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Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)

29 października 2026 zaktualizowane przez: Yale University

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.

Przegląd badań

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

110

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • Connecticut
      • New Haven, Connecticut, Stany Zjednoczone, 06519
        • Yale Child Study Center
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

6 lat do 12 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.

Aktywny komparator: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Pica, ARFID, and Rumination Disorder Interview (PARDI-C/P)
Ramy czasowe: 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
Nine-Item Avoidant/Restrictive Food Intake Disorder Screen - Parent and Child Report (NIAS-C/P)
Ramy czasowe: 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
Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I)
Ramy czasowe: Weeks 1 and 16-20

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Children's Food Neophobia Scale - six item version (CFNS-6)
Ramy czasowe: 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
Caregiver Strain Questionnaire (CGSQ)
Ramy czasowe: 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
Parent-Rated Food Flexibility Scale (FFS)
Ramy czasowe: Weeks 1, 8-10, 16-20 and 6 months later

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
Acceptance and Confidence Scale - Anxiety
Ramy czasowe: Weeks 1, 8-10, 16-20 and 6 months later

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
Weekly Food Update
Ramy czasowe: Weeks 1-20

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
Parent-completed Glasgow Sensory Questionnaire, short form (rGSQ-P)
Ramy czasowe: Weeks 1, 8-10, 16-20 and 6 months later

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
Client Satisfaction Questionnaire (CSQ-8)
Ramy czasowe: Week 16-20

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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Family Accommodation Scale - Anxiety (FASA-C/P)
Ramy czasowe: Weeks 1 and 16-20

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
Family Assessment Device - General Functioning Scale (FAD-GF)
Ramy czasowe: Weeks 1 and 16-20

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Eli Lebowitz, Yale University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 grudnia 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2030

Ukończenie studiów (Szacowany)

1 grudnia 2030

Daty rejestracji na studia

Pierwszy przesłany

29 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 października 2026

Pierwszy wysłany (Rzeczywisty)

4 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 października 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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