Assessment of the "Appui Parental": A Program of Early Support to Parenthood

NCT02895126 | Completed

• 1 other identifier: 9237
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

In so-called at risk families, the child-parent attachment relationship is more difficult to set up and this can be a barrier to social and emotional development of young children. To help parents build and sustain this relationship, and to prevent child development disorders, many parenting programs have been created, usually with frequent home visits by early childhood professionals. In France, therapeutic interventions at home are little used and they are not evaluated. In Montpellier, an action of this type has been conducted since 2001 by the "Conseil Départemental de l'Hérault" in collaboration with the University Hospital of Montpellier including, in addition to home visits, supervision of professionals: the Appui Parental Program. Before extending this action to other areas of Herault, the "Conseil Départemental de l'Hérault", the "Abri Languedocien" and the University Hospital of Montpellier are conducting an assessment to know the effectiveness of the program for families under care. This 3-year multicenter prospective study includes 88 children aged 1 to 20 months from families meeting vulnerability criteria previously defined, 44 benefiting Appui Parental program (experimental group) and 44 benefiting a regular support (control group). A paediatric examination on the basis of the Denver scale, parental questionnaires, questionnaires to professionals and an a video of infant-parent interactions are used. The data, collected at baseline and 18 months later, will be compared.

Conditions

Infant Development

Keywords

vulnerable family

Outcome Measures

Primary Outcomes (1)

• Symptom Check-List (SCL) score variation

  up to 18 months

Secondary Outcomes (1)

• Child Behavior Check-List (CBCL) score variation

  up to 18 months

Study Arms (2)

"Appui Parental" program (44 cases)

EXPERIMENTAL

Behavioral: "Appui Parental" program

Regular parental support (44 cases)

OTHER

Usual intervention

Behavioral: Regular parental support

Interventions

"Appui Parental" program BEHAVIORAL

"Appui Parental" program (44 cases)

Regular parental support BEHAVIORAL

Regular parental support (44 cases)

Eligibility Criteria

• Age: 1 Month - 20 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• family with child between 1 and 20 months of age and with parents eligible to parental support,
• written informed consent signed by both parents or 1 legal guardian,
• vulnerability criteria with difficulties to meet the needs of their child,
• family affiliated to social security.

You may not qualify if:

• mother having delusional psychosis,
• family whose child is in danger and needs an immediate protective measure,
• ongoing justice procedure for the child,
• family with impossibility to follow-up during 18 months,
• non French-speaking parents.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital

Montpellier, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 9, 2016
• Study Start: April 4, 2014
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

FR (1)