- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07916974
Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
This study aims to test the efficacy of a parent-based approach to treating Avoidant/Restrictive Food Intake Disorder (ARFID) in children, SPACE-ARFID (Supportive Parenting for Anxious Childhood Emotions, adapted for ARFID), by comparing it to Nutritional Support (NS). The study design is a randomized controlled trial with 2 treatment arms and 3 assessment points (pre, post, and follow-up) using questionnaire data and clinical interviews.
Přehled studie
Postavení
Detailní popis
The primary objective is to examine if SPACE-ARFID is more efficacious than NS in reducing adolescent ARFID symptoms. The secondary objective is to examine if SPACE-ARFID produces greater change than NS in improving family accommodation and family functioning. SPACE and NS will be delivered over 16-20 weekly sessions, pre-assessment will take place before sessions begin and post-assessment will take place once sessions end, there will also be a midpoint assessment halfway through treatment (sessions 8-10) and one more follow-up assessment 6 months later.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Alison Magnotti, MA
- Telefonní číslo: 203-737-4644
- E-mail: alison.magnotti@yale.edu
Studijní záloha kontaktů
- Jméno: Eli Lebowitz, PhD
- Telefonní číslo: 203-737-4644
- E-mail: eli.lebowitz@yale.edu
Studijní místa
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Connecticut
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New Haven, Connecticut, Spojené státy, 06519
- Yale Child Study Center
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Kontakt:
- Eli Lebowitz, PhD
- Telefonní číslo: 203-737-4644
- E-mail: eli.lebowitz@yale.edu
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Be between 6 and 12 years old.
- Meet DSM-5 diagnostic criteria for ARFID, as determined by the PARDI diagnostic interview.
- Cease all other psychotherapeutic treatment targeting eating or feeding behaviors, upon consultation with project staff and the current service provider.
- Not currently use any psychotropic medication, unless on a stable dose for a minimum of 4 weeks prior to enrollment; no changes anticipated during the course of the study.
- BMI at or above the 5th percentile for age and sex.
- Have an eligible and willing participating parent (see parent exclusions below).
Exclusion Criteria:
Adolescents:
- Meet criteria for any other DSM-5 disorder as determined by the ADIS diagnostic interview and health history form, that is sufficiently impairing or disruptive so as to make treatment focused on ARFID not feasible.
- Have any of the following disorders: intellectual disability; bipolar disorder; schizophrenia and other psychotic disorders; and alcohol and substance use disorders, as determined by the health history form.
- Report a suicide attempt in the last 3 months, or current suicide intent and/or plans.
- Be a victim of past or present undisclosed abuse requiring investigation or ongoing supervision by the Department of Children and Families.
- Not have sufficient proficiency in English to complete assessments.
- Require a level of medical care for nutritional compromise that exceeds what can be safely provided in an outpatient setting.
Parents:
- Have any of the following: intellectual disability; untreated bipolar disorder; untreated schizophrenia and other psychotic disorders; and untreated alcohol and substance use disorders, report a suicide attempt in the last 3 months, or current suicide intent and/or plans.
- Not be living with the child at least 50% of the time.
- Not have sufficient proficiency in English to complete assessments and participate in treatment.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Supportive Parenting for Anxious Childhood Emotions (SPACE)
Parent-only approach to treating anxiety disorders in adolescents delivered over 16-20 sessions. |
Parent-based treatment delivered by therapist for 16-20 weekly sessions. |
|
Aktivní komparátor: Nutritional Support (NS)
Parent-only approach comparator arm delivered over 16-20 sessions. |
Nutritional Support from Registered Dietician for 16-20 weekly sessions with parents. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pica, ARFID, and Rumination Disorder Interview (PARDI-C/P)
Časové okno: Weeks 1 and 16-20
|
This semi-structured clinical interview will assess ARFID presence and severity. Symptoms are rated on a 0 (no symptoms) to 6 (severe symptoms) scale. It yields an overall severity score and three profile scores (sensory sensitivity, lack of interest in eating or food, fear of aversive consequences). Score range = 0 to 6 with higher scores indicating greater severity. |
Weeks 1 and 16-20
|
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Nine-Item Avoidant/Restrictive Food Intake Disorder Screen - Parent and Child Report (NIAS-C/P)
Časové okno: Weeks 1, 8-10, 16-20 and 6 months later
|
This measure is a screener of ARFID severity. It contains 9 items, each rated on a 6-point scale from 0 ("strongly disagree") to 5 ("strongly agree"). It yields a total score and three subscale scores (picky/selective eating, poor appetite/limited interest, fear of negative consequences). Total score range = 0 to 45, with higher scores indicating greater severity. |
Weeks 1, 8-10, 16-20 and 6 months later
|
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Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I)
Časové okno: Weeks 1 and 16-20
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This measure will be used to assess overall severity (CGI-S) and improvement (CGI-I) in adolescent ARFID. Total score range for each is 1-7. (Scores of 1 ("very much improved/normal") or 2 ("much improved/borderline ill") indicate a positive treatment response; all other responses are considered negative responses. Higher scores indicate worse outcome. |
Weeks 1 and 16-20
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Children's Food Neophobia Scale - six item version (CFNS-6)
Časové okno: Weeks 1, 8-10, 16-20 and 6 months later
|
This measure of children's reluctance to try new or unfamiliar foods contains 6 items rated on a 4-point scale from 1 ("strongly disagree") to 4 ("strongly agree"), with 2 items reverse-scored. Total score range = 1 to 24, with higher scores indicating greater food neophobia. |
Weeks 1, 8-10, 16-20 and 6 months later
|
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Caregiver Strain Questionnaire (CGSQ)
Časové okno: Weeks 1, 8-10, 16-20 and 6 months later
|
This scale will measure the strain caregivers experience as a result of their child's emotional and behavioral problems. It contains 21 items, each rated on a 5-point scale from 1 ("not at all a problem") to 5 ("very much a problem") for how much each occurrence or feeling was a problem in the past 6 months. The items form three subscales: objective strain (11 items), subjective internalized strain (6 items), and subjective externalized strain (4 items). Subscale and global scores are item means, 1 item ("relating well to child") is reverse scored. Scores range = 1 to 5, with higher scores indicating greater strain. |
Weeks 1, 8-10, 16-20 and 6 months later
|
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Parent-Rated Food Flexibility Scale (FFS)
Časové okno: Weeks 1, 8-10, 16-20 and 6 months later
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This scale is a 10-item parent-report measure of the child's tolerance of variability across food-related domains. Parents rate each domain on a 5-point scale from 0 ("very inflexible") to 4 ("very flexible"), with "mostly inflexible" (1), "some flexibility" (2), and "mostly flexible" (3) in between. Ratings are summed to a total score (range = 0 to 40), with higher scores indicating greater flexibility. |
Weeks 1, 8-10, 16-20 and 6 months later
|
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Acceptance and Confidence Scale - Anxiety
Časové okno: Weeks 1, 8-10, 16-20 and 6 months later
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This scale is a measure of the extent to which parents express acceptance of and confidence in the face of their child's anxiety, a key clinical target of SPACE. It contains 8 items, each rated on a 6-point scale from 1 ("strongly disagree") to 6 ("strongly agree"). Total score range = 8 to 48, with higher scores indicating greater acceptance and confidence. |
Weeks 1, 8-10, 16-20 and 6 months later
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Weekly Food Update
Časové okno: Weeks 1-20
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This brief questionnaire tracks changes in the child's eating over the course of treatment. Parents complete it before each weekly session, thinking back over the past week. The form has two parts. In the first, parents indicate whether their child ate each food already being tracked, and if so, how much (a taste, some, or a full portion), and whether the child now eats it regularly. In the second, parents record foods that are new that week: foods the child has never eaten before, foods the child is eating again after a long period of avoidance, and familiar foods eaten in a new way (for example, a different brand, preparation, or setting). |
Weeks 1-20
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Parent-completed Glasgow Sensory Questionnaire, short form (rGSQ-P)
Časové okno: Weeks 1, 8-10, 16-20 and 6 months later
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This scale has 24 items and measures children's sensory hyper- and hypo-sensitivity across six sense domains (visual, auditory, gustatory, olfactory, tactile, vestibular). Parents rate items on a 5-point scale from 0 ("never") to 4 ("always"), yielding total (0-96), hyper-sensitivity (0-48), and hypo-sensitivity (0-48) scores, with higher scores indicating greater sensory sensitivity. |
Weeks 1, 8-10, 16-20 and 6 months later
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Client Satisfaction Questionnaire (CSQ-8)
Časové okno: Week 16-20
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This 8-item measure assesses client satisfaction. Parents and adolescents rate items on a 0-4 scale, with higher summed scores indicating greater satisfaction with services (range = 0 to 32). |
Week 16-20
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Family Accommodation Scale - Anxiety (FASA-C/P)
Časové okno: Weeks 1 and 16-20
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This scale is a widely used measure of family accommodation. Adolescents and parents rate 9 items on a 5-point scale from 0 ("never") to 4 ("daily"). Total score range = 0 to 36. |
Weeks 1 and 16-20
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Family Assessment Device - General Functioning Scale (FAD-GF)
Časové okno: Weeks 1 and 16-20
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This scale measures overall family functioning. Adolescents and parents rate 12-items on a 4-point scale from 0 ("strongly disagree") to 3 ("strongly agree"). Total score range = 0 to 36. |
Weeks 1 and 16-20
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Eli Lebowitz, Yale University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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