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A Pilot Intervention With Families of Children With Special Health Care Needs

10 sierpnia 2018 zaktualizowane przez: Caroline Kistin, Boston Medical Center

A Theory-Based Intervention to Prevent Child Neglect in High-Risk

This is a pilot randomized controlled trial of a behavioral intervention focused on improving parenting skills and preventing child neglect in families of children with special health care needs. The intervention focuses on problem solving, distress tolerance, and emotional regulation skills.

Przegląd badań

Status

Wycofane

Warunki

Interwencja / Leczenie

Szczegółowy opis

This pilot randomized controlled trial will be conducted with 60 caregivers of children with special health care needs who have been reported to the child protection team at Boston Medical Center with concern for neglect that was ultimately not substantiated. Half of the subjects will be randomly assigned to receive the 6-session, one-on-one, in-person, behavioral intervention focused on problem solving, emotional regulation, and distress tolerance. The other half will be randomly assigned to the control group and will receive periodic check-ins and referrals to community resources as needed. Both groups will be followed for 12 months after randomization.

Children who have previously experienced neglect, or other forms of maltreatment, will not included in the study. Children will be defined as having special health care needs if they have a chronic physical, emotional, or behavioral condition.

With this pilot, the investigators aim to field-test study mechanics, including enrollment, randomization, and the collection of baseline and follow-up data; and obtain empiric estimates of study parameters to inform a subsequent fully-powered randomized controlled trial.

Typ studiów

Interwencyjne

Faza

  • Nie dotyczy

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Stany Zjednoczone
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02118
        • Boston Medical Center

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

16 lat i starsze (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Primary caregiver of a child under age 7 with a special health care need, defined as a chronic physical, emotional, or behavioral health condition
  • Child has been referred to the Child Protection Team for neglect that was ultimately not substantiated
  • Fluent in English or Spanish

Exclusion Criteria:

  • Prior history of substantiated child maltreatment

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: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Intervention

The intervention group will receive a one-on-one in-person intervention of 6 sessions, each lasting approximately 60 minutes. The intervention is intended to be delivered over a period of 12 weeks, with sessions occurring every 1-2 weeks. The overview of the 6 sessions is as follows:

  1. Behavioral chain analysis of episodes where parent felt stressed and episode where things went well. Identification of sources of interpersonal support.
  2. Stress relief. Development of a detailed crisis plan.
  3. Problem solving techniques.
  4. Emotional regulation exercises.
  5. Positive parenting, review of parenting challenges.
  6. Reflection, repeat behavioral chain analysis. Update crisis plan.
Behawioralne: Intervention

The intervention group will receive a 6-session intervention. The overview of the 6 sessions is as follows:

  1. "Behavioral chain analysis" of episode where parent felt stressed with child and episode where things went well. Identification of sources of interpersonal support.
  2. Stress relief techniques. Identification of short and long-term goals. Development of a detailed crisis plan.
  3. Problem solving techniques.
  4. Emotional regulation. Exercises to identify moods and explore connections between feelings, thoughts, and behavior.
  5. Positive parenting, review of common and specific parenting challenges, child development, short and long-term effects of different discipline approaches.
  6. Reflection, repeat behavioral chain analysis. Update crisis plan.
Aktywny komparator: Control
The families in the control group will be contacted by a member of the study team 6 times in 12 weeks to approximate the frequency of contact that the intervention group receives. The study team member will check in with families on the telephone or in person and will help them connect with clinic and community resources as needed.
Inny: Control
The families in the control group will be contacted by a member of the study team 6 times in 12 weeks to approximate the frequency of contact that the intervention group receives. The study team member will check in with families on the telephone or in person and will help them connect with clinic and community resources as needed.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Study Logistics - subject enrollment
Ramy czasowe: Monthly change from baseline to 12 months post randomization
As this is a pilot study, the primary objective is to field test study logistics, including subject enrollment. The investigators will review monthly counts of enrolled subjects from baseline to 12 months post-randomization, and will compare the number of subjects in each study arm to target enrollment goals. Because of emerging consensus that group-to-group comparisons in a pilot study are not only invalid but also misleading, estimating effect size is deliberately not our primary study objective.
Monthly change from baseline to 12 months post randomization
Study Logistics - fidelity of intervention delivery
Ramy czasowe: 3 months post randomization
For the intervention group, treatment fidelity will be assessed by audio taping a random 10% of sessions and scoring them with standardized instruments. The investigators will measure the proportion of sessions delivered with fidelity. Because of emerging consensus that group-to-group comparisons in a pilot study are not only invalid but also misleading, estimating effect size is deliberately not our primary study objective.
3 months post randomization

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Re-referral to child protection team or social services
Ramy czasowe: 3 months post randomization
The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 3 months post randomization. This will allow the investigators to power a later study for this dichotomous outcome.
3 months post randomization
Re-referral to child protection team or social services
Ramy czasowe: 6 months post randomization
The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 6 months post randomization. This will allow the investigators to power a later study for this dichotomous outcome.
6 months post randomization
Re-referral to child protection team or social services
Ramy czasowe: 12 months post randomization
The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 12 months post randomization. This will allow the investigators to power a later study for this dichotomous outcome.
12 months post randomization
Adherence to recommended medical care
Ramy czasowe: 3 months post randomization
The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis. The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.
3 months post randomization
Adherence to recommended medical care
Ramy czasowe: 6 months post randomization
The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis. The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.
6 months post randomization
Adherence to recommended medical care
Ramy czasowe: 12 months post randomization
The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis. The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.
12 months post randomization

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Parental well-being and mental health - Quick Inventory of Depressive Symptomatology
Ramy czasowe: Change in score from baseline to 12 months post randomization
The investigators will use validated measures to evaluate parental well-being. The measures include the Quick Inventory of Depressive Symptomatology. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (depression present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
Change in score from baseline to 12 months post randomization
Parental well-being and mental health - the Social Adjustment Scale-Short Report
Ramy czasowe: Change in score from baseline to 12 months post randomization
The investigators will use validated measures to evaluate parental well-being. The measures include the Social Adjustment Scale-Short Report. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (social adjustment present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
Change in score from baseline to 12 months post randomization
Parental well-being and mental health - the Medical Outcomes Survey Social Support
Ramy czasowe: Change in score from baseline to 12 months post randomization
The investigators will use validated measures to evaluate parental well-being. The measures include the Medical Outcomes Survey Social Support. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (social support present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
Change in score from baseline to 12 months post randomization
Parental well-being and mental health - the Perceived Stress Scale
Ramy czasowe: Change in score from baseline to 12 months post randomization
The investigators will use validated measures to evaluate parental well-being. The measures include the Perceived Stress Scale. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (stress present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
Change in score from baseline to 12 months post randomization
Parental well-being and mental health - the Parenting Stress-Short Form
Ramy czasowe: Change in score from baseline to 12 months post randomization
The investigators will use validated measures to evaluate parental well-being. The measures include the Parenting Stress-Short Form. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (parenting stress present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
Change in score from baseline to 12 months post randomization
Parental well-being and mental health - the Parenting Scale
Ramy czasowe: Change in score from baseline to 12 months post randomization
The investigators will use validated measures to evaluate parental well-being. The measures include the Parenting Scale. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (parenting style present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
Change in score from baseline to 12 months post randomization
Parental well-being and mental health - the Parent Development Interview-Revised
Ramy czasowe: Change in score from baseline to 12 months post randomization
The investigators will use validated measures to evaluate parental well-being. The measures include the Parent Development Interview-Revised. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (reflective functioning present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
Change in score from baseline to 12 months post randomization

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Boston Medical Center

Współpracownicy

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Śledczy

  • Główny śledczy: Caroline J Kistin, MD, MSc, Boston University School of Medicine/Boston Medical Center

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 (Rzeczywisty)

1 sierpnia 2017

Zakończenie podstawowe (Oczekiwany)

1 sierpnia 2018

Ukończenie studiów (Oczekiwany)

1 sierpnia 2018

Daty rejestracji na studia

Pierwszy przesłany

5 kwietnia 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 kwietnia 2016

Pierwszy wysłany (Oszacować)

19 kwietnia 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 sierpnia 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 sierpnia 2018

Ostatnia weryfikacja

1 sierpnia 2018

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • H-35105
  • 1K23HD078503-01A1 (Grant/umowa NIH USA)

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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