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Идёт набор NCT06650267

Substance Misuse and Family Violence Treatment Fathers

Фаза II С лечением Substance Misuse Violence, Domestic Child Abuse

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Fathers for Change (F4C), Individual Drug Counseling (IDC).
Кому может быть актуально
Состояния в реестре: Substance Misuse, Violence, Domestic, Child Abuse. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Substance Misuse and Family Violence Treatment for Fathers

Обзор

This study involves a randomized controlled trial of Fathers for Change (F4C) compared to Individual Drug Counseling (IDC) with a sample of 280 fathers enrolled in substance use (SU) treatment within community or veterans (VA) healthcare settings to (a) demonstrate F4C efficacy compared to IDC in reducing SU and family violence (FV) at end of treatment, 3- and 6-month post-treatment follow-up, and (b) document improved emotion regulation as the mechanism within F4C that results in reduced SU and FV.

Вмешательства

  • Поведенческое Fathers for Change (F4C)
    Defining features of F4C delivered over 18 sessions: 1) focus on the fathers model of fatherhood as a motivator for change, 2) focus on understanding and identifying feelings, teaching skills to identify and change emotional dysregulation that lead to both SU and FV, 3) co-parent communication skills to reduce stress and improve problem solving, 4) restorative parenting (see Table 1 and figure 1)127. F4C focuses on reflective understanding of emotional experiences, how that impacts thoughts and
  • Поведенческое Individual Drug Counseling (IDC)
    IDC is an individual evidence-based SU treatment84 that incorporates two elements: endorsement of the disease model and the spiritual dimensions of recovery. These elements differentiate the approach from F4C. IDC is influenced by 12-step recovery philosophy and participation in 12-step groups like NA are encouraged. The model places focus on the individual in recovery without a focus on fatherhood or co-parenting. IDC will be offered in an 18-session format.

Первичные конечные точки

  • Substance Misuse [Срок оценки: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45]
  • Family Violence (FV) [Срок оценки: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45]
Вторичные конечные точки (2)
  • Emotion Dysregulation [Срок оценки: Baseline (week 0), Post-Treatment at week 19, week 32 and week 45]
  • Articulated Thoughts in Simulated Situations (ATSS) [Срок оценки: Baseline (week 0) and Post-Treatment (week 18)]

Критерии участия

Критерии включения

  • meet DSM-5 criteria for an SU disorder at the time of assessment at APT or VACHS;
  • report FV within the last 18 months prior to screening (based on self, court, police or child protection reports);
  • have at least one biological child aged 1 to 12 years with whom they live or have at least twice per month in person visits;
  • are able to complete assessments in English; and
  • agree to have their female coparents (mother of the youngest child) contacted for participation of their youngest child. If a participant has more than one child in the age range, the youngest will be the target of assessment and treatment.

Критерии исключения

  • an active full/no contact protective order pertaining to their child;
  • physiological addiction to a substance that requires detoxification (such individuals may be re-evaluated following detox);
  • cognitive impairment (a mini mental state score <25);
  • current untreated psychotic/bipolar disorder;
  • currently suicidal or homicidal based on Brief Symptom Inventory Screening and follow-up on positive responses; or
  • are currently receiving weekly individual therapy for Substance misuse or family violence

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Yale University Child Study Center — New Haven
  • APT Foundation — West Haven

Идентификаторы

NCT: NCT06650267 · 2000038147 · 1R01DA059914-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗