Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05273918

Acronym

SEPAGE

Enrollment

Registered

2022-03-10

Start date

2023-01-31

Completion date

2028-10-31

Last updated

2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit, Fetal Alcohol Spectrum Disorders, Hyperactivity Disorder

Keywords

FASD, ADHD

Brief summary

This is a multi-center, prospective, randomized, open-label, controlled trial with two parallel arms and blinded endpoint assessment. It aims yo compare the 6-month efficacy of a group CBT program versus body-mediated intervention (meditation) children (7-13 years) with ADHD-associated FASD and emotional dysregulation via a measurement of the Aggressive Behaviors subscale score of the Dysregulation Profile subset of the CBCL scale.

Interventions

OTHERcognitivo-comportmental therapy

15 workshops once a week during 90 minutes

OTHERbody mediation

15 workshops once a week during 90 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 13 Years

Healthy volunteers

Inclusion criteria

* child with fetal alcohol spectrum disorder * child with attention deficit disorder with / without hyperactivity * child with a score upper than or equal to 180 points on the Aggressive behavior, Anxiety / Depression and Concentration problems subscales of the CBCL * child followed in La Reunion, Montpellier or Bordeaux University Hospital * child whose parents are affiliated with social security * child who accepts to participate and whose parents have given their consent

Exclusion criteria

* non-french speaking child or parents / non-creole speaking child or parents * child who already participate to CBT or body mediation groups

Design outcomes

Primary

Measure	Time frame	Description
effectiveness of cognitive behavioral therapy program	7 months after inclusion	score on Child Behavior Check List (CBCL) scale. Minimum value = 50 (normal) and maximal value = 100 (pathologic). Score between 50 and 65 is mormal and score between 70 and 100 is pathologic and needs patients medical care.

Countries

France, Reunion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026