| October 17, 2006 |
| July 6, 2012 |
| December 2006 |
| August 2011 (final data collection date for 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 ] [ Designated as safety issue: Yes ]
- Parental competencies (when the child is 3, 12 and 18 months old) [ Time Frame: when the child is 3, 12 and 18 months old ] [ Designated as safety issue: Yes ]
- Child mental health (when the child is 18 and 24 months old) [ Time Frame: when the child is 18 and 24 months old ] [ Designated as safety issue: Yes ]
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- Mothers’ scores on a postnatal depression scale (baseline, and when the child is 3, 6 and 12 months old)
- Parental competencies (when the child is 3, 12 and 18 months old)
- Child mental health (when the child is 18 and 24 months old)
|
| Complete list of historical versions of study NCT00392847 on ClinicalTrials.gov Archive Site |
- Child attachment (when the child is 18 months old) [ Time Frame: when the child is 18 months old ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Mother's attachment (at baseline) [ Time Frame: at baseline ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
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- Child attachment (when the child 18 months old)
- Family use of medical and Social services (baseline, and when the child is 3, 6,12 and 24 months old)
- Family Social support (baseline, and when the child is 3, 12 and 24 months old)
- Mother’s self-esteem as a parent (when the child is 3, 12 and 24 months old)
- Child psychomotor development (when the child is 6, 12 and 24 months old)
- Mother’s knowledge about child development (baseline, and when the child is 3 and 24 months old)
- Mother’s attachment (at baseline)
- Mother’s mental health (baseline, and when the child is 3 and 24 months old)
- Mother’s working alliance with home visitor (not for control group) (when the child is 3, 6, 12 and 24 months old)
- Social-demographic data (all follow-up points : baseline, and when the child is 3, 6, 12, 18 and 24 months old)
|
| Not Provided |
| Not Provided |
| |
| Promoting Parental Skills and Enhancing Attachment in Early Childhood |
| 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 |
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. |
| Interventional |
| Not Provided |
Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Behavioral Disorders |
- Behavioral: Promoting Parental Skills and Enhancing Attachment
The first group will receive routine follow-up as currently provided by national community health and social services.
Other Name: Promoting Parental Skills and Enhancing Attachment
- Behavioral: had home visits by community workers during pregnancy
had home visits by community workers during pregnancy to the child's second birthday.
Other Names:
- had home visits by community workers during pregnancy
- to the child's second birthday.
|
- Active Comparator: 2
The first group will receive routine follow-up as currently provided by national community health and social services.
Intervention: Behavioral: Promoting Parental Skills and Enhancing Attachment
- Experimental: 1
will receive home visits by community workers. These visits will start during pregnancy and will continue up to the child's second birthday.
Intervention: Behavioral: had home visits by community workers during pregnancy
|
- Dugravier R. [Understanding consequences of hospitalization within attachment theory] Arch Pediatr. 2010 Jun;17(6):723-4. French. No abstract available.
- Guedeney A, Guedeney N, Tereno S, Dugravier R, Greacen T, Welniarz B, Saias T, Tubach F; the CAPEDP Study Group. Infant rhythms versus parental time: Promoting parent-infant synchrony. J Physiol Paris. 2011 Jul 12; [Epub ahead of print]
- Saïas T, Lerner E, Greacen T, Simon-Vernier E, Emer A, Pintaux E, Guédeney 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. Epub 2012 May 18.
- Tubach F, Greacen T, Saïas 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.
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| |
| Completed |
| 440 |
| January 2012 |
| August 2011 (final data collection date for primary outcome measure) |
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)
|
| Female |
| up to 26 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| France |
| |
| NCT00392847 |
| P051045 |
| No |
| Assistance Publique - Hôpitaux de Paris |
| Assistance Publique - Hôpitaux de Paris |
| Ministry of Health, France |
| Principal Investigator: |
Antoine Guedeney, PU-PH |
Assistance Publique - Hôpitaux de Paris |
|
|
| Assistance Publique - Hôpitaux de Paris |
| July 2012 |