Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06176638
Other study ID # 202307081
Secondary ID 1K01MH131872-01A
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date June 30, 2027

Study information

Verified date December 2023
Source Washington University School of Medicine
Contact Nhial T Tutlam, PhD
Phone 314-935-3714
Email ntutlam@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this type I hybrid effectiveness-implementation trial is to test a family strengthening (FS) model delivered through multiple family groups (MFG) combined with a virtual peer mentoring program called TeenAge Health Consultants (Virtual TAHC) aimed at addressing emotional and behavioral problems among youth born in the U.S. to parents resettled as refugees. The specific aims of the study are: Aim 1: To systematically adapt an evidence-based family strengthening (FS) model delivered through multiple family groups (MFG) combined with a peer mentoring program (Virtual TAHC) (Goal 1). Aim 2: To assess preliminary short- and long-term impact of the combination intervention (MFG + Virtual TAHC) on behavioral emotional disorders (aggressive behavior, antisocial behaviors, anxiety, depression, and Posttraumatic Stress Disorder [PTSD]) related to intergenerational trauma among SGRC in the trial (Goal 2). Aim 3: Utilizing mixed methods and applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, examine implementation strategies, facilitators, and barriers of the RRF4H intervention (Goal 3). Participants will receive: 1. Family strengthening intervention delivered through multiple family groups (MFG) where children and one of their biological parents will participate in 16 weekly group sessions to discuss common problems and how to address them. 2. The youth in the intervention will participate in a peer mentorship program called TeenAge Health Consultants (TAHC) consisting of 16 weekly virtual sessions where they interact with other youth to learn about important topics including how to deal with conflict, stay out of trouble, deal with stress, avoid drugs and other topics. Researchers will compare the intervention group to a control group that will receive the usual care to see if the intervention group shows improvement in symptoms compared to the usual care group.


Description:

This is a type 1hybrid effectiveness-implementation trial to test a combination intervention designed to improve intergenerational trauma-related mental health symptoms among second generation refugee children (SGRC). Guided by Social Action and Family Systems theories, and applying them to the ITT framework, the proposed combination intervention consists of: family strengthening (FS) model delivered through multiple family groups (MFG) + peer mentoring program called TeenAge Health Consultants (TAHC) adapted for delivery in virtual environment (Virtual TAHC). The proposed study, titled Resettled Refugee Families for Healing (RRF4H): A Study of Intergenerational Impact of War Trauma and Resilience, will target refugee families resettled in Omaha and Lincoln, Nebraska. Using a two-arm randomized controlled trial, the investigators plan to recruit 154 children (77 per study arm), ages 14 - 17 and at least one biological parent per youth from resettled refugee communities. The intervention will be implemented over 16 weeks, with assessments at baseline, 16 weeks, and 6 months follow-up. The intervention will have the following specific aims: (1) systematically adapt an evidence-based family strengthening (FS) model delivered through multiple family groups (MFG) combined with a peer mentoring program (Virtual TAHC) (Goal 1); (2) assess preliminary short- and long-term impact of the combination intervention (MFG + Virtual TAHC) on behavioral emotional disorders (aggressive behavior, antisocial behaviors, anxiety, depression, and Posttraumatic Stress Disorder [PTSD]) related to intergenerational trauma among SGRC in the trial (Goal 2); and (3) utilizing mixed methods and applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, examine implementation strategies, facilitators, and barriers of the RRF4H intervention (Goal 3).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 308
Est. completion date June 30, 2027
Est. primary completion date August 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 17 Years
Eligibility Inclusion Criteria for Children: - Child born in the US - Ages 14-17 years - In the 9th - 12th grades - Enrolled in one of the schools in Omaha and Lincoln, NE area Schools Inclusion Criteria for Peer Mentors: - Peer mentors must be students in upper class (11th or 12th grade) and - Willing and able to serve as good role models - Peer mentors must be nominated by community leaders Inclusion Criteria for Parents: - Parents must be someone resettled in the U.S. as refugee and be a biological parent of a child between the ages 14-17 years - Parents must be =30 years of age Exclusion Criteria for All Participants: - Can understand the study procedures and/or participant rights during the informed consent process - Unwilling or unable to commit to completing the study; 2) - Present with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation.

Study Design


Intervention

Behavioral:
RRF4H Combination Intervention
MFG: is a family strengthening model where children and their parents sit together in groups of 8 to 10 families to discuss important issues. MFG approach provides a social support mechanism and strengthens family relationships by allowing families to share common experiences as well as effective strategies for addressing difficult issues; and focuses on reducing stigma and normalizing common experiences. TAHC: This is a peer-led program that allows younger students to talk with peers about important issues that they face, gain role models, and identify positive social norms from older peers. It provides age-appropriate lessons and is delivered in a structured fashion. The curriculum consists of sixteen 50-minute lessons spread out over two academic years. Topics delivered in the curriculum include substance use, positive outlook on life, forming a positive self-concept, decision making and problem solving, coping with depression, bullying and social media.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine National Institute of Mental Health (NIMH)

References & Publications (70)

Abur W. Settlement strategies for the South Sudanese community in Melbourne: an analysis of employment and sport participation. Melbourne: Victoria University. 2018.

Betancourt TS, Berent JM, Freeman J, Frounfelker RL, Brennan RT, Abdi S, Maalim A, Abdi A, Mishra T, Gautam B, Creswell JW, Beardslee WR. Family-Based Mental Health Promotion for Somali Bantu and Bhutanese Refugees: Feasibility and Acceptability Trial. J Adolesc Health. 2020 Mar;66(3):336-344. doi: 10.1016/j.jadohealth.2019.08.023. Epub 2019 Nov 5. — View Citation

Bowers ME, Yehuda R. Intergenerational Transmission of Stress in Humans. Neuropsychopharmacology. 2016 Jan;41(1):232-44. doi: 10.1038/npp.2015.247. Epub 2015 Aug 17. — View Citation

Bronstein I, Montgomery P. Psychological distress in refugee children: a systematic review. Clin Child Fam Psychol Rev. 2011 Mar;14(1):44-56. doi: 10.1007/s10567-010-0081-0. — View Citation

Buchanan RL, Smokowski PR. Pathways from acculturation stress to substance use among latino adolescents. Subst Use Misuse. 2009;44(5):740-62. doi: 10.1080/10826080802544216. — View Citation

Caselli LT, Motta RW. The effect of PTSD and combat level on Vietnam veterans' perceptions of child behavior and marital adjustment. J Clin Psychol. 1995 Jan;51(1):4-12. doi: 10.1002/1097-4679(199501)51:13.0.co;2-e. — View Citation

Chacko A, Gopalan G, Franco L, Dean-Assael K, Jackson J, Marcus S, Hoagwood K, McKay M. Multiple Family Group Service Model for Children With Disruptive Behavior Disorders: Child Outcomes at Post-Treatment. J Emot Behav Disord. 2015 Jun;23(2):67-77. doi: 10.1177/1063426614532690. — View Citation

Clarahan W, Christenson JD. Family involvement in the treatment of adolescent substance abuse. In: Family therapy with adolescents in residential treatment. Springer; 2017:231-243

Collins LM, Schafer JL, Kam CM. A comparison of inclusive and restrictive strategies in modern missing data procedures. Psychol Methods. 2001 Dec;6(4):330-51. — View Citation

Cro S, Morris TP, Kenward MG, Carpenter JR. Sensitivity analysis for clinical trials with missing continuous outcome data using controlled multiple imputation: A practical guide. Stat Med. 2020 Sep 20;39(21):2815-2842. doi: 10.1002/sim.8569. Epub 2020 May 17. — View Citation

Cuijpers P. Peer-led and adult-led school drug prevention: a meta-analytic comparison. J Drug Educ. 2002;32(2):107-19. doi: 10.2190/LPN9-KBDC-HPVB-JPTM. — View Citation

Daud A, Skoglund E, Rydelius PA. Children in families of torture victims: Transgenerational transmission of parents' traumatic experiences to their children. International Journal of Social Welfare. 2005;14(1):23-32.

Dekel R, Goldblatt H. Is there intergenerational transmission of trauma? The case of combat veterans' children. Am J Orthopsychiatry. 2008 Jul;78(3):281-9. doi: 10.1037/a0013955. — View Citation

Diggle P, Heagerty P, Liang K, Zeger S. Analysis of Longitudinal Data: Oxford University Press.[Google Scholar]. 2002

Enders CK. Applied Missing Data Analysis. New York: Guilford Press; 2010.

Ensor MO. South Sudanese diaspora children: Contested notions of childhood, uprootedness, and belonging among young refugees in the US. In: Contested childhoods: Growing up in migrancy. Springer, Cham; 2016:61-77.

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. — View Citation

First MB. QuickSCID-5: Quick Structured Clinical Interview for DSM-5 Disorders. American Psychiatric Association Publishing; 2021.

Fosados R, McClain A, Ritt-Olson A, Sussman S, Soto D, Baezconde-Garbanati L, Unger JB. The influence of acculturation on drug and alcohol use in a sample of adolescents. Addict Behav. 2007 Dec;32(12):2990-3004. doi: 10.1016/j.addbeh.2007.06.015. Epub 2007 Jun 9. — View Citation

Gopalan G, Bornheimer LA, Acri MC, Winters A, O'Brien KH, Chacko A, McKay MM. Multiple family group service delivery model for children with disruptive behavior disorders: Impact on caregiver stress and depressive symptoms. J Emot Behav Disord. 2018 Sep;26(3):182-192. doi: 10.1177/1063426617717721. Epub 2017 Jul 10. — View Citation

Gundel BE. Sudanese refugees' psychological need and mental health care: A phenomenological study of Sudanese beliefs about psychological treatment. The University of Nebraska-Lincoln; 2016

Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol. 1971 Oct;44(526):793-7. doi: 10.1259/0007-1285-44-526-793. No abstract available. — View Citation

International Council for Refugees and Immigrants. Youth Services. 2022; https://icrius.org/programs/youth-services/. Accessed October 15, 2022.

Isobel S, Goodyear M, Furness T, Foster K. Preventing intergenerational trauma transmission: A critical interpretive synthesis. J Clin Nurs. 2019 Apr;28(7-8):1100-1113. doi: 10.1111/jocn.14735. Epub 2019 Jan 7. — View Citation

Jackson JM. Multi-family groups for multi-stressed families: Initial outcomes and future implications. Research on Social Work Practice. 2015;25(5):537-548

Jany L. Growing opioid use in Somali community spurs need for culturally relevant treatment. StarTribune2021

Keiley MK, Zaremba-Morgan A, Datubo-Brown C, Pyle R, Cox M. Multiple-Family Group Intervention for Incarcerated Male Adolescents Who Sexually Offend and Their Families: Change in Maladaptive Emotion Regulation Predicts Adaptive Change in Adolescent Behaviors. J Marital Fam Ther. 2015 Jul;41(3):324-39. doi: 10.1111/jmft.12078. Epub 2014 May 8. — View Citation

Kellermann NP. Epigenetic transmission of Holocaust trauma: can nightmares be inherited? Isr J Psychiatry Relat Sci. 2013;50(1):33-9. — View Citation

Kroll J, Yusuf AI, Fujiwara K. Psychoses, PTSD, and depression in Somali refugees in Minnesota. Soc Psychiatry Psychiatr Epidemiol. 2011 Jun;46(6):481-93. doi: 10.1007/s00127-010-0216-0. Epub 2010 Mar 31. — View Citation

Lincoln Public Schools. Student Services: Social Workers. 2021; https://home.lps.org/socialworkers. Accessed October 15, 2021

Little RJA, Rubin DB. Statistical Analysis with Missing Data. New York: John Wiley and Sons; 2002.

Luellen JK, Shadish WR, Clark MH. Propensity scores: an introduction and experimental test. Eval Rev. 2005 Dec;29(6):530-58. doi: 10.1177/0193841X05275596. — View Citation

Management Information System for Individual Development Accounts: A Feasibility Study (CSD Report No. 01-21) [computer program]. St. Louis, MO: Washington University, Center for Social Development; 2001

Marsch LA, Borodovsky JT. Technology-based Interventions for Preventing and Treating Substance Use Among Youth. Child Adolesc Psychiatr Clin N Am. 2016 Oct;25(4):755-68. doi: 10.1016/j.chc.2016.06.005. Epub 2016 Aug 3. — View Citation

Matz AK. Commentary: Do youth mentoring programs work? A review of the empirical literature. Journal of juvenile justice. 2014;3(2):83.

McCleary JS, Shannon PJ, Cook TL. Connecting Refugees to Substance Use Treatment: A Qualitative Study. Soc Work Public Health. 2016;31(1):1-8. doi: 10.1080/19371918.2015.1087906. Epub 2015 Dec 14. — View Citation

McKay MM, Gonzales J, Quintana E, Kim L, Abdul-Adil J. Multiple family groups: An alternative for reducing disruptive behavioral difficulties of urban children. Research on Social Work Practice. 1999;9(5):593-607.

McKay MM, Gonzales JJ, Stone S, Ryland D, Kohner K. Multiple family therapy groups: A responsive intervention model for inner city families. Social Work with Groups. 1995;18(4):41-56

Milner K, Khawaja NG. Sudanese refugees in Australia: The impact of acculturation stress. Journal of Pacific Rim Psychology. 2010;4(1):19-29

Minnesota State Epidemiological Outcomes Workgroup. Epidemiological Profile of Substance Use +Related Factors among Minnesota's Somali Youth. In: Minnesota Schools ea, ed. Saint Paul2017.

MIS IDA Operations Manual: Management Information System for Individual Development Accounts, Version 5 [Computer Software Manual] [computer program]. St. Louis, MO: Washington University, Center for Social Development; 2006

Motta R. Personal and intrafamilial effects of the Vietnam war experience. The Behavior Therapist. 1990;13:155-157.

New Life Family Alliance. Youth Programs. 2022; https://nlfaomaha.org/youth-programs. Accessed October 15, 2022

Omaha Public Schools. Student and Community Services: School Counseling. 2021; https://www.ops.org/site/Default.aspx?PageID=557. Accessed October 15, 2021

Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. analysis and examples. Br J Cancer. 1977 Jan;35(1):1-39. doi: 10.1038/bjc.1977.1. — View Citation

Poppitt G, Frey R. Sudanese adolescent refugees: Acculturation and acculturative stress. Journal of Psychologists and Counsellors in Schools. 2007;17(2):160-181.

Priest N, Paradies Y, Trenerry B, Truong M, Karlsen S, Kelly Y. A systematic review of studies examining the relationship between reported racism and health and wellbeing for children and young people. Soc Sci Med. 2013 Oct;95:115-27. doi: 10.1016/j.socscimed.2012.11.031. Epub 2012 Dec 19. — View Citation

Reid CA, Lorraine Beyer, Nick Crofts, Gary. Ethnic communities' vulnerability to involvement with illicit drugs. Drugs: education, prevention and policy. 2001;8(4):359-374.

Roberts AL, Galea S, Austin SB, Cerda M, Wright RJ, Rich-Edwards JW, Koenen KC. Posttraumatic stress disorder across two generations: concordance and mechanisms in a population-based sample. Biol Psychiatry. 2012 Sep 15;72(6):505-11. doi: 10.1016/j.biopsych.2012.03.020. Epub 2012 Apr 21. — View Citation

Rodriguez G, Goldman N. An Assessment of Estimation Procedures for Multilevel Models with Binary Responses. Journal of the Royal Statistical Society Series a-Statistics in Society. 1995;158:73-89.

Rosenheck R, Nathan P. Secondary traumatization in children of Vietnam veterans. Hosp Community Psychiatry. 1985 May;36(5):538-9. doi: 10.1176/ps.36.5.538. No abstract available. — View Citation

Rosenheck R, Thomson J. "Detoxification" of Vietnam War trauma: a combined family-individual approach. Fam Process. 1986 Dec;25(4):559-70. doi: 10.1111/j.1545-5300.1986.00559.x. — View Citation

Roth M, Neuner F, Elbert T. Transgenerational consequences of PTSD: risk factors for the mental health of children whose mothers have been exposed to the Rwandan genocide. Int J Ment Health Syst. 2014 Apr 1;8(1):12. doi: 10.1186/1752-4458-8-12. — View Citation

Sack WH, Clarke GN, Seeley J. Posttraumatic stress disorder across two generations of Cambodian refugees. J Am Acad Child Adolesc Psychiatry. 1995 Sep;34(9):1160-6. doi: 10.1097/00004583-199509000-00013. — View Citation

Sangalang CC, Vang C. Intergenerational Trauma in Refugee Families: A Systematic Review. J Immigr Minor Health. 2017 Jun;19(3):745-754. doi: 10.1007/s10903-016-0499-7. — View Citation

SAS Institute. BASE SAS 9.4 Procedures Guide. Cary, NC: SAS Institute, Inc.; 2013.

Sowey H. Are refugees at increased risk of substance misuse. Sydney: Drug and Alcohol Multicultural Education Centre. 2005

Spencer JH, Le TN. Parent refugee status, immigration stressors, and Southeast Asian youth violence. J Immigr Minor Health. 2006 Oct;8(4):359-68. doi: 10.1007/s10903-006-9006-x. — View Citation

Ssewamala FM, Bermudez LG, Neilands TB, Mellins CA, McKay MM, Garfinkel I, Sensoy Bahar O, Nakigozi G, Mukasa M, Stark L, Damulira C, Nattabi J, Kivumbi A. Suubi4Her: a study protocol to examine the impact and cost associated with a combination intervention to prevent HIV risk behavior and improve mental health functioning among adolescent girls in Uganda. BMC Public Health. 2018 Jun 5;18(1):693. doi: 10.1186/s12889-018-5604-5. — View Citation

Tolan P, Henry D, Schoeny M, Bass A, Lovegrove P, Nichols E. Mentoring interventions to affect juvenile delinquency and associated problems: A systematic review. Campbell Systematic Reviews. 2013;9(1):1-158.

Tutlam NT, Chang JJ, Byansi W, Flick LH, Ssewamala FM, Betancourt TS. War-Affected South Sudanese in Settings of Preflight, Flight, and Resettlement: a Systematic Review and Meta-analysis of Trauma-Associated Mental Disorders. Global Social Welfare. 2022:1-18.

Tutlam NT, Flick LH, Xian H, Matsuo H, Glowinski A, Tutdeal N. Trauma-Associated Psychiatric Disorders Among South Sudanese Dinka and Nuer Women Resettled in the USA. Global Social Welfare. 2020;7(3):189-199.

Tutlam NT, Flick LH, Xian H, Matsuo H, Tutdeal N, Glowinski A. Emotional and Behavioral Disorders Among US-Born Children of South Sudanese Parents Resettled as Refugees. Global Social Welfare. 2022:1-10.

Tutlam NT, Liu Y, Nelson EJ, Flick LH, Chang JJ. The Effects of Race and Ethnicity on the Risk of Large-for-Gestational-Age Newborns in Women Without Gestational Diabetes by Prepregnancy Body Mass Index Categories. Matern Child Health J. 2017 Aug;21(8):1643-1654. doi: 10.1007/s10995-016-2256-x. — View Citation

Tutlam NT. The Impact of Maternal War Trauma on Children: A Study of South Sudanese Families Resettled in the US, Saint Louis University; 2017

van der Laan M, Rose S. Targeted Learning: Causal Inference for Observational and Experimental Data. New York, NY: Springer; 2011.

van IJzendoorn MH, Bakermans-Kranenburg MJ, Sagi-Schwartz A. Are children of Holocaust survivors less well-adapted? A meta-analytic investigation of secondary traumatization. J Trauma Stress. 2003 Oct;16(5):459-69. doi: 10.1023/A:1025706427300. — View Citation

Weine S, Kulauzovic Y, Klebic A, Besic S, Mujagic A, Muzurovic J, Spahovic D, Sclove S, Pavkovic I, Feetham S, Rolland J. Evaluating a multiple-family group access intervention for refugees with PTSD. J Marital Fam Ther. 2008 Apr;34(2):149-64. doi: 10.1111/j.1752-0606.2008.00061.x. — View Citation

Westfall PH, Young SS. Resmpling Based Multiple Testing: Examples and Methods for p-value Adjustment. New York, NY: John Wiley and Sons; 1993

Wilhelm AK, McRee AL, Bonilla ZE, Eisenberg ME. Mental health in Somali youth in the United States: the role of protective factors in preventing depressive symptoms, suicidality, and self-injury. Ethn Health. 2021 May;26(4):530-553. doi: 10.1080/13557858.2018.1514451. Epub 2018 Aug 24. — View Citation

* Note: There are 70 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Intervention Feasibility Intervention feasibility will be measured using Recruitment rates; proportion eligible and enrolled (=70% enrollment considered feasible) Baseline, 16 Weeks post-intervention, and 6 months
Other Intervention Acceptability Intervention acceptability will be assessed using Client Satisfaction Questionnaire (CSQ-8; to be adapted). Scores range from 8 to 32 with higher score indicating higher degree of satisfaction/acceptability/ 6 months post-intervention
Primary Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adolescents Change in symptoms of post-traumatic stress disorder (PTSD) will be assessed using Posttraumatic Stress Disorder Reaction Index (PTSD-RI) for adolescents. PTSD scores will be dichotomized between meeting diagnostic criteria for PTSD (>=35) and not meeting diagnostic criteria for PTSD (<35). Baseline, 16 Weeks post-intervention, and 6 months
Primary Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adults Change in symptoms of post-traumatic stress disorder (PTSD) will be assessed using the Harvard Trauma Questionnaire (HTQ). PTSD score will be dichotomized between meeting diagnostic criteria for PTSD >=2.0 and not meeting diagnostic criteria for PTSD <2.0. Baseline, 16 Weeks post-intervention, and 6 months
Primary Improvement in Depression Symptoms among adults Changes in depression symptoms will be measured using the Hopkins symptoms checklist 25. Depression score will be dichotomized between meeting diagnostic criteria for depression (>=1.75) and not meeting diagnostic criteria for depression (<1.75). Baseline, 16 Weeks post-intervention, and 6 months
Primary Improvement in Depression Symptoms among adolescents Changes in depression symptoms will be measured using Hopkins symptoms checklist 37. There is no set clinical cut-off level, but higher score indicates symptoms severity. Baseline, 16 Weeks post-intervention, and 6 months
Primary Improvement in Anxiety Symptoms among adults Changes in anxiety symptoms will be measured using Hopkins symptoms checklist 25. Anxiety score will be dichotomized between meeting diagnostic criteria for anxiety (>=1.75) and not meeting diagnostic criteria or anxiety (<1.75) Baseline, 16 Weeks post-intervention, and 6 months
Primary Improvement in Anxiety Symptoms among adolescents Changes in depression symptoms will be measured using Hopkins symptoms checklist 37. There is no set clinical cut-off level, but higher score indicates symptoms severity. Baseline, 16 Weeks post-intervention, and 6 months
Primary Improvements in Antisocial Behavior Symptoms (adolescents only) Changes in antisocial behavior will be assessed using the Child Behavior Checklist for ages 6 to 18 years. T-scores will be dichotomized between abnormal range (T-score >=69) and normal range (T-score <69). Baseline, 16 Weeks post-intervention, and 6 months
Primary Improvement in Aggressive Behavior Symptoms (adolescents only) Changes in aggressive behavior will be assessed using the Child Behavior Checklist for ages 6 to 18 years. T-scores will be dichotomized between abnormal range (T-score >=69) and normal range (T-score <69). Baseline, 16 Weeks post-intervention, and 6 months
Secondary Improvement in Family Cohesion Change in family cohesion will be assessed using family cohesion scale. This is a 6-item scale with possible scores ranging from 6 to 30 and higher score indicates higher degree of family cohesion. Baseline, 16 Weeks post-intervention, and 6 months
Secondary Improvement in Social Social Support Change in family and social support will be assessed using Multidimensional scale of perceived social support. Scores range from 12 to 84 with higher score indicating higher social support. Baseline, 16 Weeks post-intervention, and 6 months
Secondary Improvement in Family and Social Support Change in family and social support will be assessed using University of California, Los Angeles (UCLA) Loneliness Scale, version 3. Scores range from 20 to 80 with higher score indicating higher loneliness. Baseline, 16 Weeks post-intervention, and 6 months
Secondary Improvement in Family Communication Change in family communication will be assessed using Child-Adolescent Communication Scale. Two subscales: 1) degree of openness: with higher score indicating better communication (scores range from 10 to 40); and 2) extent of problems with higher score indicating more problems in parent-child communication (scores range from 10 to 50). Baseline, 16 Weeks post-intervention, and 6 months
Secondary Improvement in Family Functioning Change in family functioning will be assessed using six healthy general functioning items from the McMaster Family Assessment Device with possible scores ranging from 6 to 24 and lower score indicating healthy functioning. Baseline, 16 Weeks post-intervention, and 6 months
Secondary Mental Health Stigma Change in stigma symptoms will be assessed using the Paediatric Self-Stigmatization Scale. Scores range from 31 to 114 with higher score indicating high degree of stigmatization. Baseline, 16 Weeks post-intervention, and 6 months
Secondary Improvement in Self-Concept Change in Self-Concept will be assessed using Tennessee Self-Concept Scale. This is a 20-item scale with scores ranging from 20 to 100 and higher score indicating higher self-concept. Baseline, 16 Weeks post-intervention, and 6 months
Secondary Improvement in Self-efficacy Change in Self-Efficacy will be assessed using the General Self-Efficacy Scale, a 10-item scale with scores ranging from 10 to 40 and higher score indicating higher self-efficacy. Baseline, 16 Weeks post-intervention, and 6 months
Secondary Improvement in Hopelessness Change in hopelessness will be measured using Beck Hopelessness Scale. Scores range from 20 to 40 with higher score indicating higher degree of hopelessness. Baseline, 16 Weeks post-intervention, and 6 months
Secondary Improved peer support/relationships Change in peer support relationship will be assessed using Strengths and Difficulties Questionnaire (SDQ). Scores for this subscale range from 5 to 25 with higher score indicating higher degree of peer relationships. Baseline, 16 Weeks post-intervention, and 6 months
Secondary Improved prosocial attitudes/conduct problems Change in prosocial attitudes/conduct problems will be measured using the Strengths and Difficulties Questionnaire (SDQ). Scores for this subscale range from 5 to 25 with higher score indicating higher degree of peer relationships. Baseline, 16 Weeks post-intervention, and 6 months
Secondary Exposure to Potentially Traumatic Events (PTE) Number of traumatic events participants are exposed to will be measured using the UCLA posttraumatic stress disorder reaction index (PTSD-RI). Higher score indicates high number of traumatic events. Baseline, 16 Weeks post-intervention, and 6 months
Secondary Exposure to Adverse Childhood Experiences (ACEs) Number of Adverse Childhood Experiences (ACEs) will be measured using Adverse Childhood Experience (ACEs) scale. Possible scores range from 1 to 10 with high number indicating higher ACEs score. Baseline, 16 Weeks post-intervention, and 6 months
Secondary Change in Risk-taking Behaviors Change in Risk-Taking Behaviors will be assessed using the Youth Risk Behavior Survey. Baseline, 16 Weeks post-intervention, and 6 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A