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Completed

NCT Number: NCT00392847

Promoting Parental Skills and Enhancing Attachment in Early Childhood

Child psychological/behavioural disorders such as withdrawal may persist when the psychosocial context is unfavourable. Health promotion strategies (Olds' paradigm) have proved their efficacy in vulnerable populations. CAPEDP project sets out to evaluate a program of home visits in France

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Key information

Conditions

Behavioral Disorders Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Neurodevelopmental Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

Up to 26 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bichat-Claude Bernard Hospital

Paris, 75018, France

About this study

This program aims at reducing psychosocial disorders and promoting mental health, social support and attachment amongst at-risk young women and their family. 440 primigravida (pregnant women) will be randomised into two groups. The first group will receive routine follow-up as currently provided by national community health and social services. The second group will receive home visits by community workers. These visits will start during pregnancy and will continue up to the child's second birthday.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being less than 26 years old
  • Being pregnant for less than 27 weeks
  • Being primiparous
  • Living in the study area
  • Being socially vulnerable: less than 12 years of education AND/OR socially isolated AND/OR eligible for a public health insurance for people with low resources.

Exclusion criteria

  • Refusal to participate
  • Not able to speak French
  • Having a medical follow-up which necessitates regular contact with health professional
  • Not having health insurance
  • Persons for whom follow up at 27 months is impossible (evaluation at baseline)

Treatment and study plan

Promoting Parental Skills and Enhancing Attachment

Behavioral

The first group will receive routine follow-up as currently provided by national community health and social services.

had home visits by community workers during pregnancy

Behavioral

had home visits by community workers during pregnancy to the child's second birthday.

Other names: to the child's second birthday.

Primary outcomes

  1. Mothers' scores on a postnatal depression scale (baseline, and when the child is 3, 6 and 12 months old)

    Time frame: baseline, and when the child is 3, 6 and 12 months old

  2. Parental competencies (when the child is 3, 12 and 18 months old)

    Time frame: when the child is 3, 12 and 18 months old

  3. Child mental health (when the child is 18 and 24 months old)

    Time frame: when the child is 18 and 24 months old

Secondary outcomes

  1. Child attachment (when the child is 18 months old)

    Time frame: when the child is 18 months old

  2. Family use of medical and social services (baseline, and when the child is 3, 6, 12 and 24 months old)

    Time frame: baseline, and when the child is 3, 6, 12 and 24 months old

  3. Family social support (baseline, and when the child is 3, 12 and 24 months old)

    Time frame: baseline, and when the child is 3, 12 and 24 months old

  4. Mother's self-esteem as a parent (when the child is 3, 12 and 24 months old)

    Time frame: when the child is 3, 12 and 24 months old

  5. Child psychomotor development (when the child is 6, 12 and 24 months old)

    Time frame: when the child is 6, 12 and 24 months old

  6. Mother's knowledge about child development (baseline, and when the child is 3 and 24 months old)

    Time frame: baseline, and when the child is 3 and 24 months old

  7. Mother's attachment (at baseline)

    Time frame: at baseline

  8. Mother's mental health (baseline, and when the child is 3 and 24 months old)

    Time frame: baseline, and when the child is 3 and 24 months old

  9. Mother's working alliance with home visitor (not for control group) (when the child is 3, 6, 12 and 24 months old)

    Time frame: not for control group,when the child is 3, 6, 12 and 24 months old

  10. Social-demographic data (all follow-up points: baseline, and when the child is 3, 6, 12, 18 and 24 months old)

    Time frame: baseline, and when the child is 3, 6, 12, 18 and 24 months old

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: CAPEDP

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Oct 26, 2006
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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