illness in those at highest risk.
family member with the illness. Thus, offspring of parents with BP are a particularly
high-risk group and typically experience early illness onset, severe course, and high rates
of comorbid psychiatric disorders. It is well-established that poor sleep regulation is
associated with the onset of depressive and manic episodes among individuals with a
biological vulnerability to mood disorder. Furthermore, evidence supports sleep disturbance
in at-risk youth who have not yet developed threshold mood disorders. The proposed study aims
to address this core disturbance that we argue puts at-risk youth at even greater risk for
development of BP—sleep and social rhythm disruption. Since adolescence is a period
characterized by significant alterations in sleep/wake patterns and social routines, this
period may prove optimal for assessment and treatment of sleep and psychiatric symptoms in
those at-risk. The investigators adapted and piloted Interpersonal and Social Rhythm Therapy
(IPSRT), an empirically-supported treatment for adults with BP that helps patients stabilize
sleep/wake cycles and daily routines, for at-risk adolescents. Preliminary data indicate this
approach holds promise for youth at-risk for the development of BP. The investigators also
identified intervention for the heterogeneous conditions antecedent to BP as a second path to
preventing or delaying BP onset in at-risk youth. The purpose of the proposed study is thus
to further develop and examine IPSRT for the adolescent (age 12-18) offspring of parents with
BP. The study involves conduct of a small controlled trial (n=50) comparing Brief IPSRT +
Data-Informed Referral versus Data-Informed Referral alone to gather preliminary data on
feasibility, acceptability and proximal outcomes associated with the intervention. All
participants receive a thorough assessment of psychopathology and sleep disturbance (via
objective and subjective methods) at baseline, followed by a single feedback session
reviewing the findings. As clinically indicated, youth will be offered Data-Informed Referral
for any psychiatric symptoms/disorders identified during the intake assessment. Youth will
then be randomized to receive either Brief IPSRT or no Brief IPSRT; randomization will be
stratified on sleep disturbance and psychopathology. Outcomes will be assessed at 4 time
points over 6 months in all participants. Data will be used to inform the design and conduct
of a future controlled trial. The proposed approach is in direct accord with strategies
outlined in the National Institute of Mental Health (NIMH) Strategic Plan in which the
development and testing of innovative interventions to reduce risk and positively alter
trajectories of mental illness are informed by research findings regarding robust and
malleable risk factors and core features of disease. Research in this area is of great public
health importance, as it has the potential to prevent, delay, or ameliorate the progression
of this chronic and devastating illness in those at highest risk.
Inclusion Criteria:
1. age between 12-18 years;
2. primary residence with a parent or guardian;
3. English language fluency and at minimum a 3rd grade literacy level. Subjects must be
able to speak and understand English because one of the study interventions, Brief
IPSRT, is an experimental talk-therapy. This therapy cannot practically be translated;
4. a biological parent with a diagnosis of Bipolar Disorder I, II or Not Otherwise
Specified (NOS) confirmed via semi-structured diagnostic interview;
5. able and willing to give informed consent/assent to participate.
Exclusion Criteria:
1. a current or lifetime bipolar spectrum disorder diagnosis (i.e., Bipolar Disorder I,
II or NOS) by the Schedule for Affective Disorders and Schizophrenia-Present and
Lifetime Version (K-SADS-PL);
2. a primary sleep disorder diagnosis by the Structured Interview for DSM-IV Sleep
Disorders;
3. current unstabilized psychiatric symptoms as evidenced by a CGI-Severity of > 5
(markedly ill) and/or a C-GAS rating of < 50 (denotes serious symptoms);
4. evidence of mental retardation, pervasive developmental disorder, or organic central
nervous system disorder by the K-SADS-PL, parent report, medical history, or school
records,
5. a prior course of IPSRT treatment
6. the absence of parental participation for 18 year old potential participants (i.e. 18
year old adolescent subjects need a biological parent with a diagnosis of Bipolar
Disorder I, II or Not Otherwise Specified (NOS) to particpate in the study in order
for the adolescent to be able to participate) -
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