- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07743645
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Developing Biomarker-Supported SSD Prevention
The purpose of this study is to compare the effect of a brief family-based psychosocial intervention that addresses modifiable SSD risk factors on persistent and distressing psychotic-like experiences in children and young adults with a family history of SSD and high versus low baseline SSD-like brain patterns
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yizhou Ma, PhD
- Numéro de téléphone: 713-486-2740
- E-mail: Yizhou.Ma@uth.tmc.edu
Sauvegarde des contacts de l'étude
- Nom: Oluwabunmi Akindona, BA
- Numéro de téléphone: 713-486-2740
- E-mail: Oluwabunmi.Akindona@uth.tmc.edu
Lieux d'étude
-
-
Texas
-
Houston, Texas, États-Unis, 77030
- Recrutement
- The University of Texas Health Science Center at Houston
-
Contact:
- Yizhou Ma, PhD
- Numéro de téléphone: 713-486-2740
- E-mail: Yizhou.Ma@uth.tmc.edu
-
Contact:
- Oluwabunmi Akindona, BA
- Numéro de téléphone: 713-486-2740
- E-mail: L.Elliot.Hong@uth.tmc.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Family history of SSD (defined as first-degree (e.g., a parent or a sibling), second-degree (e.g., an uncle or a grandparent), or other combinations of biological relatives in the family have or likely have a diagnosis of SSD or other closely related severe mental illnesses equivalent to at least 25% of genetic sharing) per medical record review and/or parent/legal guardian/self report and confirmed by a structured interview;
- screening positive for two or more risk factors targeted by the intervention;
- aged ≥ 9 and <26 years of birthday;
- Participants and parent(s)/legal guardian(s)/other family member(s) agree to participate;
- psychiatrically stable and have no major changes in antidepressant, stimulant, or antipsychotic medication in the past 4 weeks.
Exclusion Criteria:
- Current or past history of psychotic disorders or clinical high risk for psychosis (CHR-p) per study interview;
- Current or past antipsychotic medication use to specifically treat a psychotic disorder;
- major medical and neurological conditions;
- moderate to severe intellectual disabilities or mild intellectual disabilities but expected to have difficulty completing the study assessments;
- current drug or alcohol use that impacts functioning and study engagement;
- Not able to give assent, permission, or consent;
- Not able to undergo MRI.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Psychosocial intervention group
|
Over 16 weeks, participants and their parent(s)/legal guardian(s)/other family member(s) will attend weekly hour long family-based psychosocial intervention to work on their top 2 modifiable SSD-risk factors targeted by the risk reduction therapy (RRT) |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in persistent distressing psychotic-like experiences as assessed by a modified Prodromal Questionnaire Brief-Child Version (PQ-BC) questionnaire
Délai: Baseline, 8 weeks, end of intervention (16 weeks after baseline ), 1-year follow up
|
This is a 21 item questionnaire and items are scored as 0 (symptom not endorsed) or 1 (symptom endorsed). Items endorsed are further assessed for level of distress (1-5) and chronicity (present 6 months, 1 year, 2 years, or more than 2 years ago). The total symptom score is calculated as the sum of distress ratings of all items at baseline with 1) "Did it bother you?" answered "Y" AND 2) endorsed as distressing at one or more previous time points. The range of the total symptom score is 0 to 105. Higher scores indicate greater distressing and persistent psychotic-like experiences. |
Baseline, 8 weeks, end of intervention (16 weeks after baseline ), 1-year follow up
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery
Délai: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
|
Change in Cognitive Function as assessed by the NIH Toolbox Cognitive Test Battery (List Sorting Working Memory and Pattern Comparison Processing Speed subtests) and the Rey Auditory Verbal Learning test (RAVLT). Measured at baseline, end-of-intervention (16 weeks after baseline), and 1-year follow-up. Higher scores indicate better cognitive performance. For NIH Tooolbox, raw scores of the test taker are compared to the scores in the NIH Toolbox nationally representative normative sample to derive standard scores. The mean standard score is 100 and the standard deviation (SD) is 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment. For the RAVLT, raw scores will be used. |
Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
|
|
Change in psychopathology measured by the Child or Adult Behavior Checklist (CBCL or ABCL)
Délai: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
|
CBCL and ABCL are questionnaires containing ~120 items and each problem item is scored as: 0 (not true) 1(somewhat or sometimes true) and 2 (very true or often true). Raw scores are summed and converted to age- and sex-normed T-scores. Higher T-scores indicate greater overall psychopathology. Scores between 50 and 64 are within the normal range. Scores between 65 and 69 are within the borderline range. Scores above 70 are within the clinical range. |
Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
|
|
Change in stress level measured by the Perceived Stress Scale (PSS)
Délai: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
|
This is a 10 item questionnaire and each item is scored on a 5-point scale from 0(never) to 4 (very often). Positively worded items are reverse scored, and all items are summed to generate a total score ranging from 0 to 40. Higher scores indicate greater perceived stress. |
Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Yizhou Ma, PhD, The University of Texas Health Science Center, Houston
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- HSC-MS-25-0001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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