Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
8 participants
INTERVENTIONAL
2024-02-05
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The group based psychoeducational intervention is called Rare Group Problem Management Plus.
Rare Group PM Plus may help adults with practical and emotional problems. It is a group program (there will be other men or women with similar problems) It happens once a week for 5 weeks (each session lasts 90 minutes)
Participants will complete assessments before they start Rare Group PM+. Participants will also complete the same assessments within a few weeks of completing Rare Group PM+. Assessments should only take one hour.
Study visits are by Telemedicine. Participants will need a smart phone or tablet. If they do not have a smart phone or tablet, the study team will help with this.
Participants will not receive any materials or money or medication.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Group Intervention for Interpersonal Trauma
NCT00348036
Effectiveness of Group Focused Psychosocial Support for Adults Affected by Humanitarian Crises
NCT03747055
A Hybrid Effectiveness-Implementation Trial of Group CBT in Urban Schools
NCT02651402
Disrupting Fear-based Memory Consolidation
NCT05560113
Developing a Booster Session for Problem Management Plus in the Bahamas: A Pilot Randomized Controlled Trial
NCT07208851
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The group based psychoeducational intervention is called Rare Group Problem Management (PM) Plus intervention.
Rare Group PM Plus may help adults with practical and emotional problems It is a group program (there will be other men or women with similar problems) It happens once a week for 5 weeks (each session lasts 90 minutes)
Investigators will be recruiting for 3 groups of 10 families each, for a total of 30 families who will participate in this study from Children's National Hospital.
There are 7 study visits.
Study Timeline:
Study visit 1: Assessment-Before Group PM+ Study visit 2: Session 1-Managing Stress Study visit 3: Session 2-Managing Problems Study visit 4: Session 3-Get Going, Keep Doing Study visit 5: Session 4-Strengthening Social Support Study Visit 6: Session 5-Staying Well and Looking Forward Study Visit 7: Assessment within 2 weeks after complete Group PM+
Sessions will occur over Zoom Telehealth and facilitated by a licensed clinical psychologist and a genetic counselor trainee.
Investigators will use chi-square tests and Fisher's exact test to measure changes from baseline to 2 weeks post-intervention. Investigators will also collect qualitative data on what participants liked about the intervention, what they did not like, and what they think will improve the intervention.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rare Group PM Plus
Rare Group PM Plus consists of 5 weekly sessions. Each session lasts 90 minutes.
Session 1: Managing Stress Session 2: Managing Problems Session 3: Get Going, Keep Doing Session 4: Strengthening Social Support Session 5: Staying Well and Looking Forward
Rare Group Problem Management Plus
The World Health Organization's Group Problem Management Plus (Group PM+) intervention has been demonstrated to effectively provide psychological help for adults impaired by distress in communities exposed to adversity. Investigators will test an adapted model for use on-line and with family caregivers of children with rare diseases. Managing Stress. Teaching participants a brief stress management strategy will help them better manage problems related to anxiety and stress. Managing Problems. This is a strategy to apply in situations where a participant is experiencing practical problems (e.g. conflict in the family). Get Going, Keep Doing. This strategy targets depression and inactivity. Strengthening Social Support. Individuals with emotional problems can be isolated from supportive people and organizations. Strengthening social support promotes well-being. Staying Well and Looking Forward. This is a review, ends with a closing ceremony.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rare Group Problem Management Plus
The World Health Organization's Group Problem Management Plus (Group PM+) intervention has been demonstrated to effectively provide psychological help for adults impaired by distress in communities exposed to adversity. Investigators will test an adapted model for use on-line and with family caregivers of children with rare diseases. Managing Stress. Teaching participants a brief stress management strategy will help them better manage problems related to anxiety and stress. Managing Problems. This is a strategy to apply in situations where a participant is experiencing practical problems (e.g. conflict in the family). Get Going, Keep Doing. This strategy targets depression and inactivity. Strengthening Social Support. Individuals with emotional problems can be isolated from supportive people and organizations. Strengthening social support promotes well-being. Staying Well and Looking Forward. This is a review, ends with a closing ceremony.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Understands and speaks English or Spanish. Reading or health literacy is not required.
* Signed consent.
* Signed waiver of assent for child.
Exclusion Criteria
* Child with the rare disease is over the age of 21 years.
* Family caregiver is actively suicidal, homicidal, or psychotic.
* Family caregiver is impaired (cognitively or by drugs or alcohol).
* Family caregiver has a low level of distress.
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Travere Therapeutics, Inc.
INDUSTRY
Children's National Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maureen Lyon
Clinical Health Psychologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maureen Lyon, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's National Hospital
Washington D.C., District of Columbia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bogart KR, Irvin VL. Health-related quality of life among adults with diverse rare disorders. Orphanet J Rare Dis. 2017 Dec 7;12(1):177. doi: 10.1186/s13023-017-0730-1.
Bogart KR, Dermody SS. Relationship of rare disorder latent clusters to anxiety and depression symptoms. Health Psychol. 2020 Apr;39(4):307-315. doi: 10.1037/hea0000840. Epub 2019 Dec 19.
Rothrock NE, Amtmann D, Cook KF. Development and validation of an interpretive guide for PROMIS scores. J Patient Rep Outcomes. 2020 Feb 28;4(1):16. doi: 10.1186/s41687-020-0181-7.
Uhlenbusch N, Lowe B, Harter M, Schramm C, Weiler-Normann C, Depping MK. Depression and anxiety in patients with different rare chronic diseases: A cross-sectional study. PLoS One. 2019 Feb 20;14(2):e0211343. doi: 10.1371/journal.pone.0211343. eCollection 2019.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Saunders R, Moinian D, Stott J, Delamain H, Naqvi SA, Singh S, Wheatley J, Pilling S, Buckman JEJ. Measurement invariance of the PHQ-9 and GAD-7 across males and females seeking treatment for common mental health disorders. BMC Psychiatry. 2023 Apr 28;23(1):298. doi: 10.1186/s12888-023-04804-x.
Lai X, Jiang Y, Sun Y, Zhang Z, Wang S. Prevalence of depression and anxiety, and their relationship to social support among patients and family caregivers of rare bone diseases. Orphanet J Rare Dis. 2023 Jan 26;18(1):18. doi: 10.1186/s13023-022-02611-3.
Xiao SY. et al. The theoretical basis and applications of Social Support Rating Scale (SSRS). Journal of Clinical Psychiatry. 1994;4:98-100.
Kenny T, et al. The importance of psychological support for parents and caregivers of children with a rare disease diagnosis. Rare Disease and Orphan Drugs Journal. 2022;1(2):7.
Anderson M, Elliott EJ, Zurynski YA. Australian families living with rare disease: experiences of diagnosis, health services use and needs for psychosocial support. Orphanet J Rare Dis. 2013 Feb 11;8:22. doi: 10.1186/1750-1172-8-22.
Scharping M, Brennenstuhl H, Garbade SF, Wild B, Posset R, Zielonka M, Kolker S, Haun MW, Opladen T. Unmet Needs of Parents of Children with Urea Cycle Disorders. Children (Basel). 2022 May 12;9(5):712. doi: 10.3390/children9050712.
Lyon ME, Fraser JL, Thompkins JD, Clark H, Brodie N, Detwiler K, Torres C, Guerrera MF, Younge T, Aoun S, Trujillo Rivera EA. Advance Care Planning for Children With Rare Diseases: A Pilot RCT. Pediatrics. 2024 Jun 1;153(6):e2023064557. doi: 10.1542/peds.2023-064557.
Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella D. Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy--Spiritual Well-being Scale (FACIT-Sp). Ann Behav Med. 2002 Winter;24(1):49-58. doi: 10.1207/S15324796ABM2401_06.
Cooper B, Kinsella GJ, Picton C. Development and initial validation of a family appraisal of caregiving questionnaire for palliative care. Psychooncology. 2006 Jul;15(7):613-22. doi: 10.1002/pon.1001.
Toledano-Toledano F, Moral de la Rubia J, Dominguez-Guedea MT, Nabors LA, Barcelata-Eguiarte BE, Rocha-Perez E, Luna D, Leyva-Lopez A, Rivera-Rivera L. Validity and Reliability of the Beck Anxiety Inventory (BAI) for Family Caregivers of Children with Cancer. Int J Environ Res Public Health. 2020 Oct 23;17(21):7765. doi: 10.3390/ijerph17217765.
Alimujiang A, Wiensch A, Boss J, Fleischer NL, Mondul AM, McLean K, Mukherjee B, Pearce CL. Association Between Life Purpose and Mortality Among US Adults Older Than 50 Years. JAMA Netw Open. 2019 May 3;2(5):e194270. doi: 10.1001/jamanetworkopen.2019.4270.
Hill PL, Turiano NA. Purpose in life as a predictor of mortality across adulthood. Psychol Sci. 2014 Jul;25(7):1482-6. doi: 10.1177/0956797614531799. Epub 2014 May 8.
Boettcher J, Filter B, Denecke J, Hot A, Daubmann A, Zapf A, Wegscheider K, Zeidler J, von der Schulenburg JG, Bullinger M, Rassenhofer M, Schulte-Markwort M, Wiegand-Grefe S. Evaluation of two family-based intervention programs for children affected by rare disease and their families - research network (CARE-FAM-NET): study protocol for a rater-blinded, randomized, controlled, multicenter trial in a 2x2 factorial design. BMC Fam Pract. 2020 Nov 20;21(1):239. doi: 10.1186/s12875-020-01312-9.
First Michael B, et al. Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Clinical Trials Version (SCID-CT). New York: Biometrics Research, New York State Psychiatric institute, 2007.
Witt S, Schuett K, Wiegand-Grefe S, Boettcher J, Quitmann J. Living with a rare disease - experiences and needs in pediatric patients and their parents. Orphanet J Rare Dis. 2023 Aug 11;18(1):242. doi: 10.1186/s13023-023-02837-9.
Delisle VC, Gumuchian ST, Rice DB, Levis AW, Kloda LA, Korner A, Thombs BD. Perceived Benefits and Factors that Influence the Ability to Establish and Maintain Patient Support Groups in Rare Diseases: A Scoping Review. Patient. 2017 Jun;10(3):283-293. doi: 10.1007/s40271-016-0213-9.
Ashtari S, Taylor A. Patients With Rare Diseases and the Power of Online Support Groups: Implications for the Medical Community. JMIR Form Res. 2023 Sep 14;7:e41610. doi: 10.2196/41610.
Titgemeyer SC, Schaaf CP. Facebook Support Groups for Rare Pediatric Diseases: Quantitative Analysis. JMIR Pediatr Parent. 2020 Nov 19;3(2):e21694. doi: 10.2196/21694.
McCarthy SR, Golembiewski EH, Gravholt DL, Clark JE, Clark J, Fischer C, Mulholland H, Babcock K, Montori VM, Jones A. Documentation of Psychosocial Distress and Its Antecedents in Children with Rare or Life-Limiting Chronic Conditions. Children (Basel). 2022 May 5;9(5):664. doi: 10.3390/children9050664.
World Health Organization Group Problem Management Plus (Group PM+): group psychological help for adults impaired by distress in communities exposed to adversity. Generic field-trial version 1.0. 30 August 2020. https://www.who.int/publications/i/item/9789240008106
Jordans MJD, Kohrt BA, Sangraula M, Turner EL, Wang X, Shrestha P, Ghimire R, Van't Hof E, Bryant RA, Dawson KS, Marahatta K, Luitel NP, van Ommeren M. Effectiveness of Group Problem Management Plus, a brief psychological intervention for adults affected by humanitarian disasters in Nepal: A cluster randomized controlled trial. PLoS Med. 2021 Jun 17;18(6):e1003621. doi: 10.1371/journal.pmed.1003621. eCollection 2021 Jun.
de Graaff AM, Cuijpers P, Twisk JWR, Kieft B, Hunaidy S, Elsawy M, Gorgis N, Bouman TK, Lommen MJJ, Acarturk C, Bryant R, Burchert S, Dawson KS, Fuhr DC, Hansen P, Jordans M, Knaevelsrud C, McDaid D, Morina N, Moergeli H, Park AL, Roberts B, Ventevogel P, Wiedemann N, Woodward A, Sijbrandij M; STRENGTHS Consortium; STRENGTHS consortium. Peer-provided psychological intervention for Syrian refugees: results of a randomised controlled trial on the effectiveness of Problem Management Plus. BMJ Ment Health. 2023 Feb;26(1):e300637. doi: 10.1136/bmjment-2022-300637. Epub 2023 Feb 8.
Weathers et al., The PTSD Checklist for DSM-5 (PCL-5) - Standard [Measurement instrument]. https://www.ptsd.va.gov
Czachowski S, Seed P, Schofield P, Ashworth M. Measuring psychological change during cognitive behaviour therapy in primary care: a Polish study using 'PSYCHLOPS' (Psychological Outcome Profiles). PLoS One. 2011;6(12):e27378. doi: 10.1371/journal.pone.0027378. Epub 2011 Dec 15.
Ustun, et al. and World Health Organization. Measuring health and disability: manual for WHO Disability Assessment Schedule (WHODAS 2.0). World Health Organization 2010. Manual 16, June 2016.
Ali AM, Schwalk DE, Lyon ME. Adapting and Beta Testing Rare Group Problem Management Plus for Family Caregivers of Children with Rare Diseases. (April 30, 2025). Poster. 2025 Awardee Medical Student Research Day, Abdulla Ali, in the category of Clinical and Translational Research. George Washington University School of Medicine and Health Sciences, Washington DC.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRBear Protocol # 1049
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.