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

10. august 2018 oppdatert av: 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.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Boston Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Aktiv 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Study Logistics - subject enrollment
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Re-referral to child protection team or social services
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Parental well-being and mental health - Quick Inventory of Depressive Symptomatology
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boston Medical Center

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2017

Primær fullføring (Forventet)

1. august 2018

Studiet fullført (Forventet)

1. august 2018

Datoer for studieregistrering

Først innsendt

5. april 2016

Først innsendt som oppfylte QC-kriteriene

14. april 2016

Først lagt ut (Anslag)

19. april 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • H-35105
  • 1K23HD078503-01A1 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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