Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT00919594
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria (Mothers)
1. Adult female, age 18-65
2. Biological or adoptive mother of child, age 7-18, who meets child inclusion criteria (see below)
3. Lives with and has custody of the eligible child participant
4. Currently in an episode of major depression, as defined by the DSM-IV and documented by the use of the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I)
5. Score \> or equal to 15 on the 25-item Hamilton Rating Scale for Depression (HRSD-25)
6. Ability and willingness to give informed, written consent
7. Willingness to give informed consent for their eligible and assenting child to participate
Inclusion Criteria (Psychiatrically Ill Children)
1. Age 7-18
2. Currently meets criteria for at least one current depressive or anxiety disorder as defined by the DSM-IV (American Psychiatric Association, 1994) and documented by the Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Lifetime version (K-SADS-PL)
3. Willingness to provide informed consent/assent
Exclusion Criteria:
Exclusion Criteria (Mothers)
1. If a mother subject IS NOT on antidepressants:
Mothers must be off all antidepressant medications for at least 14 days (30 days for fluoxetine) prior to screening to ensure that pretreatment assessments are not distorted by drug withdrawal or rebound effects). Mother subjects cannot start taking antidepressant medications during the acute treatment phase. If they do start taking antidepressant medication during the acute treatment portion of the study, their participation in the acute phase of the study will be terminated. They will be continued to be followed in the follow-up phase.
If a mother subject IS on antidepressants:
Mothers must be on a stable dose of an antidepressant medication (4 consecutive weeks at the same dose) prior to signing consent. The mother subject must agree to stay on the same antidepressant at this current dose throughout the duration of the acute phase of the study. If a participant's dosage of an antidepressant medication is changed or if they cease taking their antidepressant medication during the acute treatment portion of the study, their participation in the acute phase of the study will be terminated. They will be continued to be followed in the follow-up phase.
2. Active suicidal ideation or homicidal ideation that in the clinical opinion of the research team as headed by the PI, would require hospitalization
3. At serious risk for child abuse or neglect which in the clinical opinion of the research team as headed by the PI, requires intervention
4. Comorbid psychotic disorder, organic mental disorder, current (within prior six months) substance or alcohol abuse, borderline personality disorder, antisocial personality disorder, or history of a prior manic episode (bipolar disorder)
5. Significant medical illness that might explain depressive symptoms such as epilepsy, autoimmune disorders, or unstable endocrine disease
6. Not fluent in English. The intervention to be tested in this study is psychotherapy. The staff is only trained to deliver these interventions in English. Thus, all subjects must be fluent in English.
7. Severe cognitive deficits that would preclude treatment with psychotherapy and/or prevent completion of study questionnaires
8. Current receipt of another form of individual psychotherapy; concurrent participation in a support group (such as Alcoholics Anonymous), couples therapy, or family therapy will be permitted
9. Currently in an abusive relationship as determined by the domestic violence questionnaire and/or PI's judgment
10. Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
Exclusion Criteria (Psychiatrically Ill Children)
1. Meets criteria for mental retardation, autistic disorder, schizophrenia, or current (within prior 6 months) substance or alcohol abuse
2. Significant cognitive impairment or learning delays that would prevent completion of study questionnaires
3. Significant chronic medical illness that might explain depressive or anxiety symptoms such as sickle cell anemia, cystic fibrosis, or leukemia; children with moderate medical illnesses may be included in the study if the PI determines it is of no greater risk to the child's medical illness
4. Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
65 Years
Study:
NCT00919594
Study Brief:
Protocol Section:
NCT00919594