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Behavioral DisordersCAPEDPNCT00392847

Promoting Parental Skills and Enhancing Attachment in Early Childhood

A study testing Promoting Parental Skills and Enhancing Attachment and had home visits by community workers during pregnancy in people with Behavioral Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages Up to 26 years, women onlyHealthy volunteers can take part
Conditions the study is for
Behavioral Disorders
What is being tested?
Promoting Parental Skills and Enhancing Attachment and had home visits by community workers during pregnancy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
1 siteFrance
Study dates
Dec 2006to Jan 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 26 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Bichat-Claude Bernard Hospital

    Paris, 75018

Other trials in France

About this study

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

Read the detailed description

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.

Being tested
Promoting Parental Skills and Enhancing Attachment, had home visits by community workers during pregnancy
Keywords
Child mental disorder, Home visit, Postnatal depression, Social Support, Random selection
Medical subject headings
Mental Disorders, Neurodevelopmental Disorders, Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Promoting Parental Skills and Enhancing AttachmentBehavioural

    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 pregnancyBehavioural

    Also called to the child's second birthday.

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

Study groups in NCT00392847
Study groupRoleWhat they receive
2Active comparatorThe first group will receive routine follow-up as currently provided by national community health and social services.
Receives: Behavioral: Promoting Parental Skills and Enhancing Attachment
1Experimentalwill receive home visits by community workers. These visits will start during pregnancy and will continue up to the child's second birthday.
Receives: Behavioral: had home visits by community workers during pregnancy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

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

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

    Measured: when the child is 18 and 24 months old

Secondary outcomes (10)

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

    Measured: 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)

    Measured: 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)

    Measured: 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)

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

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

    Measured: 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)

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

  7. Mother's attachment (at baseline)

    Measured: at baseline

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

    Measured: 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)

    Measured: 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionAug 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00392847
Sponsor's protocol ID
P051045
Acronym
CAPEDP
Status last verified
Jul 2012
First submitted
17 Oct 2006
Last updated
10 Jul 2012
Results posted
No
Data monitoring committee
No

Publications

  • Dugravier R. [Understanding consequences of hospitalization within attachment theory]. Arch Pediatr. 2010 Jun;17(6):723-4. doi: 10.1016/S0929-693X(10)70078-6. No abstract available. French.

    PubMed 20654860

  • Guedeney A, Guedeney N, Tereno S, Dugravier R, Greacen T, Welniarz B, Saias T, Tubach F; CAPEDP Study Group. Infant rhythms versus parental time: promoting parent-infant synchrony. J Physiol Paris. 2011 Dec;105(4-6):195-200. doi: 10.1016/j.jphysparis.2011.07.005. Epub 2011 Jul 12.

    PubMed 21782020

  • Saias T, Lerner E, Greacen T, Simon-Vernier E, Emer A, Pintaux E, Guedeney A, Dugravier R, Tereno S, Falissard B, Tubach F; CAPEDP Study Group; Revah-Levy A. Evaluating fidelity in home-visiting programs a qualitative analysis of 1058 home visit case notes from 105 families. PLoS One. 2012;7(5):e36915. doi: 10.1371/journal.pone.0036915. Epub 2012 May 18.

    PubMed 22629341

  • Greacen T, Welniarz B, Purper-Ouakil D, Wendland J, Dugravier R, Saias T, Tereno S, Tubach F, Haddad A, Guedeney A; CAPEDP STUDY GROUP. BEST PRACTICE IN INDIVIDUAL SUPERVISION OF PSYCHOLOGISTS WORKING IN THE FRENCH CAPEDP PREVENTIVE PERINATAL HOME-VISITING PROGRAM: RESULTS OF A DELPHI CONSENSUS PROCESS. Infant Ment Health J. 2017 Mar;38(2):267-275. doi: 10.1002/imhj.21630. Epub 2017 Feb 25.

    PubMed 28236309

  • Dugravier R, Tubach F, Saias T, Guedeney N, Pasquet B, Purper-Ouakil D, Tereno S, Welniarz B, Matos J; CAPEDP Study Group; Guedeney A, Greacen T. Impact of a manualized multifocal perinatal home-visiting program using psychologists on postnatal depression: the CAPEDP randomized controlled trial. PLoS One. 2013 Aug 19;8(8):e72216. doi: 10.1371/journal.pone.0072216. eCollection 2013.

    PubMed 23977257

  • Tubach F, Greacen T, Saias T, Dugravier R, Guedeney N, Ravaud P, Tereno S, Tremblay R, Falissard B, Guedeney A; CAPEDP Study Group. A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France. BMC Public Health. 2012 Aug 13;12:648. doi: 10.1186/1471-2458-12-648.

    PubMed 22888979

Questions about this trial

What is this clinical trial studying?

A study testing Promoting Parental Skills and Enhancing Attachment and had home visits by community workers during pregnancy in people with Behavioral Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00392847, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.

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