Fristad, M. A. (2006). Psychoeducational treatment for school-aged children with bipolar disorder. Development and Psychopathology, 18, 1289-1306. doi:10.1017/S0954579406060627 

Type of Study: Randomized controlled trial
Number of Participants: 20 children (and their families)

Population:

• Age — 8-11 years
• Race/Ethnicity — 90% Caucasian
• Gender — 85% Male and 15% Female
• Status — Participants were children with primary mood disorder diagnoses including bipolar I disorder, bipolar II disorder, and bipolar disorder, not otherwise specified.

Location/Institution: Academic health center

Summary: (To include basic study design, measures, results, and notable limitations)
Participants were randomized, by pairs, into the Individual Family Psychoeducation (IFP, otherwise known as Individual Family - Psychoeducational Psychotherapy (PEP)) plus treatment as usual (IFP + TAU, n = 10) condition, or into a waitlist-control condition plus TAU (WLC + TAU, n = 10) Measures included the Children's Interview for Psychiatric Syndromes – Child and Parent Forms; the Children's Depression Rating Scale – Revised (CDRS-R) and Mania Rating Scale (MRS) in order to assess severity of mood impairment; and Mood Severity Index (MSI), which measured overall mood severity. Also, the Expressed Emotion Adjective Checklist (EEAC) assessed family expressed emotion (EE). Follow-up assessments of both groups were conducted 6 months after study entry, at 12 months, and at 18 months. After 12 months, the WLC + TAU group received IFP. Results showed that children's mood improved immediately following treatment, with gains continuing for 12 months post-IFP. Additionally, families who received immediate IFP treatment showed higher scores on the EEAC, which reflects better family climate. Limitations include the small sample size, which made the findings described above not statistically significant and does not establish the practice's benefit over the control group.

Length of controlled postintervention follow-up: 12 months (treatment group) and 6 months (WLC group).

Leffler, J. M., Fristad, M. A. & Klaus, N. M. (2010). Psychoeducational Psychotherapy (PEP) for children with bipolar disorder: Two case studies. Journal of Family Psychotherapy, 21(4). doi:10.1080/08975353.2010.529051

Type of Study: Case studies
Number of Participants: 2

Population:

• Age — 8-12 years
• Race/Ethnicity — White
• Gender — 1 Male and 1 Female
• Status — Female participant had baseline mood diagnosis of bipolar disorder, most recent episode-mixed; male participant had a baseline diagnosis of bipolar disorder, most recent episode-hypomanic.

Location/Institution: Academic health center

Summary: (To include basic study design, measures, results, and notable limitations)
Two children presenting with bipolar disorder were treated with an expanded version of Individual Family - Psychoeducational Psychotherapy (PEP), lengthened from 16 to 24 sessions. Measures included the Children's Interview for Psychiatric Syndromes-Child and Parent (ChIPS & P-ChIPS) forms, which are structured psychiatric interviews to assess psychopathology according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria with parents of children and adolescents. The Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children – Mania Rating Scale (K-MRS) and Depression Rating Scale (K-DRS) were used to assess mood severity. Additionally, the Children's Global Assessment Scale (C-GAS) was used to measure the children's overall functional capacity; the Expressed Emotion Adjective Checklist (EEAC) assessed positive and negative emotions expressed by the parent and child toward each other, as reported by the parent; and the Treatment Beliefs Questionnaire- Parent and Child Forms (TBQ-P and TBQ-C) were self-report measures used to assess beliefs about treatments (pharmacologic and psychosocial). Both subject's K-MRS scores improved from pre- to post-treatment, but remained in the symptomatic range. For the K-DRS, the female subject's current functioning score was reduced by 18% from pre- to post-treatment, while the male subject's score increased by 28%. Functioning improved over time for both children, though both were still notably impaired at the end of the study. Results suggested improved family functioning, improvement in children's manic symptoms, and overall level of functioning. Limitations include the small sample size, the homogeneity in race/ethnicity (both White), and the lack of follow-up data.

Length of controlled postintervention follow-up: None.

Fristad, M. A., Young, A. S., Vesco, A. T., Nader, E. S., Healy, K. Z., Gardner, W., ... Arnold, L. E. (2015). A randomized controlled trial of Individual Family Psychoeducational Psychotherapy and omega-3 fatty acids in youth with subsyndromal bipolar disorder. Journal of Child and Adolescent Psychopharmacology, 25(10), 764-774. doi:10.1089/cap.2015.0132

Type of Study: Randomized controlled trial
Number of Participants: 23

Population:

• Age — Children: 7-14 years (Mean=10.2 years); Parents: 36-42 years (Mean=38.8 years)
• Race/Ethnicity — Children: 74% White, 13% Black/African American, 4.3% Asian, and 8.7% Other; Parents: Not specified
• Gender — Children: 57% Male, Parents: Not specified
• Status — Participants were children with bipolar disorder who were referred from clinical and community settings.

Location/Institution: Academic health center

Summary: (To include basic study design, measures, results, and notable limitations)
This study evaluates efficacy of omega-3 fatty acid supplementation (O3), Individual Family Psychoeducational Psychotherapy (IF-PEP), and their combination in youth with subsyndromal bipolar disorders (bipolar disorder not otherwise specified [BP-NOS], cyclothymic disorder. Participants were randomly assigned to one of four groups: (O3 + PEP: n = 5; O3 + Active Monitoring [AM]: n = 5; Placebo [PBO] + PEP: n = 7; PBO + AM: n = 6). Results showed combined therapy (O3+PEP) was associated with greater improvement in depressive symptoms than PBO+AM. IF-PEP demonstrated medium to large effects on depressive symptoms compared with AM. Additionally, combined therapy was more effective than O3 monotherapy, but not more effective than IF-PEP monotherapy. Limitations of the study include the small sample size, results may not be generalizable to fish oil supplements that do not utilize a 7:1 EPA:DHA ratio, and lack of follow-up.

Length of controlled postintervention follow-up: None.

Young , A. S., Arnold, E. L., Wolfson, H. L., & Fristad, M. A. (2016). Psychoeducational psychotherapy and omega-3 supplementation improve co-occurring behavioral problems in youth with depression: Results from a pilot RCT. Journal of Abnormal Child Psychology. Advance online publication. doi:10.1007/s10802-016-0203-3

Type of Study: Randomized controlled trial
Number of Participants: 72

Population:

• Age — 7-14 years
• Race/Ethnicity — 57% Caucasian, 30% African American, and 13% Biracial
• Gender — 56.9% Male
• Status — Participants were children with depression who were referred from clinical and community settings.

Location/Institution: Large Midwestern city

Summary: (To include basic study design, measures, results, and notable limitations)
This study investigated benefits of omega-3 fatty acid supplementation and Individual-Family Psychoeducational Psychotherapy (IF-PEP); a family-focused, cognitive-behavioral therapy) for behavior problems among youth with depression. Participants were block-randomized to receive combined treatment (IF-PEP + omega-3 supplementation), IF-PEP monotherapy (plus placebo), omega-3 monotherapy, or placebo alone. Measures utilized include demographic questionnaire, the Eyberg Child Behavior Inventory (ECBI), the Children's Depression Rating Scale-Revised (CDRS-R), K-SADS Depression Rating Scale (KDRS), the Swanson, Nolan, and Pelham-IV (SNAPIV). Results indicated combination treatment yielded the most robust effects across behavioral outcomes, providing preliminary support for combining these interventions in treating the severity and frequency of behavior problems overall as well as hyperactivity/impulsivity among youth with depression. Omega-3 supplementation alone may have particular promise in alleviating inattentive symptoms among youth with depression. None of the treatments had a significant effect on SNAP-IV ODD scores or ECBI Problem scores relative to placebo, although trends were evident, with combined treatment yielding medium effects. Thus, this study offers only modest support for the efficacy of omega-3 supplementation and/or PEP in treating oppositional behaviors. Limitations of the study include the small sample size, participants' depression symptoms were mild; thus, results may not be generalizable to youth with severe depression, and length of follow-up.

Length of controlled postintervention follow-up: 2, 4, 6, 9, and 12 weeks.

Fristad , M. A., Vesco, A. T., Young, A. S., Healy, Z. K., Nader, E. S., Seidenfeld, A. M., … Arnold, E. L. (2016). Pilot randomized controlled trial of omega-3 and Individual-Family Psychoeducational Psychotherapy for children and adolescents with depression. Journal of Clinical Child and Adolescent Psychology. Advance online publication. doi:10.1080/15374416.2016.1233500

Type of Study: Randomized controlled trial
Number of Participants: 72

Population:

• Age — 7-14 years
• Race/Ethnicity — 57% Caucasian, 30% African American, and 13% Biracial
• Gender — 57% Male
• Status — Participants were children with depression who were referred from clinical and community settings.

Location/Institution: Large Midwestern city

Summary: (To include basic study design, measures, results, and notable limitations)
This study uses the same sample as Young, Arnold, Wolfson, & Fristad (2016). This study evaluates the feasibility and estimate effect sizes of using omega-3 fatty acids (Ω3), Individual-Family Psychoeducational Psychotherapy (IF-PEP), and the combination of omega-3 and IF-PEP, and the moderating effects of maternal depression and psychosocial stressors in youth with depression. Participants were randomly assigned to one of four groups: IF-PEP + omega-3, IF-PEP monotherapy (with pill placebo), omega-3 monotherapy, or placebo (without active intervention). Measures utilized include demographic questionnaire, and the Mania Rating Scale (KMRS), the Children's Interview for Psychiatric Syndromes Child and Parent Versions (ChIPS/P-ChIPS), the Kaufman Brief Intelligence Test, 2nd Edition (KBIT-2), the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II), and the Family History Screen (FHS). Results indicated that combined IF-PEP + omega-3 is a promising treatment for co-occurring behavior symptoms in youth with depression. IF-PEP and Ω3, alone or in combination, did not significantly impact depressive trajectories compared to placebo alone in this pilot study, although small-medium effects were noted for Ω3 monotherapy and combined treatment relative to placebo. Limitations of the study include the small sample size, the effects of Î©3 may not be generalizable to fish oil supplements that differ in dose or EPA/DHA ratio, reliability of therapy video ratings was acceptable but not strong, results may not be generalizable to youth with severe presentations of depression, and length of follow-up.

Length of controlled postintervention follow-up: 2, 4, 6, 9, and 12 weeks.

Vesco, A. T., Young, A. S., Arnold, L. E., & Fristad, M. A. (2017). Omega–3 supplementation associated with improved parent' rated executive function in youth with mood disorders: secondary analyses of the omega 3 and therapy (OATS) trials. Journal of Child Psychology and Psychiatry, 59(6), 628-636. doi:10.1111/jcpp.12830

Type of Study: Randomized controlled trial (secondary analysis)
Number of Participants: 95

Population:

• Age — Children: 7-14 years
• Race/Ethnicity — Children: 57% Caucasian, 30% African American, and 13% Biracial; Parents: Not specified
• Gender — Children: 57% Male, Parents: Not specified
• Status — Participants were children with depression or bipolar disorder who were referred from clinical and community settings.

Location/Institution: Large Midwestern city

Summary: (To include basic study design, measures, results, and notable limitations)
This study was to assess the impact of omega-3 supplementation (Ω3) and Individual Psychoeducational Psychotherapy (PEP), each alone and in combination, on executive functioning (EF) in youth with mood disorders. Participants were randomly assigned to one of four groups: Ω3 monotherapy; PEP monotherapy with pill placebo (PBO); Combined intervention (Ω3 and PEP); or PBO-only (no study intervention). Measures utilized include demographic questionnaire, and the Behavior Rating Inventory of Executive Functioning (BRIEF), the parent-report Global Executive Composite (GEC), the K-SADS Depression (KDRS), the Mania Rating Scales (KMRS), the Children's Depression Rating Scale-Revised (CDRS-R), and Young Mania Rating Scale (YMRS). Results indicated that participants receiving Ω3 (aggregating combined and monotherapy) improved significantly more than aggregated placebo on GEC and Metacognition Indices (MI). Ω3 alone and combined with PEP each surpassed placebo on GEC. Moderation by attention-deficit/ hyperactivity disorder (ADHD) comorbidity was nonsignificant although those with ADHD showed nominally greater gains. PEP monotherapy had negligible effect. Limitations of the study include that the BRIEF, possibly reflecting parental bias, may differ from observation and performance-based tests, that the results may not generalize to an EPA:DHA ratio other than the 7:1 used in this study, issues with baseline equivalence and concerns about generalizability.

Length of controlled postintervention follow-up: None.

Young, A. S., Arnold, L. E., Wolfson, H. L., & Fristad, M. A. (2017). Psychoeducational psychotherapy and omega-3 supplementation improve co-occurring behavioral problems in youth with depression: results from a pilot RCT. Journal of Abnormal Child Psychology, 45(5), 1025-1037. doi:10.1007/s10802-016-0203-3

Type of Study: Randomized controlled trial (secondary analysis)
Number of Participants: 72

Population:

• Age — Children: 7-14 years
• Race/Ethnicity — Children: 57% Caucasian, 30% African American, and 13% Biracial; Parents: Not specified
• Gender — Children: 57% Male, Parents: Not specified
• Status — Participants were children with depression who were referred from clinical and community settings.

Location/Institution: Large Midwestern city

Summary: (To include basic study design, measures, results, and notable limitations)
This study investigated benefits of omega-3 fatty acid supplementation and Individual-Family Psychoeducational Psychotherapy (PEP) for behavior problems among youth with depression. Participants were block-randomized to receive combined treatment (IF-PEP + omega-3 supplementation), IF-PEP monotherapy (plus placebo), omega-3 monotherapy, or placebo alone. Measures utilized include a demographic questionnaire, the Eyberg Child Behavior Inventory (ECBI), the Children's Depression Rating Scale-Revised (CDRS-R), K-SADS Depression Rating Scale (KDRS), and the Swanson, Nolan, and Pelham-IV (SNAP-IV). Results showed a significant effect of combined PEP + omega-3 on SNAP-IV Total and Hyperactivity/Impulsivity trajectories, such that youth in the combined group saw greater behavioral improvement than those receiving only placebo. Similarly, youth in combined treatment had more favorable ECBI Intensity trajectories than youth who received no active treatment. Limitations of the study include that a large percentage of subjects did not compete several measures and were excluded from analyses, resulting in a smaller sample size, participants' depression symptoms were mild and thus, results may not be generalizable to youth with severe depression, and the lack of follow-up.

Length of controlled postintervention follow-up: None.