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Parenting Matters: Helping Parents With Young Children

11. april 2018 oppdatert av: University of Western Ontario, Canada
Sleep and discipline problems are the most common problems for parents of young children (ages 2 to 5 years old) and are the two concerns with the strongest relations to future child behavior problems. The Parenting Matters program combines treatment booklets and telephone support to help parents deal with sleep or discipline problems. Parents with concerns and who are interested in the study are identified during a visit to their family physician. We, the investigators at the University of Western Ontario, expect that parents receiving treatment booklets, along with usual care by their family physician, will have greater reductions in their child's sleep or discipline problems, improved parenting practices, and greater reductions in child behaviour problems after receiving the Parenting Matters intervention, compared to parents receiving usual medical care.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

About 1 in 5 young children (ages 2 to 5 years) has a significant psychosocial problem, but over 80% do not receive treatment. Without treatment, up to half of these children will have problems into childhood and adolescence. New methods of treating and preventing children's psychosocial problems are needed.

Sleep and discipline problems (or child non-compliance) are the most common problems for parents of young children, and are the two concerns with the strongest relations to future child behavior problems. Further, parenting practices have consistently been linked to the development of psychosocial problems. The Parenting Matters program combines treatment booklets and telephone support to help parents with sleep or discipline problems among young children.

Objectives:

  • Test the efficacy of the Parenting Matters program interventions for sleeping and bedtime behaviors (Trial 1), and discipline (Trial 2) in reducing problem-specific outcomes.
  • Test the effects of the Parenting Matters program interventions for parents who are concerned about both their children's sleep and discipline (Trial 3) in reducing problem-specific outcomes related to sleep (Group 1) and discipline problems (Group 2) will be tested.
  • Test the efficacy of the Parenting Matters program in improving parenting practices.
  • Test the efficacy of the Parenting Matters program in reducing child behaviour problems in general.
  • Examine predictors of treatment success.

Method:

All parents of 2 to 5 year-olds seen in a family practice for a routine appointment are asked to complete a psychosocial concerns checklist. Parents who have concerns regarding their child's sleep (Trial 1), how to discipline their child (Trial 2), or concerns about both their child's sleep and discipline (Trial 3), and meet the other study criteria, are invited to take part in the study. Mailed baseline assessment packages assess children's behavior, parenting practices and potential predictors of treatment success.

Parents are randomized to usual care, or the Parenting Matters program along with usual care. The Parenting Matters program includes treatment booklets addressing either sleep or discipline problems, and telephone coach support (3 calls over 6 weeks).

Primary outcomes are parents' ratings of their children's sleep or discipline problems measured at post-treatment (7 weeks after baseline). Parents repeat assessment packages at 3- and 6-month follow-ups.

Goals & Relevance:

This research addresses the need for new ways of providing early interventions for young children that:

  • reach the largest number of individuals in need;
  • are cost effective; and
  • time efficient.

By addressing the most common issues facing parents of young children, it engages parents in areas of direct relevance to them. The program focuses on parenting practices thereby building family strengths that may have a lasting impact on child development. Collaboration with family physicians builds on the ongoing positive relationships between parents and family physicians and provides a mechanism to reach a significant proportion of young children.

Studietype

Intervensjonell

Registrering (Faktiske)

548

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • Ontario
      • London, Ontario, Canada, N6C 5A2
        • University of Western Ontario

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

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Parent (primary caregiver) of a 2-5 year old child
  • Attending a medical appointment at a family medical practice
  • Phone in home
  • Parent concerned about child's sleep and/or discipline
  • Parent interested in participating in a treatment study

Exclusion Criteria:

  • Parent non-English speaking
  • Child with significant physical or developmental disability
  • Parent's only sleep concern is in regards to a physiological sleep disorder (e.g. sleep apnea, snoring) or bedwetting
  • No phone

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

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

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Vanlig omsorg
Atferdsmessig: Usual care by a family physician
Parents in the usual care condition were told to continue with care from their family physician and/or any other treatment recommended by the physician.
Eksperimentell: Treatment booklet and telephone coaching
Atferdsmessig: Self-help treatment booklet and telephone support
The Parenting Matters treatment program consisted of a self-help treatment booklet and two telephone coaching calls from a paraprofessional telephone coach at Weeks 2 and 5 of the program. Two booklets were used in the three trials; one addressed sleep issues and the second discipline problems.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Sleep and bedtime problems trial (Trial 1): parent report on the Children's Sleep Habits Questionnaire
Tidsramme: 7 weeks post randomization
7 weeks post randomization
Discipline problems trial (Trial 2): parent rated total problem score on the Eyberg Child Behavior Inventory
Tidsramme: 7 weeks post randomization
7 weeks post randomization
Sleep and discipline problems trial (Trial 3): parent report on the Children's Sleep Habit Questionnaire (Group 1-sleep treatment) and parent rated total problem score on the Eyberg Child Behavior Inventory (Group 2-discipline treatment)
Tidsramme: 7 weeks post randomization
7 weeks post randomization

Sekundære resultatmål

Resultatmål
Tidsramme
Parenting practices-total score on the Parenting Scale
Tidsramme: 7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
General child behavior problems-total problem score on the Child Behavior Checklist
Tidsramme: 7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Daily recall ratings of sleep and discipline problems (3 reports in total)
Tidsramme: 4 & 6 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
4 & 6 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Parent report on the Richman sleep questionnaires (only for Trial 1-sleep and bedtime problems and for Trial 3 participants if in sleep treatment condition)
Tidsramme: 7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only

Samarbeidspartnere og etterforskere

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

Sponsor

University of Western Ontario, Canada

Samarbeidspartnere

Canadian Institutes of Health Research (CIHR)
Children's Hospital of Eastern Ontario

Etterforskere

  • Hovedetterforsker: Graham J Reid, PhD, Western University, Canada

Publikasjoner og nyttige lenker

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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

1. juli 2005

Primær fullføring (Faktiske)

1. mars 2009

Studiet fullført (Faktiske)

1. mars 2009

Datoer for studieregistrering

Først innsendt

18. august 2005

Først innsendt som oppfylte QC-kriteriene

18. august 2005

Først lagt ut (Anslag)

22. august 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. april 2018

Sist bekreftet

1. august 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 67816; 280205-014
  • ISRCTN81511074

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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